Personal Blog #32 … New AD Medication, Leqembi (Lecanemab), Receives FDA Approval and Coverage Under Medicare … 7/6/23

 

The U.S. Food and Drug administration (FDA) gave full approval today for Japanese drugmaker Eisai, and its American partner, Biogen, to market its latest medication, lecanemab (to be known as Leqembi) for those with mild Alzheimer’s disease (AD).  According to Teresa Buracchio, acting director of the Office of Neuroscience in the FDA's Center for Drug Evaluation and Research, “Today's action is the first verification that a drug targeting the underlying disease process of Alzheimer's disease has shown clinical benefit in this devastating disease." 

Six months ago the FDA gave conditional approval for this new medication, but there was much debate in the medical community about the effectiveness demonstrated by its data.  Medicare said it would not pay for routine use of Leqembi until the FDA gave its full approval.  Today the FDA has given its full approval.  The FDA acknowledged that after an 18-month clinical trial with 1800 participants, results showed that those taking the new medication showed a significant difference on an 18-point scale measuring cognitive functioning and memory.  According to FDA, this study showed that Leqembi “slowed memory and cognitive decline by about 5 months for those receiving the medication as opposed to those receiving the placebo.”

A doctor quoted this afternoon in a USA Today article said, “This drug is not a cure. It doesn't stop people from getting worse, but it does measurably slow the progression of the disease. That might mean someone could have an extra six months to a year of being able to drive."  A doctor quoted this afternoon in The New York Times stated, “The risks are very vivid.  Within the first few months, you may have small bleeds or swelling in your brain, which may or may not be symptomatic and if not detected in time can cause disability.”

The FDA indicated that Leqembi will carry a” black-box warning” about possible side effects such as brain swelling and bleeding. The warning does not mention patients who are taking blood thinners, but Leqembi’s label says that “additional caution should be exercised” when considering whether to give blood thinners to Leqembi patients.  As also noted in The New York Times article, “Concerns about safety have been stoked by reports of deaths of three clinical trial participants who experienced brain swelling and brain bleeding, two of whom were being treated with blood thinners. Eisai has said it is unclear if Leqembi contributed to their deaths because the patients had complex medical issues.“

 

In my Personal Blog #28, I noted that ”17% of the patients taking this medication suffered cerebral micro and macro hemorrhages and superficial siderosis compared to 8.7% in the placebo group.”  I also shared my feelings in PB #28 about medications yielding “statistical differences,” noting that although statistically significant those differences might not result in “real world” differences.

This new IV medication is priced at about $26,500 for a year’s supply of injections that are to be given every 2 weeks and Medicare will now cover about 80% of its costs.  This still leaves patients with 20% of the cost, plus other related expenses for doctor visits, required scans, etc.  Personally, I’d prefer that Medicare spend its money more wisely than subsidizing patients taking this new medication.  And I think patients can better spend their money on support groups, saving for the future when home health aides or assisted living or nursing home facilities may be needed, or for other present expenses or future costs.

So what is my take on this FDA approval of Leqembi?  Whereas I am truly pleased that we now have a medication that has shown it may be able to slow cognitive decline and memory loss by up to 5 months in an 18-month period of real time, I don’t think my late wife would have considered taking such a medication.  Why?  Three reasons:

First, getting IV injections every 2 weeks for a year would have been a very stressful experience.  Just getting ready to go and driving to and from the doctor’s office to receive IV injections twice a month would have been stressful.  In addition, my wife always felt pain with injections, bled easily, and her skin turned all pretty colors whenever receiving a needle for any reason … possibly due to all the heavy-duty heart medications she took each day, including 325 mg of daily aspirin.  Even had my wife  started this medication, I don’t think she would have continued for too long. Those IV needles would have been painful as well as stressful.

A second reason is the side effects.  AD is serious enough as it is, a death sentence with no cure and the 100% certitude of worsening conditions.  Gaining a few additional months of time to continue leading a more “normal” life before cognitive and memory issues worsen even more would be wonderful … but what a heavy price if those side effects occurred.  Dealing with AD and heart disease was enough of a double whammy for my wife.  Possibly compounding that with brain swelling, bleeding, headaches, etc. due to this medication could have made her situation even worse than it already was

The final reason is the real world “effectiveness” of this new medication.  Study participants taking the medication showed a gain of less than one half of one point on testing … a statistically significant outcome, perhaps, but I question how much of a clinical difference that difference would have really made in my wife’s life or in mine.  As that doctor quoted in The New York Times noted with respect to the slowing of decline with Leqembi, “The benefits of slowing are subtle. You’re not going to experience the perception of changes in your cognition or function in the same amount of time.”  As I noted in PB #28, not all studies demonstrating results showing “statistical differences” in testing translate into meaningful and/or observable differences in the real world.

