Four ways for assisted living operators to facilitate transitions

(Originally titled, "Four Ways for ALFs to Facilitate Transitions for Dementia Residents.")


My wife, Clare, who has Alzheimer’s disease, recently entered the “Reflections” unit for residents with dementia in an Assisted Living Facility (ALF).  Clare’s transition from home to ALF was about as good as I could have hoped for.  However, there are four steps that our ALF could have taken to make this transition much easier for both of us. 

1.  Issue a staff list to caregivers.  When we visited the ALF where Clare was eventually placed, we received a folder with lots of helpful information.  However, not even after Clare became a resident did I ever receive a list of personnel responsible for Clare’s welfare.  I was introduced to the Director of her “Reflections” unit when he conducted the intake assessment, and I had already met the person responsible for relations with caregivers.  But I was never given a list of the aides on the three shifts responsible for Clare during each 24 hour period. 

I could have familiarized myself much more quickly and easily with the names of the many aides who help Clare had I been provided a staff list.  The list should also have included names/titles/areas of responsibility of all administrators and supervisors responsible for Clare’s care.  In addition, the direct line telephone numbers and email addresses for all administrators and supervisors should have been provided.  I eventually obtained all of this information during the first few weeks, but had that information been given to me upon Clare’s admittance it would have saved me a lot of time and effort.

2.  Provide easily readable name badges for personnel.  The ALF we selected provides name badges for its personnel that are the exact opposite of what is helpful to residents and caregivers.  The name of the ALF is very prominent and in large size lettering on a metallic badge.  The name of the employee is in much smaller size lettering.  And the employee’s title is in even smaller size lettering.  Except for the administrative personnel, the names and titles of employees are typed in 10 or 12 point font on a piece of white tape on the bottom of the badge.  I have 20/20 vision, but in order to read a person’s name and title clearly I must get very close to that person, almost violating their “personal space.”  I know that the ALF is proud of its name and wants to market its name, but for caregivers who shave already placed their loved ones in that facility, what is important is the name and title of the people working with their loved ones, not the name of the facility.  

3.  Provide removable name badges for residents.  When Clare attended day care programs, each morning she and all the other participants were given name badges upon arrival with names printed in very large 36 point font size, easily readable from a distance.  When participants left at the end of the day, the name badges were collected to be used the following day.  This was very helpful for Clare because she cannot remember names anymore.  I think that ALFs should consider a similar practice for residents in their dementia units.  Even after several weeks of being with her fellow residents 24/7, Clare is still unable to remember the names of most of her new friends.   If every dementia resident wore a name badge, identification would be a lot easier.  Needless to say, it would also make it easier for caregivers to identify a resident’s friends when they come to visit.

4.  Establish formal meeting schedule with caregivers to discuss resident care.

Dementia unit administrators in ALFs should schedule meetings with the primary caregiver of a dementia resident on a regular basis.  These meetings would provide a formal opportunity for facility administrators to provide primary caregivers with a status update on how their loved ones are faring, and offer an opportunity for primary caregivers to ask questions and offer suggestions with respect to activities, medication protocols, etc.  Too often the observations and perceptions of caregivers are not thoroughly considered, and that is wrong.  Even with a dementia resident no longer living at home with a 24/7 caregiver, that caregiver has important history and insights that should be considered on an ongoing basis after admittance.  Meetings could be modeled along the lines of federally mandated school district Committee on Special Education (CSE) meetings for classified special education students.  For CSE meetings, parents are invited to attend so district administrators can provide a status update on how their children are doing, and so parents have an opportunity to ask questions and offer suggestions on any perceived needs for improvement. 

I would advocate that such meetings be offered to caregivers of dementia residents one month after resident admission, and then once every three months after that date.  As a retired principal, I can understand the reluctance of ALF administrators to add yet more meetings to their schedule.  However, as a caregiver whose wife is in such a facility, I can attest to the difficulty of finding the people I need to speak with on any given day due to different work shifts.  At least if I knew a meeting was scheduled in a given week, I could maintain a list of questions knowing that the administrators will all be there to respond to my questions at our scheduled meeting. 

Although these four suggestions are based upon my own personal experience with one ALF, I know from many others in my support groups that I would probably be making one or more of these same suggestions had Clare been placed elsewhere.  ALFs should be issuing staff lists to caregivers upon admission of their loved ones, providing personnel with easily readable name badges, providing dementia residents with easily readable name badges so they can readily identify each other, and scheduling formal meetings with caregivers to discuss resident progress.

Published as guest blog column in McKnight's Long-Term Care News. December 20, 2013.  Access online only at www.mcknights.com/blogs/section/2907/

The NFL and Alzheimer's - Go Purple

(Note: This article was originally titled, "The NFL and Alzheimer's ... Pink and Purple")


A 2012 study of nearly 3500 former National Football League (NFL) players concluded that ex-NFL players were three times as likely as the general population to die from a neurodegenerative disease such as Alzheimer’s. Two studies published in 2013 concluded that even one concussion can cause degenerative brain changes similar to those with Alzheimer’s.  

Aware of the links between concussions and Alzheimer’s, the NFL has adopted stronger rules to help minimize head injuries, and in 2012 donated $30 million to the National Institutes of Health (NIH), in part to research “the potential relationship between traumatic brain injury and later life neurodegenerative disorders, especially Alzheimer’s disease.” In 2013, the NFL announced a $60 million partnership with General Electric Co., in part to research brain injuries. 

And now comes news of a $765 million dollar settlement between the NFL and more than 4500 retirees and families of players who have died of diseases they claimed were due to head trauma. One former NFL player noted that the lawsuit was never intended to harm the NFL, but that former players “wanted to raise awareness about their injuries.”

In 1983 when President Reagan designated November as National Alzheimer’s Awareness Month, fewer than 2 million Americans had Alzheimer’s. Today more than 5 million Americans have Alzheimer’s. Without a medical breakthrough, those numbers are expected to rise to more than 7 million by 2025 and more than 14 million by 2050. 

Already our 6th leading cause of death, Alzheimer’s is the only disease among the top ten killers in the U.S. with no effective means of prevention, treatment, or cure, and deaths due to Alzheimer’s have increased 68% between 2000 – 2010. Care for people with Alzheimer’s costs our nation more than $200 billion each year, with $140 billion of that amount paid by Medicare and Medicaid. Projected annual costs are expected to exceed $1 trillion by 2050. 

