Personal Blog #37 … An AD Spouse Caregiver’s Emotions, Part 1 … Acceptance … 9/30/24

 I had 35 columns published in The Huffington Post (since renamed, HuffPost) in 2015-2016.  I discussed some of the emotions I was experiencing in 8 of those first 9 columns  while watching my wife, Clare, slowly dying due to her battle with Alzheimer’s disease (AD).  As Clare’s symptoms worsened, I went from being her loving husband to a distant memory in her mind.  Even when she no longer recognized our children, grandchildren, or friends, Clare still, somehow, recognized my face.  I honestly don’t know what she recalled about me, but she always smiled and looked happy whenever she saw me.

Clare spent most of her last 2 and a half years in an assisted living facility, except for 1 week in a hospital and 1 month in a psychiatric facility, and she lived her final 6 weeks in a nursing home.  Clare no longer knew my name, or that we were husband and wife. Clare referred to me simply as a “nice man” or ”nice lady,” often asking me to please help her find her husband.  Yet during that time and up until the last day of her life, during each visit Clare would smile and be so happy as soon as she saw my face.

I was feeling both married and widowed at the same time, and growing more depressed.  I knew that I had to do a better job of dealing with my emotions and feelings.  I did an internet search for words that described my feelings and I wrote some columns about a few of those emotions and feelings for The Huffington Post. 

Recently, while speaking with an AD caregiver having difficulties dealing with various emotions and feelings, I mentioned that I had experienced similar feelings.  My friend found our discussion helpful, and I thought that other caregivers might also find some comfort by reading about my own personal experiences dealing with difficult emotions and feelings as an AD spouse caregiver.

This is the first in a series of 10 Personal Blog columns I plan to write and post only on this site in the last week of each month through June, 2025.  This column expands upon my second column published in The Huffington Post in 2015 … the emotion/feeling of acceptance.  Future columns will discuss emotions and feelings I have never written about before in any forum.  For The Huffington Post, I wrote those 8 columns about some of my emotions in alphabetical order, and I plan to do the same for this series.  Hopefully, this series will be helpful to other AD caregivers who visit this site.

Acceptance … a month before turning 63, and more than 2 years after I first noticed symptoms of AD, comprehensive testing at an Alzheimer’s Disease Research Center in New York City led to my wife’s diagnosis of early onset AD.

Accepting that your wife has a fatal disease, one with no effective means of treatment or cure, is not easy.  But her diagnosis did not surprise me.  I accepted it.  In fact, I had expected that diagnosis months earlier, even though doctors were telling us that Clare’s symptoms were due to stress, anxiety, or depression.  Research I had been doing for 2 years made me feel certain that she was already in the early stages of AD

But my acceptance didn’t make it any easier to know that our lives would be changed forever.  Acceptance did not mean absence of pain.  Acceptance of her AD diagnosis hurt.  A lot.  And it kept on hurting.  Sadly, I had no way of knowing just how much more pain was to come after my acceptance of that AD diagnosis.

Pain came in waves, and just continued coming.  I had accepted that there is no way to effectively treat AD, and I had accepted that there is no cure.  I knew that after an AD diagnosis some people may only live for a year or two, some may live for 18-20 years, but the average time a person lived after an AD diagnosis was only 8 years.

Given Clare’s highly developed verbal skills, her fluency in several languages, and her young age, the geriatric psychiatrist who discussed the AD diagnosis with us said that we could reasonably hope for Clare to have 15 or more good years. I didn’t believe him.  I personally didn’t know of anyone who had even 10 good years after diagnosis.

This diagnosis became our new reality, and I had no other choice but to accept it.  But acceptance of my new reality did not mean that I had to like my new reality.  It did mean, however, that I had to learn to live with my new reality.  I had to learn how to get on with my own life, knowing that Clare would no longer be by my side during what we both had once hoped to be a lengthy retirement.

I knew that I had to accept that Clare and I would soon no longer be a “we” … those “we” days would soon be gone.  I knew that.  I knew that Clare would now have a future apart from me and I would soon have a future apart from Clare.  But knowing all of this didn’t make it any easier for me to move on.  Why was acceptance of my new reality so difficult to … accept?

A decade prior to Clare’s diagnosis, and shortly after her diagnosis, we had discussed what we wanted should severe health issues require either of us to ever need either 24/7 home health aides or placement in a facility.  In 2013, more than 6 years after I first observed Clare exhibiting AD symptoms, I placed Clare in an assisted living facility.

I was now living alone in “our” house, a house we had shared for 40 years. I still wanted to hold onto our past and wanted Clare to be part of a wonderful future … together … with me.  But that was no longer possible.  I knew that.  I had accepted that.  Painfully.

I wasn’t in denial.  I really wasn’t.  But I was finding it so very hard to accept our new lives.  I didn’t want to “let go” of Clare.  I was finding it so hard to accept my new life as an “I” instead of as part of a “we.”  There were lots of tears, lots of lying in bed at all hours of the day, lots of inertia.  And lots of pain.