By the time my wife was in early stages of AD, our lives had already changed dramatically.  A few more months of slower decline would have been welcome, but would probably not have changed much about our daily lives.  Especially when one considers that the trade-off to perhaps gaining a few months of slower decline might have led to losing the quality of life we still had.  Slowing decline doesn’t mean ending it and we may not have even noticed that slowing.  The added stress of two more doctor visits each month, the pain and after-effects of IV needles, and possible additional pain or hospitalization due to severe side effects of this new medication could have easily lessened whatever quality of life we still had.

So what is my bottom line reaction to this FDA approval of Leqembi?  It is this:  Would I have loved my wife to have declined at a slower rate for a few more months in those early stages?  Of course.  Would I have loved to have taken more trips with her? Absolutely.  But worrying about the possibility of her having a serious brain hemorrhage or other serious side-effect while traveling away from home would have worried me too much to have taken that chance. In fact, I would have been worried every single day, whether at home or not, had she been taking this new medication.

I haven’t even mentioned another real word effect of this new medication … the demands place upon the care partner of having to bring the AD patient to and from doctor appointments.  Even in early stages, AD patients may need assistance in dressing, mobility, may object to going out in bad weather or going out at a certain time of day, etc.   In addition, many care partners of AD patients are still working when their loved ones are in early stages, and time demands of taking loved ones to two visits each month for IV injections could be an additional burden for them as well.

So whereas I am truly pleased to welcome a new medication to try to help those with AD, I would not have found Leqembi worth the risk. 

Personal Blog #31 … Donanemab, a Proposed New AD Medication … 5/8/23

 

I debated whether or not to even write this blog offering my opinion about donanemab.  Last week there was yet another big pharma announcement of clinical trial data for a new medication as an effective treatment for those in early stages of Alzheimer’s disease (AD) … donanemab.  No one wants more than I do to learn about new effective treatments for those in any stage of AD.  However, I have been disappointed too many times by big pharma companies releasing announcements of positive clinical trial results without simultaneous disclosure of all supporting data and peer review commentary.  Early announcements of rosy results have too often overplayed the positive effects of new medications and too often downplayed serious negative side effects.  I fear that donanemab is just the latest AD medication that a big pharma company has touted as having promising results that are “statistically” significant but not really “clinically” significant, and with extremely dangerous side effects.  (Please see PB # 28, posted on 10/4/22, about my serious doubts about the “significant” published results and dangerous negative side effects of lecanemab (now sold under the brand name, Leqembi), last year’s new AD medication from Eisai and Biogen.  In that blog I also discuss how statistically significant differences in AD testing for new meds may be totally insignificant and meaningless with respect to functioning in the real world.)

According to an article published in Nature on May 4, “For the second time, an experimental drug has been shown to reduce the cognitive decline associated with Alzheimer’s disease. On May 3, pharmaceutical company Eli Lilly announced in a press release that its monoclonal antibody donanemab slowed mental decline by 35% for some participants in a 1,736-person trial — a rate comparable to that for competitor drug lecanemab.”  Lilly said it intends to seek FDA approval within the next month or two, will issue further results at a major AD conference in July, and seek publication of its data in a forthcoming peer reviewed journal.

Early reactions to this announcement have been mixed.  According to that same Nature article, “Researchers warn that until the full results are published, questions remain as to the drug’s clinical usefulness, as well as whether the modest benefit outweighs the risk of harmful side effects.  Some researchers who have reviewed the limited data released to date are doubtful of its effectiveness.”  Quoting Dr. Marsel Mesulam, a neurologist at Northwestern University, “The results that are described are extremely significant and impressive, but clinically their significance is doubtful.”

As reported in the May 3 NY Times article about donanemab, “24 percent of patients had the side effect of brain swelling and bleeding, and 6 percent had symptoms like dizziness, headache or fainting. Three patients in the Lilly trial died.  The company reported that two to three out of 10 patients taking donanemab progressed (to worsening stages of AD) over the next 18 months, compared to the expected three to four patients taking a placebo.” Lilly said that people with mild Alzheimer’s who received donanemab “showed 35% less clinical decline over 18 months than did those who received a placebo, and 40% less decline in their ability to perform daily tasks.”