The most watched TV programs each year are NFL games and such large audiences give the NFL a tremendous opportunity to use its broadcasts for public service. To their credit, since 2009 the NFL has used October broadcasts to support breast cancer awareness and help raise money for research. Football players show their support by wearing pink on their uniforms and using pink equipment. Having lost my mother to cancer, and with relatives currently dealing with cancer, I applaud this NFL leadership role and enjoy seeing lots of pink on my TV screen in October.

Another opportunity for leadership would be for the NFL to dedicate November broadcasts to Alzheimer’s awareness. Aside from raising money for Alzheimer’s research, such attention would help more people recognize possible Alzheimer’s symptoms that they or their loved ones are experiencing so they can follow up with their doctors. And more people caring for loved ones with Alzheimer’s could learn about additional resources to help them as caregivers. Football players would undoubtedly agree to show their support for Alzheimer’s awareness by wearing purple on their uniforms and using purple equipment.

NFL Commissioner Goodell once said, “A lot of times, you know the right thing to do. But you have to have the courage to do it.” Using NFL broadcasts to promote Alzheimer’s awareness and research is the right thing to do.

Pink is a beautiful color. So is purple.

Published as a guest column on the "by 2020" blog of USAgainstAlzheimer's website, October 29, 2013.  Access at: www.usagainstalzheimers.org/blog.

Weighing a Difficult Decision: The 'When' and 'Where' of Assisted Living Placement

Note:  The original submission below was titled, "When it is Time for Assisted Living."

As a spouse caregiver for my wife, Clare, who was diagnosed with young onset Alzheimer’s Disease (AD) in 2009, I have faced some very painful decisions.  Without doubt, until recently the most painful decision was about driving.  When I had my first discussions with Clare about how it was no longer safe for her to continue driving, we argued like never before ... amid many tears by both of us.  After our initial discussions, I realized that Clare was not going to stop driving without a lot of pressure from me.  Members of my spouse support group at the Long Island Alzheimer’s Foundation (LIAF) had prepared me well for those emotional discussions.  They told me that taking away the car keys was going to be a painful decision, but one I had to make.

However, no amount of support can really prepare someone for the crying and screaming of a spouse trying to fiercely hold onto a symbol of independence, especially when that spouse is in denial and still feeling that he or she can drive safely.  Although there are differences of opinion as to when someone with AD should stop driving, I feel very strongly that driving should end once there is an AD diagnosis ...  if not immediately, then certainly within a few months.  Once there is an AD diagnosis, it’s no longer a question of if it is unsafe to drive ... the only question is when.  As AD worsens, one’s ability to drive safely will become increasingly impaired, and no one can predict just when that impairment might cause an otherwise preventable accident.  Therefore, in my opinion, it makes sense to stop driving before people are injured or property is damaged, rather than continue to drive until an accident actually happens. 

When a loved one has AD, the caregiver must eventually decide when to take full responsibility for completing all routine household tasks, administering medication, and providing increased assistance with various activities of daily living.  Along with these decisions, when the caregiver’s need for respite time requires placing loved ones in day care programs, or hiring part-time home companions or aides, all can be very emotional times for caregivers.  They all were for me but, until recently, I still would still have said that taking away the car keys was the most emotionally difficult decision I’ve had to make as a caregiver.  However, as Clare‘s decline spiraled downward, I’ve since had to make another decision that proved to be even more painful than ending her driving days.  I decided it was time to place Clare in an Assisted Living Residence (ALR).  Without doubt, if I now had to describe the one most gut-wrenching and emotionally draining decision I’ve ever had to make as a spouse caregiver, this is it.

For many months prior to making this ALR decision, I was becoming more and more stressed due to Clare’s worsening impairment, especially her lack of any short term memory.  Her inability to retain any information led to two very frustrating behaviors.  I referred to the first one as “Groundhog Day” syndrome.  Over and over, Clare would ask me the exact same questions, totally unaware that she was asking me the same questions I had just answered moments earlier.  It became incredibly difficult for me to respond as if it was the first and only time she had asked me that question.  The second very frustrating behavior was a complete inability to carry out a simple one step direction because she would forget in a matter of seconds.  I would remind her of a simple procedure, such as to place food back in the refrigerator after eating, but she would always forget.

Cognitively, Clare was having increasing difficulties processing information.  Acutely aware of what was happening to her, and knowing there were fewer and fewer things she could still do successfully at home, Clare was constantly asking to “help me” around the house.  If I said no, she’d get angry and say things like, “There are so few things I can still do.  Please let me do that.  I can still do that.”  If I said yes, she’d invariably start doing that task incorrectly.  If I would correct her or ask her to stop so I could take over, she would say with anger in her voice something like, “Well, if you had told me to do that, I would have done that.”  Of course, I had told her to do precisely that, several times, but she just couldn’t process the information or remember what I had said. 

As her memory and cognition worsened, along with her aphasia, Clare was also starting to lose her thoughts midway through asking me a question or making a comment.  She also began speaking incoherently at times and I was increasingly unable to understand what she wanted to say to me.  I knew I desperately needed more respite time and, prior to considering an ALR placement, I gradually upped Clare’s time in day care programs.  She originally went once a week for 4 hours and that eventually increased to four days a week for a total of 22 hours.  Whereas I appreciated the additional respite time by myself, time spent with Clare at home was also changing.   Clare could no longer read easily or play her favorite word games independently, and she had lost interest long ago in piano, guitar, and other favorite activities.  Because she could no longer do anything independently, from the time we got home after I picked her up from day care until the time we went to sleep, all we did was watch TV together.  Often we watched the same repeat broadcasts over and over because, to Clare, her favorite repeat show was always “new” to her. 

Clare was now feeling tired all the time and her need for sleep increased.  If she didn’t sleep for at least 11 hours, it would be very difficult to wake her up the next morning in time to go to day care.  We would watch TV in our den starting at 4 p.m. every weekday, go to our bedroom before 7 p.m. to give Clare sufficient time to get ready for bed, and then watch TV in bed until 9 p.m. when I would turn off the sound so she could go to sleep.  On weekends, Clare would sleep for up to 15 hours, and then we’d sit and watch TV all day unless seeing friends or family.  Often when I would suggest that we take a walk or go somewhere, Clare would say she was too tired and preferred to just sit and watch TV.  So ... we sat and watched TV together.  Whenever I would leave her side for a few minutes to check email or to do something else, Clare would come to find me saying she was bored by herself or didn’t know where I was.