According to the NY Times piece, Dr. Ronald Petersen, Mayo Clinic’s director of the Alzheimer’s Disease Research Center, said that “the donanemab results were modest but meaningful adding that  “patients and their families must be counseled about a dire side effect of donanemab - a risk of brain swelling that can result in death.”  Dr. Samuel Gandy, professor of Alzheimer’s disease research at Mount Sinai, noted that whereas the results for both lecanemab and donanemab were reported to be statistically meaningful, they have “only modest clinical benefit.” 

In an article about donanemab published in Science on May 3, the author wrote: “We cannot be sure that this drug will actually make a difference in the real-world care of patients with Alzheimer’s - not yet, anyway. This point is completely avoided in the Lilly press release, but it is nonetheless real and we will be hearing more about it from clinicians - well, if you listen closely above all the noise, that is.” Also noted is how the negative side effects in the donanemab trial were worse than those in the lecanemab trial.  For lecanemab, “the reported rates of ARIA-E and ARIA-H (measures of brain bleeds) were 13% and 17% of the trial participants, and the rates in this new donanemab trial were noticeably higher: 24% and 31%.”  That same article quoted a tweet from Dr. Robert Howard, a psychiatrist at University College London who has tested treatments for dementia.  Howard tweeted, “Looks as dangerous as lecanemab.”

I remain very skeptical while awaiting full data and peer review of results from Lilly’s new proposed medication, donanemab … and for the same reasons as noted in my PB #28 about lecanemab.  Here’s why: When my wife was diagnosed with early onset AD, we knew that most people, on average, progress through the stages of AD in about 8 years … some more quickly, some more slowly.  We thought that we could be reasonably confident of having at least 3 and maybe even 4 more really good years together before she would progress to moderate stages of AD.  And we did.  During those first few years after diagnosis, we traveled extensively both in this country and internationally.  We played our favorite word games like Scrabble and Boggle, continued to go bowling in our leagues, enjoyed going out by ourselves and with friends to see plays and movies, and enjoyed just sitting on a bench at the water’s edge on nice days. We had a very rewarding life together for those first three to four years after diagnosis.

Had a medication such as lecanemab or donanemab been available, would we have risked what turned out to be nearly four really good years together to take medication hoping my wife would be in the 35% of those who might gain an extra few good months, but all the while risking that she could be in the group of 24% who would suffer brain swelling or brain bleeds, stroke or death?  I think not. There is just too much downside risk, in my opinion … the high risk of negative side effects of this new medication simply outweigh any hope that there may be a slight reduction in the rate of decline for a few more months.  I await the published results and peer review of this new proposed medication later this summer or fall, but I am not very optimistic.

Personal Blog #30 … Medicare Quality Measures, Part II … 2/11/23

 

In my column posted on 11/4/22 … PB #29, “Medicare Quality Measures, Part l” … I wrote about a “quest” I was on to see if Medicare would consider making a doctor’s referral of an AD patient or caregiver to a support group qualify as a “quality measure.”  To briefly review, in response to my June article about support groups, a doctor had suggested that more doctors might refer AD patients and caregivers to support groups if referrals were considered Medicare “quality measures” … actions that would result in financial or other incentives for doctors to make such referrals.  I then described my unsuccessful efforts to reach someone at CMS … Centers for Medicare and Medicaid Services … who could give me information about this matter.  No email address was available for the head of CMS, Chiquita Brooks-LaSure, and no one contacted at CMS would give me her email address.

In late December, tired of waiting for a response from Medicare administrators I was able to email, I decided to try a hunch and sent an email to the head of CMS by using the same ID characteristics of email addresses for the lower level CMS administrators … first and last names or initials with periods and such, followed by the CMS email string of cms.hhs.gov.  Much to my surprise, within one day I received a detailed response from a high ranking CMS official who said my email to Brooks-LaSure was referred to him.  Aside from being very helpful, the official also provided me with websites to find additional information and wrote, in part:

“I directed your most recent email to our group of experts on quality measures, called the Quality Measurement and Value-Based Incentives Group (QMVIG) within the Center for Clinical Standards and Quality (CCSQ). You have definitely gotten to the right place to make sure your input is being submitted and that you’re getting the information from the best source.  I checked before I left for the holiday last week, and they were about to get back to you.  So you should hear from them soon.  I’ll follow up there again, and I’m sure they will respond back more fully with more robust information but … there are potentially payment incentives for our quality programs.”