The worst and most frustrating effect of all these changes in our lives was that for the first time in our 46 years of marriage, matters of personal hygiene, dressing properly and selecting clothing appropriate for the weather, daily medication, eating, and a host of other issues were causing daily arguments and shouting matches.  We were arguing more in a period of several months than we had probably argued in all of our previous years of marriage put together.  I also noticed that things were starting to “fall through the cracks.”  I had so much on my mind trying to help Clare get through each day that on some days I’d forget to remind her about important matters.  All of these “falls” invariably led to more stress, and the stress led to more arguments.

That is when I started to think about whether the time had come for me to consider an ALR placement for Clare.  Instead of leaving our house at 9 a.m. for day care programs and picking Clare up in time to arrive home at 4 p.m., I envisioned that she would simply wake up in the ALR and have an even better quality day care program during those same hours.  I could then arrive at the ALR at around 4 p.m. and there would be nothing to argue about.  With the ALR responsible for all of the activities of daily living, and with no household tasks for Clare to “help me” with, and with no “reminders” I would have to give to Clare, I imagined that all of our time together in the ALR would be quality time spent hugging and talking and laughing.  We could even spend some of that time watching TV together just as we did at home if that’s what Clare wanted to do.  I envisioned “signing her out” occasionally so we could go to eat at her favorite restaurants, and signing her out on some weekends so we could spend time with friends and even take short day trips as long as her health would still allow for such activities.  The more I thought about the benefits of an ALR placement at this time, the more I knew I had to learn more.

I intuitively knew that Clare was not going to accept an ALR placement easily, so when I first spoke with Clare about the need to check out ALRs, I said that it was just so we would be prepared and know where she would go when the time came.  I said that knowing “the where” and “the when” were two different decisions.  Clare readily accepted that she will need to enter an ALR at some point, so she was okay with the decision to find “the where.”  When we did our retirement planning well over a decade ago, we discussed what we wanted to do in the event either of us would eventually need a high level of care.  We both agreed that we didn’t want live-in help and both preferred to enter into an assisted living facility or nursing home what that time came. As a result of those discussions, we purchased long term health care insurance to help cover eventual costs.  However, I’m not sure that a loved one with AD, whose brain still provides many lucent moments and who remains deeply in love with and dependent upon a caregiver, will ever be ready for “the when.”  Therein lies the source of the intense emotional pain for the caregiver who must make that “when” decision. 

I placed the “when” issue temporarily aside, and over the course of several weeks I did my research and selected six ALRs that I thought would provide Clare the best possible care and greatest opportunity to be happy.  Wanting Clare to be part of the decision-making process for “the where,” we toured facilities together and agreed upon the one we felt was best.  We then returned to that same ALR a second time for one more opportunity to observe residents interacting during their lunchtime and observe resident and staff involvement in various activities.  Still agreed that this was the best place, I returned to meet with the director by myself the following week, signed several forms, and gave a deposit to place Clare on a waiting list.  I left the director’s office, got into my car, and just sat there and cried for several minutes.  

I knew that by placing a room deposit, I was accepting that “the when” had somehow already arrived.  Intellectually, I knew that it was the right decision.  Emotionally, however, I still was not completely prepared to “let Clare go” and live apart for the first time in our marriage.  I cried a lot that day ... and for several days afterwards.  With two other women ahead of Clare on the room waiting list, the director said that a bed could be available for Clare in a matter of weeks, or the wait could be several months.  I was thankful that I would still have time to prepare myself emotionally for this new reality.

Writing this article more than a month after placing that deposit, I can now say that I feel emotionally prepared to place Clare whenever that room becomes available.  I am pleased that Clare is happy with “the where” and feels that the ALR we selected will be a good place for her ... even if she feels that a placement is not necessary yet.  However, her worsening behaviors and our daily arguments have reinforced my emotional acceptance of the need for such a placement as soon as a room becomes available.  I no longer feel “caregiver guilt” that all caregivers know so well when having to make emotionally difficult decisions that they know their loved ones do not want them to make. 

Just as with the driving issue, “the when” for an ALR placement is a decision that must be made solely by the caregiver because a person with AD has mental impairment that precludes objective participation in such a decision.  And just like the decision four years ago to take away the car keys, this ALR placement decision is in Clare’s best interests.  Even if things do not work out exactly as I had envisioned, I know that once placed in the ALR Clare will be in a safe and caring environment 24/7.  She will have highly trained and highly skilled people taking care of her.  Her daily activity schedule will allow her the socialization and mental stimulation she needs to keep her mind actively engaged in enjoyable activities.  She will eat nutritional meals each day and be able to maintain a high quality of life with dignity.  In short, she will receive all of the care I want her to have.

Will our nights alone feel lonely?  Yes.  Will our large house feel empty?  Yes.  Will we miss each other?  Yes.  But we will not miss those daily arguments, and we will not miss the stress caused by those arguments.  And I will not miss the stress caused by trying to remember all that I now must remember each day in order to properly provide for Clare’s needs. 

I cannot now imagine a decision more painful to make as a spouse caregiver ... but it is the right decision to make at this time in our AD journey.  Whenever I do receive that phone call from the ALR director telling me that a bed is available for Clare, I’m now as emotionally prepared as I’ll ever be to say yes.  It will be an incredibly painful and emotionally difficult day, but we will somehow get through it.   It is time for assisted living.

Published in care ADvantage, Fall 2013, Vol. 9, No. 2, pp. 10-13.  Access at: www.alzfdn.org/Publications/care_advantage/issues/ca_fall13.pdf

Three Important Actions for Alzheimer's Caregivers

Many caregivers for people with Alzheimer’s Disease (AD) do not learn quickly enough about three important actions that they should take as soon as possible after their loved one is diagnosed with AD.  Were health care professionals to suggest these three actions, caregivers’ lives would be a lot less stressful as they try to provide the best care possible for their loved ones.

The first and most important action that all caregivers should take is to seek out and join a caregiver support group, preferably one that meets on a weekly basis and preferably one designed solely for others in similar caregiver roles.  All AD caregiver support groups can be helpful.  However, if a caregiver joins a “targeted” caregiver group ... such as a group whose members are all spouses of people with AD, or a group whose members are all children caring for parents with AD ... the caregiver can receive more helpful suggestions and information about caregiving from others in similar positions.  Just as or even more important, in a targeted group caregivers can receive the emotional support that is so badly needed from others who are in similar situations ... others who “get it” and can fully appreciate what everyone in the group is experiencing.  Caregivers in support groups soon learn that the course of this disease varies widely, and a common expression one hears is, “If you know one person with Alzheimer’s, you know one person with Alzheimer’s.”  However, there are more similarities than differences, and certainly the caregiver’s relationship with the person with AD ... as a spouse, a child, another friend or relative ... will greatly affect the caregiving process. 

Fortunately, I have participated in a wonderful weekly support group designed solely for spouse caregivers sponsored by the Long Island Alzheimer’s Foundation (LIAF).  In addition, I also participate in an online support group designed exclusively for AD spouse caregivers, at www.thealzheimerspouse.com.   Sadly, no health care professional ever advised me of the existence of such real and online groups.  I had to learn about such groups on my own.  And that must change.

The second important action for all caregivers is to meet with an attorney who specializes in eldercare issues.  The attorney will offer guidance to be sure that all end of life documents are in order  ... wills or trusts, living wills, health care proxies, and durable power of attorney … and, if not, the attorney can prepare such documents.  Caregivers should also discuss a long term health care policy if their loved one with AD does not currently have such insurance.  A policy may now be too costly to initiate or the person with AD may no longer even qualify.  However, the eldercare attorney should discuss such options with the caregiver as part of a comprehensive review.  Once again, no health care professional ever advised me to do this, but we talked about the need to do so in my spouse support group.

The third important action that all caregivers should take is to meet with a certified financial advisor to discuss preserving, protecting and growing current income, investments, and other assets.  This is also another opportunity for caregivers to discuss long term health care policies that may impact other financial decisions.  As loved ones with AD decline, caregivers will slowly but surely discover their need for respite time.  Hiring part-time home health aides, companions, and enrolling loved ones in day care programs will be considered.  As the AD decline worsens even more, caregivers will wrestle with the need to hire full-time home health aides or private nurses, or consider placing their loved one in assisted living residences, nursing homes, or hospice facilities.  All of these decisions have financial implications, and a financial advisor can help the caregiver plan more wisely for the future.  Again, no health care professional ever advised me to seek out a financial advisor, but we talked about this need in my spouse support group.

Caregivers cannot prevent the inevitable outcome once loved ones are diagnosed with Alzheimer’s.   However, health care professionals can empower caregivers by suggesting these three actions ... join a good support group, meet with an eldercare attorney, and meet with a financial advisor.  Health care professionals who do this will enable caregivers to better protect and provide for themselves and their loved ones ... emotionally, legally, and financially.  

 

Published online in Clinical Geriatrics on 10/1/13. Access at:
http://www.clinicalgeriatrics.com/content/Three-Important-Actions-Alzheimer%E2%80%99s-Caregivers. This same article will be published in the October issue of its sister publication, Annals of Long Term Care.

Caregiver Support Groups

In those first weeks and months after an Alzheimer’s disease diagnosis, caregivers have many questions, fears, and concerns about confronting upcoming changes in their lives.  I know this from personal experience because I am a caregiver for my wife, Clare, who was diagnosed with early/young onset Alzheimer’s disease at age 63. 

Immediately after Clare’s diagnosis, I had many unanswered questions.  Is it still safe for Clare to continue driving?  Is it still safe for me to leave Clare alone at home?   Are there any special medications that should Clare start taking?  Should I contact our attorney to see if we need to update any of our end-of-life documents … will, living will, health care proxy, and durable power of attorney?

I knew that these types of questions and many other issues are routinely discussed in caregiver support groups.  However, it is not always easy to find a local caregiver support group.  The Alzheimer’s Association provided more than thirty different caregiver groups on Long Island, but none were specifically for spouse caregivers.  Eventually, I was fortunate to find a support group solely for spouse caregivers at the Long Island Alzheimer’s Foundation (LIAF) in Port Washington, NY.  This group, led by a gifted social worker, met every Tuesday afternoon and would soon grow to 15 participants ranging in age from the late 50s to the mid-80s.

Regardless of age or gender, we all “got it” in my spouse caregiver group.  We were dealing with many, if not all, of the same behaviors and although each of our individual situations were somewhat different, it was helpful to learn how others were handling similar situations.  Those like me, whose spouses were then in the earliest stages of Alzheimer’s, received much wisdom from those who had already dealt with such issues.  We also learned about strategies that others used with spouses at more advanced stages, knowing that one day we might also have to deal with similar situations.  All spouse caregivers are swimming in the same lake; we may be paddling in different boats at different speeds, but we are all trying to stay afloat in Lake Alzheimer’s.

I absorbed many practical bits of advice each week as we shared and discussed everything on our minds … new and worsening behaviors, medications, and any other topic of concern.  We could laugh, cry, and say whatever was on our minds in a totally non-judgmental environment, receiving emotional support and helpful suggestions for dealing with whatever issues confronted us. 

After three years I had to stop attending my support group so I could take Clare to a day care program in a different location on that day, but I haven’t completely severed my group ties.  Each week I now join up to a dozen current and former support group members for lunch.  All of our spouses are now either in moderate or severe stages, or have already passed on.  But just as we once did in our formal support group, we continue to support each other.  As one member of this informal group recently said to me, “This new group just seems to scratch every itch I have!”

As the numbers of people diagnosed with Alzheimer’s disease increases dramatically, we will need to provide more weekly caregiver support groups.   Doctors must become more familiar with support groups available to their patients and caregivers. Clare and I saw an internist, a neurologist, and two geriatric psychiatrists, yet none of them mentioned anything about joining support groups.  In my LIAF spouse support group of 15, only one had been referred there by a doctor.  That is a shame.

Doctors working with someone who is caring for a spouse, parent, grandparent, friend or other family member with Alzheimer’s disease should urge them to join a support group.  Let them know that they can learn many practical suggestions from those who have “been there,” and how important it is to have a place where they can talk openly about their feelings, fears, and concerns while receiving emotional support from others “who get it.” 

Caregivers should not have to “go it alone” when a loved one is declining from an incurable disease.  But unless doctors inform them of the existence and value of support groups, many who would find emotional and practical help there will lose out on this wonderful source of information and comfort.