I was very excited with this response and followed up by reading information on websites provided by the senior advisor.  However, a month went by with no response from QMVIG, so I wrote again to the CMS official in Ms. Brooks-LaSure’s office.  Within 48 hours I received a detailed response from an administrator of QMVIG.  Here are excerpts of that response to my email, specifically to three questions I raised:

“1. Would there be a specific billing or reimbursement advantage for doctors who would report using such a Medicare quality measure?  Potentially. Quality measures are commonly used in quality reporting programs or value based purchasing programs which seek to revise our payment systems by focusing on high value care (high quality/low cost). Depending upon the care setting, a program may apply penalties or bonuses based on provider performance on quality metrics. Some areas where Medicare does have payment is on caregiver health risk assessment through CPT code 96161. Additionally, through Medicare’s cognitive assessment and care plan services CPT code 99483, clinicians can refer people with suspected or diagnosed dementia to social services (such as support groups) and determine caregiver willingness to furnish care: https://www.cms.gov/files/document/cognitive-assessment-care-plan-services-cpt-code-99483.pdf

2. Would there be any other specific advantage to doctors who would report using such a Medicare quality measure? Other advantages include the ability to share performance information on measures with the public, which can be used as consumer tools when selecting a provider and leveraging results of quality measurement to identify areas where there is room for quality care improvement.

3. If the answer to questions 1 and/or 2 is yes, what would be my next step in trying to have Medicare consider AD support group referrals as "quality measures." It is a long process to have something be considered for a quality measure, and usually involves having a measure developer who has experience developing a measure – as quality measures used in federal programs require strict definitions, specifications, and testing for validity and reliability. However any measure by any developer may be submitted to CMS for consideration. Please see the Measure Blueprint for more information on this process (https://mmshub.cms.gov/blueprint-measure-lifecycle-overview). The measure would then be submitted to a consensus-based entity for endorsement, such as the National Quality Forum (https://www.qualityforum.org/what_we_do.aspx). The measure ultimately needs to be submitted to the Measures Under Consideration list. Information on the pre-rulemaking process can be found here https://mmshub.cms.gov/Pre-Rulemaking-Resources.”

My initial response to this administrator’s email, which also included a lot more relevant information, was that the CMS bureaucratic process for something to become a Medicare “quality measure” was a navigational process beyond my capabilities.  After checking out the websites and familiarizing myself more with the bureaucratic hoops I’d have to go through to make my quest successful, my initial response was confirmed.  I emailed the QMVIG administrator telling her that I now planned to contact an advocacy organization with the resources and expertise to deal with the CMS bureaucracy …perhaps AARP, The Alzheimer’s Association, or UsAgainstAlzheimer’s … since, as the administrator noted, “it is a long process to have something be considered for a quality measure, and usually involves having a measure developer who has experience developing a measure.”  My experience with educational and non-profit organizations is that they almost always hire or already have on staff one or more specialized individuals with the precise experience necessary in order to apply for state or federal grants in their field, and this quality measure quest seems to be much like a state or federal  grant application process.  I would expect a large AD advocacy organization to have people with such experience.

I plan to forward what I have learned to one or more AD advocacy organizations and hope one of them will pursue this quest to have CMS recognize doctor referrals to AD support groups as quality measures.  Then, perhaps, more people with AD and their caregivers will learn more about support groups and benefit from attending such groups.

Personal Blog #29 … Medicare Quality Measures, Part I … 11/4/22

 A doctor who read my June article, “Alzheimer’s Disease Support Groups,” suggested that if a support group referral could be declared a “quality measure” by Medicare, perhaps more doctors would discuss the importance of AD support groups and where their AD patients and caregivers could find them. 

I decided to follow up to learn more about Medicare “quality measures” and, specifically, to find out if more doctors might refer AD patients and caregivers to AD support groups if such referrals were considered “quality measures.”

My interaction with the Medicare bureaucracy began with a Google search.  I Googled the question, “Who is in charge of Medicare?” hoping to learn who I could email to find out more about quality measures.  The main Medicare website, cms.gov, states that “The Centers for Medicare & Medicaid Services (CMS) is the federal agency that runs the Medicare Program.  CMS is a branch of the Department of Health & Human Services (HHS).”  However, that site did not provide me with any email addresses.

I next Googled, “Who is the administrator in charge of Medicare?”  The first item that popped up was the name (and picture) of the person in charge and I read her biography on that site.  Chiquita Brooks-LaSure is the “Administrator for the Centers for Medicare and Medicaid Services (CMS).”  The site noted that LaSure has oversight responsibilities for many programs, including “Medicare, Medicaid, the Children's Health Insurance Program (CHIP), and the HealthCare.gov health insurance marketplace.”

Very helpful information, but I could not find an email address for LaSure at that or any other CMS site.  However, the cms.gov site, did provide brief biographies for the other three top Medicare administrators … the Principal Deputy Administrator & Chief Operating Officer, the Chief of Staff, and the Deputy Chief Operating Officer.  Only the Deputy Chief Operating Officer provided an email address, so I sent an email to Karen Jackson, Deputy Chief Operating Officer.  According to information on the cms.gov site, Jackson “provides executive leadership for CMS’s mission support functions …”

After a month passed and I still had received no response to my email, I searched to find another email address for someone who could answer my question, but found none.  Eventually, I ended up in an “online chat” with a helpful person, Brittany, at cms.gov.  Brittany placed me on hold several times to search for an email address, but she was unable to provide me with any email address for a top administrator other than for Jackson.  I told Brittany that surely there must be SOMEONE in the entire Medicare bureaucracy responsible for replying to emails from the public, but she was unable to find anyone else.

At that point, however, Brittany provided me with a helpful lead by referring me to another CMS agency, the “Quality Improvement Organization (QIO) Program.”  When I went to the QIO program page on the cms.gov site, I found this information: “The QIO Program, one of the largest federal programs dedicated to improving health quality for Medicare beneficiaries, is an integral part of the U.S. Department of Health and Human (HHS) Services' National Quality Strategy for providing better care and better health at lower cost. By law, the mission of the QIO Program is to improve the effectiveness, efficiency, economy, and quality of services delivered to Medicare beneficiaries.”

I sent off an email to that QIO email address that basically restated my email to Karen Jackson a month earlier:

-------------------------

I am hoping that you can help me. I am a former Alzheimer's disease (AD) spouse caregiver and I write frequently for publication about AD issues to help raise awareness and to help other caregivers. In one of my recent articles, I wrote about a problem that existed a dozen years ago and continues to exist today ... too many doctors do not alert AD patients and caregivers to the availability and helpfulness of local support groups.

A doctor who read my article said that if an AD support group referral were to be considered a Medicare "quality measure," perhaps more doctors would inform their patients and caregivers about how helpful support groups can be.  Based upon that doctor's comment, I have 2 questions:

 1. Is there a billing or reimbursement advantage for doctors who report using Medicare quality measures?

2. Is there any other advantage to doctors who use Medicare quality measures?  If a support group referral could become a "quality measure" that might lead to more AD patients and/or their caregivers seeking out such groups, what steps can I take to have Medicare consider such referrals as "quality measures."

 Thank you for your time and consideration.

---------------------------

Hopefully there will be a Part II to this blog with a response from someone at QIO about Medicare quality measures, and if AD support groups discussions/referrals could become quality measures.  It is truly a shame that so many people with AD and their caregivers are unaware of the existence of support groups and how helpful such groups can be on their AD journey.  Whereas there are many more support groups today than there were back in 2009 when I first sought such groups, doctors today are still not routinely referring their AD patients and caregivers to support groups.  Maybe, just maybe, that doctor who commented to me about my article was right … maybe, just maybe, more doctors would make their AD patients and caregivers aware of such groups if doing so were considered a quality measure by Medicare.  Stay tuned!

 

Personal Blog # 28 … Lecanemab … Promising New Effective AD Medication, or Just another Disappointment? … 10/4/22

 According to an article in The Washington Post on 9/27/22, “An experimental Alzheimer’s drug (Lecanemab) slowed cognitive and functional decline by 27 percent in a closely watched clinical trial.  Japanese drugmaker Eisai and its American partner, Biogen, said the slowing of deterioration, compared with a placebo, was “highly statistically significant.”

The Phase 3 clinical trial, called Clarity AD, had1795 participants with mild cognitive impairment caused by Alzheimer’s or early-stage Alzheimer’s and “demonstrated that lecanemab reduces abnormal clumps of beta amyloid, a hallmark of Alzheimer’s.”  The article went on to say that “Eisai, which is taking the lead in developing the drug and working with regulatory authorities, will present the full results of the study in late November at an Alzheimer’s conference in San Francisco. The results also will be published in a medical journal.”

 

As of today, there has been neither peer review nor publication of the results reported.

 

“Officials said the clinical trial participants were tested in several areas to gauge the pace of their decline, including memory, orientation and problem solving.  Starting at six months, the companies said, the group that received the treatment did better than the placebo group. The treatment was administered intravenously twice a month.

The lecanemab group experienced side effects including brain swelling and bleeding — complications of anti-amyloid therapies — but the rates were within expectations, the companies said in the release.” 

 

That range of serious adverse side effects, not reported in this Post article but available on the Biogen website, noted that 17% of the patients taking this medication suffered cerebral micro and macro hemorrhages and superficial siderosis compared to 8.7% in the placebo group.  (See posting on Biogen website entitled, “Lecanemab Confirmatory Phase 3 Clarity AD Study Met Primary Endpoint …” 9/27/22.)