Published in Journal of the American Geriatrics Society, August, 2013, Vol. 61, No. 8, p. 1413.  Access at:

http://onlinelibrary.wiley.com/doi.10.1111/jgs.12369/full

Two recommendations for Alzheimer's medication protocols

Since becoming a caregiver for my wife, diagnosed in 2009 with early onset Alzheimer’s Disease (AD), I have participated in AD spouse caregiver support groups.  Several participants have reported that their spouses had been taking AD medication without incident for a year or more, only to then show symptoms that may have been caused by the medication.  Spouses reported that these side effects disappeared when the medication was discontinued.  A review of data that led to FDA approval for current AD medications reveal that of the 11 clinical trials conducted prior to marketing, all but two lasted for 26 weeks or less.  Not one lasted for even one full year.  Each trial noted side effects by a small percentage of users, but none were considered severe enough to prevent the medication from being approved. ¹  There have also never been any follow-up studies to learn if patients who continued taking the medication exhibited worsening side effects, or developed new side effects, after those trials ended. 

 

My wife had been taking two AD medications for several years with no negative side effects.  However, despite no observable changes in diet, she suddenly began exhibiting gastrointestinal symptoms noted as side effects in the AD medication clinical trials.   I decided to slowly wean my wife off both medications to see if they might be the cause of her gastrointestinal issues, and the effects were immediate.  Within a few days, all of her gastrointestinal symptoms stopped.  No more gassiness.  No more nausea.  No more vomiting.  Cause and effect?  All I can say for sure is that her gastrointestinal issues ceased when she stopped taking AD medication that, based upon research, was no longer helping her anyway.  A 2012 study by Consumer Reports found no evidence of any of the four approved AD medications being effective beyond three months for most people. ²  Research by the Alzheimer’s Association found that these four medications may be effective for up to a year for about half of the people using them. ³  And the NIH states in its most recent report on AD that the four currently approved AD meds “may help some people,” but even then, “only for months to a couple of years.” ⁴  

Despite reports doubting positive effects of AD medication over the long term, despite the fact that no clinical trial even lasted for one full year, and despite the fact that there have been no follow-up studies to gauge side effects over time, many doctors continue prescribing these medications for their AD patients year after year after year.  Perhaps this would not be so if medication were clearly labeled and marketed as having limited usefulness and should be discontinued after a limited period of time.  Therefore, I have two recommendations for future AD medication protocols:

1.  Protocols should mandate that clinical trials last for at least one full year. Should medication only prove effective for a lesser period of time, FDA approval could still be sought on the basis of demonstrated short term effectiveness.  However, all inserts and labels packaged with the medication, as well as all media advertising, should clearly state that this medication was only shown to have positive effects for some people with AD for the limited number of months such effectiveness was actually demonstrated in the clinical trial. 

2. Protocols should mandate that 18 months after the one year clinical trial ends, patients must receive a follow-up questionnaire about side effects.  If significant numbers of patients report new or worsening side effects, this data must be reported to the FDA to determine if such information should be reflected in future medication packaging and media advertising.

Too many people with AD are taking expensive medication for long periods of time when there is absolutely no clinical data demonstrating that these medications are still effective.  It is also possible that, over time, these medications may be causing unpleasant side effects.  Medication labels and media advertising should provide patients and their caregivers with truthful information to help them make the best decisions possible in consultation with their doctors.

1. “Aricept ... Highlights of Prescribing Information.” Accessed online at www.aricept.com/assets/pdf/AriceptComboFullPIFebruary2012.pdf, pp. 7-11.

 
“Razadyne” ... “Full U.S. Prescribing Information.”  Accessed online at www.razadyneer.com/sites/default/files/shared/pi/razadyne_er.pdf pp.2-4.

“Exelon” ... “Highlights of Prescribing Information.”  Accessed online at www.pharma.us.novartis.com/product/pi/pdf/exelon.pdf, pp. 13-16. 

“Namenda Full Prescribing Information.”  Accessed online at www.frx.com/pi/namenda_pi.pdf,  pp.3-8.  All four medication sites accessed on March 5, 2013.

2.  “Evaluating Prescription Drugs Used to Treat: Alzheimer’s Disease.”  Consumer Reports, May, 2012, p. 3.

3.  “Five FDA Approved Alzheimer’s Drugs.”  Research Center, Science & Progress Treatment Horizon section.  Accessed online at  www.alz.org/research/science/alzheimers_disease_treatments.asp. Accessed on March5, 2013.

4.  “A Primer on Alzheimer’s Disease and the Brain.”  NIH Alzheimer’s Disease Progress Report, 2011-2012, p. 9.  Accessed online at www.nia.nih.gov/alzheimers/publication/2010-alzheimers-disease-progress-report-deeper-understanding/brief-primer.  Accessed on March 5, 2013.

 

Published in Clinical Trials: Journal of the Society for Clinical Trials, August, 2013, Vol. 10, No. 4, pp. 637-638.  Access at: http://ctj.sagepub.com/content/8/5/679.full

 

 

Current Alzheimer's Medications: Effective Treatments or Expensive Bottles of Hope?

I am not a medical researcher, nor am I a medical doctor.  I am, however, a spouse caregiver for my wife, who is now in moderate stages of Alzheimer’s Disease (AD).  While admittedly lacking an M.D. degree, my reading of the AD literature, my listening to other spouse caregivers, my observations of more than a dozen people with Alzheimer's ,and my research on the effectiveness of current AD medications all tell me that doctors too often recommend that Alzheimer’s patients continue taking ineffective “treatment medications.”  Well after the time period when even the pharmaceutical manufacturers claim that their products are effective, many doctors continue to prescribe these same ineffective AD medications for their patients. 

History

My wife took two of the most commonly prescribed AD medications, donepezil (Aricept) and memantine (Namenda).  Along with galantamine (Razadyne) and rivastigmine (Exelon), these are four of the five prescription medications that have been approved by the U.S. Food and Drug Administration to treat people diagnosed with AD.  A fifth medication, tacrine (Cognex), was also approved by the FDA, but it is now rarely prescribed due to safety concerns. ¹  All but memantine are termed “cholinesterase inhibitors”  that “prevent the breakdown of acetylcholine, a brain chemical believed to be important for memory and thinking.” ¹  Memantine works differently by regulating glutamate, a brain chemical that, “when produced in excessive amounts, may lead to brain cell death.” ¹ Each of these medications carries the possibility for side effects such as nausea, vomiting, or diarrhea, to name a few.¹

Research
Although there is absolutely no research to indicate that any of these medications will stop or cure Alzheimer’s, there is some research to indicate that, for some patients, these medications may slow the rate of decline for a brief  period of time.  However, this research is based on only a few clinical trials of very short duration, and this research is badly flawed in two major respects.