 

Until this clinical trial data undergoes peer review, we can only hope that despite almost double the rate of serious negative outcomes, this medication may prove to be helpful for some patients with MCI or those in early stages of AD.  Sadly, too often in the past there have been early claims made about favorable outcomes with proposed new AD medication that did not stand up to scientific scrutiny.  Also, some studies have yielded “statistically significant” results on tests that did not really make much difference in the “real world” lives of those with AD … test results that were statistically significant but not clinically significant.

 

As a former 24/7 AD spouse caregiver, I often think of “statistically significant” AD test results in this way:  Suppose one has 2000 equally healthy and robust house plants, each having 100 healthy leaves, with each plant expected to live for one full year before losing all of its healthy leaves.  A clinical trial is conducted to test whether or not a chemical added to “enrich” the water is better than just plain water for these plants.  For the next year, 1000 plants receive regular water and 1000 plants receive the “enriched” water.  After one year, the plants receiving enriched water have 96 or more dead leaves, while the plants receiving only regular water have 98 or more dead leaves.  If that study then concluded that the difference in dead leaves is statistically significant, those results would be totally meaningless to me.  The bottom line is one would have two dead plants!  The plant with “only” 96 dead leaves would not look appreciably healthier than the plant with 98 dead leaves. 

 

In other words, there is “statistical” significance and there is “clinical” difference.  I am hoping for the day when a new AD medication will prove clinically effective in the “real world,” meaning that there will be a positive consequential difference in the lives of those with AD … a much longer time before symptoms develop or worsen, or complete disappearance of some symptoms, let alone cure this horrible disease.

 

Until the clinical trial data on lecanemab is subject to peer review and critically examined to demonstrate that there are meaningful positive differences in the lives of clinical trial participants who took this medication, I won’t let myself get too excited.  Not just yet.  I have been disappointed too many times.  I have seen too many dead plants.

 

 

 

 

PB #27 ... Articles About GEAR Program Now Available to Everyone ... 8/31/22

Readers familiar with this site will note that I have already posted several Personal Blog columns about the GEAR program … Blogs # 18, 24, and 26 … a federally funded program designed to improve care for people with Alzheimer’s disease (AD) and other forms of dementia in hospital Emergency Departments (EDs).  Published manuscripts about the research reviews conducted by the GEAR task force in four focus areas … communication, detection, best practices, and transitions … are now available to read.  These articles, as well as additional information about this project, may be accessed in the “Manuscripts and Publications” section of the main GEAR website at https://gearnetwork.org.

In the words of Dr. Chris Carpenter, one of the leaders of this project, “We would like to generate some media interest in this effort so that persons living with dementia and their care partners are aware of this work.  The more folks know the more they can pressure their Congressional leaders to ensure funding for this research. These citizens can also pressure their local emergency departments to begin adapting for more dementia-friendly care.”

If any reader has access to major mass media, it would be wonderful to alert such media to the availability of these manuscripts to generate more interest in improving emergency care for dementia patients and increase general awareness of what must be done.  Following are the verbatim “Conclusions and Implications” sections of the manuscripts dealing with our four areas of focus.  It is hoped that these articles will lead to future research to develop the most effective strategies in each area and eventually lead to substantial improvement in how dementia patients are treated in hospital EDs.

  

Communication … Conclusions and Implications

This scoping review identified sparse published research to guide evidence-based communication strategies in the ED for PLWD and their care partners. Although general themes appear to emerge around rushed communication and inadequate engagement of care partners, these findings are neither quantified nor directly linked to ineffective communication. Strategies to improve ED communication for PLWD do not exist, although educational interventions outside the ED suggest limited effectiveness. GEAR 2.0-ADC stakeholders prioritized the identification of barriers and facilitators to effective ED communication for PLWD.

 

Detection … Conclusion and Implications

We report the results of 2 systematic scoping reviews evaluating diagnostic accuracy and feasibility to detect cognitive impairment and dementia in the ED setting. The GEAR 2.0 Advancing Dementia Care task force, using these results, developed consensus research priorities practice gaps to advance the detection of cognitive impairment and dementia in the ED setting. They include the need for more effective and efficient approaches to recognize persons at risk for cognitive impairment and dementia. These approaches should balance the importance of equitable screening and the goal and the consequences identifying cognitive impairment. These research priorities will be the basis of future GEAR 2.0 research funding opportunities.

 

Best Practices … Conclusions and Implications

The results of this scoping review reveal a wide range of components of both ED care practices and ED care needs for PLWDs. Although many structural and process interventions show positive results, the lack of depth and reproducible results prevent specific recommendations on best practices in ED care for PLWDs. Future research should work to identify improvements in ED care for PLWDs, address gaps in training, identify priority outcomes, address community and identity-based factors, and incorporate economic viability and implementation science

Transitions … Conclusions and Implications

This systematic scoping review found few ED-to-community care transition interventions targeting cognitively impaired older adults and their care partners. Further, there was little data identifying care transition outcomes of importance to these groups. Personalizing care transitions for these ED patients and measuring what matters most during ED-to-community care transitions were identified as the highest priority areas for future ED research involving cognitively impaired older adults and their care partners. As such, research funding agencies, advocacy groups, and researchers should focus their resources and efforts on these domains, thereby developing the science to improve the health of this vulnerable population.

 

Once again, readers are urged to access https://gearnetwork.org to read the entire articles and learn more about this project.

Alzheimer Disease Support Groups

 

JUNE 2022 PRACTICAL NEUROLOGY 45

 Alzheimer Disease Support Groups

A care partner plea for physicians to inform patients and care partners about Alzheimer disease support groups.

By Allan S. Vann

 

 

 

   I am a retired public school principal. I started observing my late wife’s symptoms of what would eventually be diagnosed as early or young-onset Alzheimer disease (AD) 15 years ago. There were many frustrations, especially about misdiagnoses for several years. As my wife was treated first for stress, then anxiety, and then depression, I continued seeing her AD symptoms worsen. Another frustration was that we were not informed about available support groups, which led me to become an advo­cate and share my frustrations in written publications.

   In my first article, published in the American Journal of Alzheimer’s Disease and Other Dementias in 2010, I noted the need for doctors to be more helpful in finding sup­port groups for their patients, “Doctors as well as local/ national AD organizations should also be working together to provide patients with ready access to support groups as patients progress through the stages of this fatal dis­ease—and helping to better meet the needs of those who are diagnosed at a young age and/or are in the very early stages of the disease.”¹

 

My Support Group Experience

   At the time of my wife’s diagnosis, I could not find a sin­gle support group on Long Island specifically designed for those with early onset AD. I did find a group for people in early-to-moderate stages of AD, and my wife was accepted into that group. The Long Island Alzheimer’s and Dementia Center also had a support group for spouses of people with AD, but I didn’t think that I needed a support group at the time. I was so focused on my wife’s needs that I hadn’t yet begun to understand what my needs were, or would be, as her disease progressed.

  My wife, however, insisted that she would only join her support group if I attended at least 1 meeting of the spouse’s support group. So, as she went to meet with her group, I went to what I thought would be my only meeting with the spouse’s support group. To my surprise, within minutes, I realized that group was where I needed to be. My wife’s insistence may have been her final gift to me because I don’t know how I would have coped during her illness without assistance from that spouse’s group. I was too naive back then to realize that support groups for AD care partners may be even more important than support groups for those with AD.

  I learned more important practical and helpful informa­tion from members of the support group than from all the doctors we met, all the books I read, and all the internet searches I did. They helped me become a better care part­ner and learn how to deal with my own needs as my wife’s disease progressed.

  Importantly, it was just blind luck that led me to my essential support group because the neurologist caring for my wife never mentioned how support groups might be helpful for either of us. Shortly after I joined the spouse’s support group, I asked everyone how they had learned about our group; out of 15 of us, only 1 had learned about our support group from a neurologist.

  In another article I wrote that was published in 2011, I noted, “Some cities and some states have local and state associations that provide a multitude of support groups for both the patients, their spouses/caregivers and for non-spouse caregivers, often through branches of the Alzheimer’s Association, the Alzheimer’s Foundation, or hospitals. If there are such groups near where your patient and spouse live, please refer them to those groups or organizations. If not, please consider speaking with leaders of your state’s associations to have such groups formed. Also, become aware of the excellent online support groups available that you can recommend.”² Some resources for finding support groups are provided in the Box; you can use the QR code there to access a stand-alone version of this that you can print and share with your patients and their care partners.

Increase in Support Groups, But Not Neurology Referrals

Within 2 years, more support groups were forming on Long Island for people with various stages of AD and for their care partners, and more online groups were becom­ing available. Neurologists, however, were still not rou­tinely discussing the existence and importance of support groups with their patients with AD or those patients’ care partners. In a 2013 article published in the Journal of the American Geriatrics Society, I wrote, “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.”³

   The increasing number of AD support groups on Long Island and elsewhere, both for people with AD and their care partners, is a sign of progress. However, neurologists are still not routinely referring patients and care partners to such groups.