The first research flaw is that the “significant positive outcomes” obtained in clinical trials cited by drug manufacturers as “evidence” of the effectiveness of their medications are usually based upon results obtained on the MMSE or ADAS-Cog tests.  The MMSE, a commonly used AD screening test, is an instrument that was never designed to diagnose Alzheimer’s and cognitive declines in some people with early to moderate stage AD score may not be accurately measured. ²  The ADAS-Cog, according to two studies reported in 2012, is a test instrument “not subtle enough to properly track changes in the early stages of Alzheimer’s. ³   A major study conducted by Consumer Reports in 2012 concluded that the differences in scores on the ADAS-Cog for patients taking any of the FDA approved medications, when compared to placebo groups, are “smaller than 4 points, which is so small, it is not considered meaningful.”  Consumer Reports also concluded that the “small improvements” showing slower rates of decline in activities of daily living as measured by various instruments “would not be considered clinically meaningful by most doctors.” ⁴

The second research flaw is that clinical trials cited as evidence of the effectiveness of these medications are few, and of very brief duration with absolutely no data supporting any positive outcomes beyond that clinical trial duration.  I would think that if any pharmaceutical manufacturer had any evidence of its medication having any positive effects beyond the duration of their brief clinical trials, that evidence would be made public ... in a heartbeat!

I went to the website of each medication to learn about the clinical trials in support of their effectiveness and found similar results for each medication.  All had clinical trials of short duration, all of the positive effects were leveling off or slowing down by the end of the trials, and all testing was with instruments that are not necessarily the best measurements of cognitive performance.

The website of Ortho-McNeil Neurologics, a division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., cites only 4 randomized, double blind, placebo controlled clinical investigations for galantamine in patients with probable Alzheimer’s. ⁵  Using the ADAS-Cog to assess cognitive performance, the 4 trials lasted 21, 26, 26, and 13 weeks, respectively.  At the end of these short duration trials, results had already either leveled off or begun to decline, even for the groups demonstrating initial improvement.

There is not even one study demonstrating that galantamine is effective to any degree whatsoever beyond 26 weeks. ⁵

On the Novartis website, one finds data from five clinical trials with AD patients that lasted 12, 24 and 48 weeks using rivastigmine in oral or “patch” form, and all relied upon the ADAS-Cog and MMSE to measure outcomes.  All trial results show that even for the groups demonstrating improvement on the medication, declines in scores appear after 24 weeks.  There is not even one study demonstrating that rivastigmine is effective to any degree whatsoever beyond 48 weeks.  ⁶

On the Eisai/Pfizer website, one finds data from 4 clinical trials with AD patients taking donepezil.  Two trials were for patients with mild to moderate AD, one for 15 weeks and one for 30 weeks.  Two trials were for patients with moderate to severe AD, for 24 weeks in Japan and six months in Sweden.  Once again, even for groups demonstrating improvement on this medication, declines in scores begin at or before the 24 week stage as measured by the ADAS-Cog and other instruments. There is not even one study demonstrating that donepezil (Aricept) is effective to any degree whatsoever beyond 30 weeks. ⁷

Discussion

What do all clinical trials using cholinesterase inhibitors tell us?  Very simply, we learn that of the 11 clinical trials for these three medications, 9 of them lasted for 26 weeks or less.  We also learn that in every study, even patients showing initial evidence of improvement started to decline after 24 weeks, if not sooner. 

And, finally, we learn that there is absolutely no evidence indicating that patients continuing to take these medications beyond a very limited period of time, one year or less, will continue to demonstrate any positive effects these medications may have had.   If there were such evidence in any clinical trial of any cholinesterase inhibitor, this clinical trial data would be heralded by both the pharmaceutical company and by the FDA as the greatest breakthrough ever in Alzheimer's treatment.

And what do we learn from clinical trials about the evidence of effectiveness of memantine?  On the Forest Laboratories, Inc. website, two studies are reported, one lasting 24 weeks and one for 28 weeks.  Outcomes were measured using two instruments, one to measure activities of daily living and one to measure cognitive function.  In the 28 week study, after four weeks, the group receiving a placebo started to decline; the group receiving memantine showed a slight improvement for 12 weeks, and then started to decline.  In the 24 week study, the treatment groups were different.  One group received memantine and donepezil, while the other group received memantine and a placebo.  After 4 weeks, the group receiving memantine and the placebo started to decline, whereas the group receiving memantine and donepezil didn’t show declines until the 8 week point.  There is not even one study demonstrating that memantine (Namenda), given with or without donepezil, is effective to any degree whatsoever beyond 28 weeks. ⁸

Despite there being no research to support the effectiveness of these AD medications beyond a few months, at best, many doctors continue prescribing these medications for years and years.  Not only can these AD meds no longer be helping their patients, but they may actually be causing some harm.  Maintaining patients on these medications long term may provide false hope to patients and their caregivers.  I refer to these medications as “bottles of hope” because as I watch my wife decline, I know that the medications cannot possibly be helping anymore, if they ever did at all. 

For many patients and caregivers, the high costs of AD medications present an economic hardship.  Money spent on AD medications is money that might otherwise be spent on day care programs, companions, home health aides, or other services that would actually improve the quality of their lives.   

Another problem with continuing to take these medications for many years may be long term negative side effects.  Negative side effects were reported to some degree in all of the short duration clinical trials, but there is no data on long term negative side effects.  Side effects not initially apparent may surface after continuing to take these medications year after year.

Doctors frequently place patients on AD medications shortly after diagnosis and that's a good option to try to slow down the initial rate of decline.  Adding memantine when the patient advances to moderate stages is also a worthwhile option to sty to slow the rate od decline.  despite an absence of any supportive research, perhaps residual positive effects may even last a year or two for some patients, not just a few months.  But is there any point in continuing these medications beyond two years?  Doctors must be realistic and honest with both patient and caregiver.  Absent research to the contrary, doctors should recommend that their patients discontinue taking these medications after a year or two at the most.

The “Best Buy Drugs Report “ issued by Consumers Union in May, 2012 was not given much publicity until excerpts appeared in the Washington Post on January 7, 2013. ⁹  Consumers Union, which reviewed more than 1100 research studies and articles on AD meds, begins the recommendations section of their comprehensive 2012 report with this statement: “The medications used to treat mental decline in people with Alzheimer’s disease are not particularly effective.  When compared to a placebo, most people who take one will not experience a meaningful benefit.  And it is the rare person who has a significant delay in the worsening of their symptoms over time.” ¹⁰  The recommendations page concludes with these words, “if the person taking the drugs does not show signs of improvement within three months, it is unlikely they ever will, so the drug should then be stopped.” ¹⁰

The Research Center of the Alzheimer’s Association provides much information about treatments for Alzheimer’s.  Their conclusion with respect to current medication is this: “On average, the five approved Alzheimer’s drugs are effective for about six - 12 months for about half of the individuals who take them.” ¹¹

The National Institutes of Health (NIH) also recently affirmed that these AD medications are largely ineffective beyond a limited period of time.  The executive summary of its comprehensive “Alzheimer’s Disease Progress Report,” 2011-2012, concludes that the current FDA approved AD meds “may help some people” ... but even for those it does help, it is ”only for months to a couple of years.” ¹²   

Conclusion

Doctors should definitely prescribe AD medications for several months and even up to a year or two if they or their patients or caregivers see positive effects.  But doctors should not recommend that patients continue taking these medications once they are obviously ineffective.  This practice must stop. 

Doctors must accept that AD medications eventually become expensive “bottles of hope” that will not slow down the inevitable degenerative progression of Alzheimer’s.  Doctors must also accept that, by continuing to prescribe these medications year after year long after they can possibly still be helpful, they may unintentionally be doing their patients and caregivers more harm than good.
 

1.  “Alzheimer’s Disease Medications Fact Sheet.”  NIH, U.S. Department of Health and Human Services.  Accessed online at www.nia.nih.gov/alzheimers/publication/alzheimers-disease-medications-fact-sheet , p. 1. Accessed January 15, 2013, pp. 1-5.

2.  A. Vann.  “Listen More Carefully to Alzheimer’s Caregivers.”  Journal of the American Geriatrics Society, October, 2012, No. 60, p. 2000.

3.  “Cognitive Test in Alzheimer’s Drug Trial May Be Flawed.”  Medical News Today.  Accessed online at www.sciencedaily.com/releases/2012/12/121216200803.htm.

Accessed on December 26, 2012.

4.  “Evaluating Prescription Drugs Used to Treat: Alzheimer’s Disease.”  Consumer Reports, May, 2012, p. 8.  Accessed online at www.consumerreports.org/health/best-buy-drugs/alzheimers.htm.  Accessed on January 15, 2013.   

5.  Razadyne ... “Full U.S. Prescribing Information.”  Accessed online at www.razadyneer.com/sites/default/files/shared/pi/razadyne_er.pdf, pp.2-4.  Accessed on January 15, 2013

6. “Exelon ... “Highlights of Prescribing Information.”  Accessed online at www.pharma.us.novartis.com/product/pi/pdf/exelon.pdf, pp. 13-16.  Accessed on January 15, 2013.

7. “Aricept ... Highlights of Prescribing Information.” Accessed online at www.aricept.com/assets/pdf/AriceptComboFullPIFebruary2012.pdf, pp. 7-11.  Accessed on February 5, 2013.

8. “Namenda Full Prescribing Information.”  Accessed online at www.frx.com/pi/namenda_pi.pdf,  pp.3-8.  Accessed on January 15, 2013.

9.  “Alzheimer’s drugs are expensive and don’t work very well for most people.”  Accessed online at www.washingtonpost.com/national/health-science/alzheimers-drugs-are-expensive-and-they-dont-work-very-well-for-most-people.  Accessed on January 7, 2013.

10.  “Evaluating Prescription Drugs Used to Treat: Alzheimer’s Disease.”  Consumer Reports, May, 2012, p. 3.

11.  “Five FDA Approved Alzheimer’s Drugs.”  Research Center, Science & Progress Treatment Horizon section.  Accessed online at www.alz.org/research/science/alzheimers_disease_treatments.asp. Accessed on January 15, 2013.

12.  “A Primer on Alzheimer’s Disease and the Brain.”  NIH Alzheimer’s Disease Progress Report, 2011-2012, p. 9.  Accessed online at www.nia.nih.gov/alzheimers/publication/2011-2012-alzheimers-disease-progress-report/primer-alzheimers-disease-and.   Accessed on January 15, 2013.

Published in JAMDA, Journal of the American Medical Association, July, 2013, Vol. 14, No. 7 pp. 525-527.  Access at: www.jamda.com/article/S1525-8610(13)00167-9/fulltext
 

Alzheimer's Behaviors or Coincidences?

My wife, Clare, has Alzheimer’s Disease (AD). I have lived with Clare’s Alzheimer’s for seven years … three years observing symptoms prior to her diagnosis and four years since her diagnosis in 2009, a month after she turned 63.  Except for a few hours of respite time each week, I am with Clare, 24/7.  Caregivers for AD spouses living at home often notice AD behaviors that doctors may not observe during routine office visits, and sometimes we observe behaviors not reported in any AD books or research.  Perhaps researchers should give closer attention to our collective observations in an attempt to diagnose or treat AD more effectively.

1.  Brief periods of “awakening”

Many in my spouse support groups note that our spouses often demonstrate brief “awakenings” when they seem to exhibit no “brain fog” for a period of time.  Even on their foggiest days, our spouses sometimes have brief periods of perfect lucidity.  This aspect of Alzheimer’s is noted in the professional literature.  What is not found in the literature, however, is that many caregivers notice that such awakenings occur most frequently during doctor visits.  When that happens, our reports of worrisome behaviors are often dismissed or ignored because doctors themselves see no evidence of such behaviors.  We also often see awakenings when our spouses are with close relatives and friends. 

Why do our spouses sometimes fail to demonstrate many of their routine AD behaviors in the presence of their doctors, close relatives, and friends?  Is it due to a very strong denial instinct that enables them to mask their symptoms and override AD behaviors for a brief period of time?  Is it due to a strong subconscious desire to appear well in front of their doctors, close relatives, and friends?  Is it possible that some people with AD can have denial instincts or subconscious thoughts so strong that they can stimulate the release of certain chemicals in their brains to cause a brief awakening?  If so, could a medication be devised to stimulate similar brain activity that could, perhaps, diminish some AD symptoms even if only for brief periods of time?  All I know for sure is that every member of my spouse support group observes these brief awakenings most frequently in the presence of doctors, and also often when in the presence of close friends and family.  Why?