   For the past 2 years I have been a member of the Geriatric Emergency Care Applied Research Network 2.0 (GEAR 2.0) Task Force. GEAR is “a National Institutes of Health funded program working to advance the science supporting emer­gency care for people with dementia.”⁴

  During many zoom meetings and online exchanges, care partners and people in early stages of AD have told me that their neurologists have not discussed support groups with them.

  I have also had many interactions with AD care partners and people with early onset AD as a member of several AD research panels sponsored by the Center for Information and Study on Clinical Research Participation (CISCRP).⁵

 Through this work, I have again been told many times by people with AD and care partners that neurologists are not routinely discussing the importance of support groups, let alone where to find such groups.

BOX.   How To Find Alzheimer Disease and Other Dementia Support Groups

Call the Alzheimer Association 24/7 Helpline 1-800-272-3900 Provides information about in-person and virtual support groups in your area

Visit the Alzheimer Association Online Community alzconnected.org An online community with multiple message boards where patients and caregivers can ask questions and find answers and support from peers

Community Resource Finder communityresourcefinder.org from the American Association of Retired Persons and the Alzheimer Association Allows individuals to search for support groups and other resources by zip code

Lewy Body Dementia Association lbda.org/local-support-groups Offers interactive support group finder for both patients and care partners

The Association for Frontotemporal Degeneration Helpline 1-866-507-7222 Provides information about in-person and virtual support groups in your area

The Association for Frontotemporal Degeneration Support Group Finder theaftd.org/living-with-ftd/aftd-support-groups/ Offers interactive support group finder for both patients and care partners

                                                                                          (Continued on page 55) 

(Continued from page 46)

 Research Supports Referral to Support Groups

   Last summer, citing a 2015 study reported in the International Journal of Geriatric Psychiatry, medical writer Sherry Christiansen wrote: “Support group members often give each other tips on how to manage the various chal­lenges that arise. Not only can Alzheimer’s support groups provide information, but studies have shown that they can help reduce depression and improve the quality of life and self-esteem for people with AD who have mild cognitive impairment (early Alzheimer’s), as well as those in the later stages of the disease (ie, Alzheimer’s dementia).”^6,7

   According to the online “Caregiver’s Corner” section of the Fisher Center at Rockefeller University website, “Research shows that when family members and caregivers are educated about the disease and involved in the per­son’s care, the person who has Alzheimer’s benefits. When the family and caregiver of a person with Alzheimer’s understand the disease and learn how to communicate and interact with the person in ways appropriate to the disease stage, they are better able to reduce behavioral problems and improve the quality of life for all involved.”⁸

Conclusion

   Support groups for patients with AD and their care partners can improve their quality of life, but many neu­rologists are not referring to support groups. This leaves patients and care partners without an essential part of treatment. I urge all neurologists to find out about support groups in their area and inform their patients not only of these groups’ existence, but also of how such groups can be helpful to their treatment. To do otherwise is to pro­vide less than the best care.

 

1. Vann A. Alzheimer’s and baby boomers. Am J Alzheimers Dis Other Demen. 2010;25(6):477-478.

2. Vann AS. 10 things you should do when the diagnosis is Alzheimer’s. Am J Alzheimers Dis Other Demen. 2011;26(2):93-96.

3. Vann AS. Caregiver support groups. J Am Geriatr Soc. 2013;61(8):1413.

4. Geriatric Emergency Care applied Research website. https://gearnetwork.org/about-gear-2/. Accessed May 19, 2022.

5. Center for Information and Study on Clinical Research Participation website. http://www.ciscrp.org. Accessed May 19, 2022.

6. Christiansen S. Alzheimer’s disease support groups. Verywell Health. https://www.verywellhealth.com/best-alzheim­ers-disease-support-groups-4844290 Updated on August 31, 2021. Accessed May 19, 2022.

7. Leung P, Orrell M, Orgeta V. Social support group interventions in people with dementia and mild cognitive impair­ment: a systematic review of the literature. Int J Geriatr Psychiatry. 2015;30(1):1-9.

8. The Fisher Center for Alzheimer’s Research Foundation. Caregiver’s Corner. https://www.alzinfo.org/treatment-care/ caregivers-corner/. Published 2022. Accessed May 20, 2022.

 

 

Allan S. Vann, EdD

Care Partner & Patient Advocate

Commack, NY

allansvann.blogspot.com

 

Disclosures

ASV reports no disclosures

Published in Practical Neurology, June 1922, Vol. 21, No. 5, beginning on p. 45.   Access at: https://practicalneurology.com/articles/2022-june/alzheimer-disease-support-groups

 (Unable to reproduce the QR download code for box ... sorry!!)