 

2. Forgetting to brush teeth
My support group is for spouses of people with early to moderate stage AD.  We have commented several times about how the first personal hygiene habit that our spouses seem to forget is the daily brushing of their teeth.  Some of our spouses are incontinent.  Some are not.  Some go to bathrooms by themselves.  Some cannot.  Some bathe or shower, shave or groom, all without difficulty.  Some cannot.  Some dress themselves.  Some cannot.  But all seem to need daily reminders to brush their teeth.  After such reminders, some will brush their teeth fine by themselves while others still require some assistance.  Many who cannot remember to brush their teeth without prompting can handle much more complicated personal hygiene tasks without any prompting whatsoever.  For example, Clare still remembers how to insert/remove her daily contact lenses properly by herself and see to their daily maintenance. 

Is brushing one’s teeth a habit so easily forgotten because of the repetitive physical motion of the act of brushing?  Is it because brushing one’s teeth is one of the earliest learned personal hygiene behaviors, so it is the first to be forgotten?  Is it because multiple steps are involved … locate the brush, locate the toothpaste, open the cap and squeeze just the right amount of toothpaste onto the brush, etc.?  All I know for sure is that every member of my spouse support group said that brushing their teeth was the first personal hygiene behavior our spouses had forgotten.  Why? 

3. Sleeping diagonally in bed

With few exceptions, people in my support group still sleep in the same bed with their spouses, and those who do have all reported that our spouses lie diagonally across our beds when sleeping, crossing into our own personal “bed space.”  Our spouses all start off sleeping on their sides of the bed … but, slowly but surely, during the night they end up sleeping diagonally across the bed. 

Is this due to some sort of psychological need for our spouses to remain physically close to us even while asleep, much as many people with AD “shadow” their spouses when awake?  We all report how our spouses often follow us into another room just to remain close to us.  Is sleeping diagonally their way of using us as their security blankets in bed at night?  Is this a neurological reaction to something?  Is this due to loss of orientation of their body in space? All I know for sure is that many members of my spouse support group have said that their spouses sleep diagonally across their beds.  Why?

 

4. Dreaming and sleep talking
Although Clare is already in moderate stages of AD, she remains highly verbal despite increasing episodes of aphasia.  Perhaps that is due her strong language background as a former high school teacher of English, English as a Second Language, and Spanish.  Perhaps this is simply the course her disease is taking.  However, as Clare’s memory and executive functioning skills have declined over time, she has begun a new behavior that is getting “stronger” … dreaming and talking aloud in her sleep. 

Prior to her AD diagnosis, Clare often commented to me about how she never remembered having had any dreams.  Although Clare still has no memory of any dreams, I cannot sleep through even one night anymore without being awakened several times by her sleep talking!  Prior to her AD diagnosis, whereas she may or may not have been having many dreams each night, she had never talked aloud in her sleep!  Her sleep talking began about two years after diagnosis.  At first, she only expressed a few softly mumbled words and then her mumbling evolved into a few quiet sentences.  After several months, however, this sleep talking has progressed to clearly spoken conversations, albeit only the one sided dialogue that I hear.  This dialogue is now routinely accompanied by hand gestures, laughing, crying, singing, whispering, or shouting … all dependent, I suppose, on the nature of Clare’s particular dreams at the time.  She even occasionally appears to be conducting a choir or orchestra in her sleep! 

What I find most fascinating is that I have yet to detect any instances of aphasia when Clare is sleep talking.  Sentence after sentence is spoken clearly, with no hesitation in her speaking aloud to “find” words that she otherwise “loses” when she is awake.  This observation of fluent sleep talking, and the way it has progressed over time, is a pattern also observed by several others in my support group.  Not by all members … but by several … and for those who have observed it, the pattern is identical.  Each of us first observed the quiet mumbling of a few words expand into quietly spoken sentences and then into clearly spoken sentences and dialogue … and always completely fluent with no episodes of aphasia.  For some people with AD, is sleep talking itself an indicator of something else?  For those with AD who do sleep talk, is the lack of aphasia episodes during their sleep talking indicative of something that can eventually be helpful with additional research?  All I know for sure is that several members of my group whose spouses are also aphasic report no instances of aphasia during their spouses’ sleep talking.  Why?

So what does this all mean?

Perhaps these four observations … when awakenings seem to occur most often, forgetting to brush one’s teeth, sleeping diagonally in bed, and sleep talking … should be dismissed as “interesting“ but relatively meaningless observations  of a group of spouse caregivers.  Perhaps none of these four behaviors are related to Alzheimer’s.  But … perhaps one or more of these four behaviors are related to Alzheimer’s and have simply not been studied because researchers have not been made aware of them.

A recent study conducted with mice by researchers at Washington University School of Medicine in St. Louis reported that sleep problems may be among the earliest indicators of Alzheimer’s.  Senior author David M. Holtzman, head of Washington University’s Department of Neurology, stated: “If these sleep problems exist, we don’t yet know exactly what form they take – reduced sleep overall or trouble staying asleep or something else entirely.  But we’re working to find out.”  (Roh JH, Huang Y, Bero AW et al.  Disruption of the sleep-wake cycle and diurnal fluctuation of amyloid-b in mice with Alzheimer’s disease pathology.  Science Translational Medicine 2012; 4:150fs34.  Summary of article accessed online, September 5, 2012.)

Perhaps “something else entirely” could be sleeping diagonally in bed.  Or, perhaps, “something else entirely” could be sleep talking.  All I know is that when a group of caregivers whose spouses range in age from the early 60s to the late 80s all report similar or identical observations that are not mentioned in the professional literature, it stretches belief to simply dismiss all such observations as coincidences.  When we can learn nothing about these observations from our doctors or from the professional literature, and we hear nothing about similar observations from friends who are not dealing with a spouse with Alzheimer’s, we are left with one simple question:  Why?

Published in Journal of Alzheimer's Disease and Parkinsonism, May, 2013, Vol. 3, No. 1, pp. 111-112.  Access at: www.omicsonline.org/2161-0460/2161-0460-3-111.php?aid=14346