Clare only lived for 7 years after her diagnosis.  She died in her sleep just one month before what would have been her 69^th birthday … 2 months before what would have been our 49^th anniversary.  Our “we” days were now gone forever. 

Acceptance … just the first of many emotions and feelings I was now experiencing and struggling with on a daily basis.

Top 5 Tips Physicians Can Share with Caregivers of People with Alzheimer Disease

 

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Alzheimer Disease & Dementia > Caregiver Essentials

Top 5 Tips Physicians Can Share with Caregivers of People with Alzheimer Disease

Allan S. Vann, EdD

 

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When a physician sees a patient with a diagnosis of Alzheimer disease (AD), they may also interact with the patient’s caregiver. Caregivers are an essential part of a person with AD’s treatment journey, and it is therefore critical to equip them with optimal care tools and strategies, and to help caregivers develop care plans early after diagnosis. In this article, I have drawn upon my own 10 years of experience as a spouse caregiver for my late wife, who was diagnosed with early onset AD, to provide physicians with my top 5 topics to bring up with caregivers of people with AD.

1. Make sure patients know where they are in their dementia journey and suggest they make plans accordingly.

When a physician makes a diagnosis of AD, it is essential that a patient and their caregiver understand exactly what that means for their daily life. You should clarify that, while AD progresses differently for each patient, one can never be sure how long it will take for significant impacts on normal activities to occur. Physicians do not need to “unduly frighten” their patients and caregivers, but they should be honest about the uncertainty regarding the timeline of transitions.

The unpredictability of cognitive decline became apparent when my wife and I were making travel plans. At my first AD spouse support group meeting, I mentioned that my late wife and I loved to travel and had already placed a deposit on an international trip we had planned to take in 12 months. A wise woman whose husband was in the moderate stage of AD whispered to me on the way out, “Allan, don’t wait 12 months to take that trip. Your wife may not be able to travel a year from now.” That night, I asked my wife where she would like to go if we could only take one more trip. She told me and then fell asleep, and then I booked that trip. We traveled 3 months later to another destination and that turned out to be our last major trip. My wife’s cognitive skills declined so quickly that the following year we were unable to take the international trip we had planned.

2. Broach the topic of long-term planning and long-term care options with your patients as early as possible.

There are numerous questions that you can ask caregivers of patients with AD:

What will you do if you can no longer care for your loved one by yourself? Can you rely on close family members or friends for support? Does your loved one prefer to stay at home with companions or health aides, or does your loved one prefer to be in a residential facility? Which do you prefer?

If not previously discussed, it is best to have these conversations as early as possible, ideally before the caregiver’s loved one has experienced significant cognitive decline. Caregivers need sufficient time to assess their options, visit potential care facilities, and to consider employing the help of home health aide providers. It can be especially helpful to include the person with AD in long-term planning conversations. The earlier that caregivers consider these options, the more prepared they will be at the different stages of transition that their loved one experiences. This is particularly important for the wide range of policies to which each care provider adheres, such as whether a facility uses a waitlist for admission, whether meals are provided, or whether a home health aide provider is available 24/7. You can refer caregivers to helpful information available on their state’s Department of Health website.

As each of these long-term care options carry different price tags, another aspect of long-term planning is finances. If possible, recommend that your patients and their caregivers meet with an eldercare attorney and financial advisor.

When my late wife and I retired, we discussed the possibility of long-term health care and decided that we did not want such care to take place in our home. Nine years later, my wife was in the early stages of AD, and we started visiting various facilities. It gave me some comfort to know that when I did eventually place my wife in an assisted living facility, it was the one where she had felt most comfortable during our site visits.

3. Discuss driving safety with patients and their caregivers.

As patients with AD experience cognitive and functional decline, they may also lose the ability to drive safely. Unfortunately, it is not possible for a physician to predict when exactly this may occur. A report from the American Academy of Neurology (AAN) notes the importance of physicians talking with patients and caregivers about the risk of driving once there is a diagnosis of AD or dementia.¹ Friends and family members are often the first to notice any changes in behavior, including driving habits, so physicians should discuss this topic during every patient visit and document any changes.

At some point, caregivers may need to take the keys away from their loved one with AD. This is often an extremely difficult and emotionally straining decision, but it is a decision that must be made in most cases. My advice is to encourage caregivers to take their loved one’s car keys away early, before their cognitive ability declines to the point where they get into an accident and cause injury or property damage, or become lost while driving and forget how to return home and call for help. These are frightening scenarios, but very real possibilities.

4. Suggest that caregivers explore caregiver support groups.

Earlier, I mentioned how a fellow member of an AD spouse support group meeting helped me to realize the importance of scheduling an earlier trip with my late wife, rather than wait 12 months for the international trip we had previously planned. Like me, many caregivers can benefit from participating in this type of caregiver support group. These groups provide an environment where caregivers in similar situations can share helpful tips, recommendations, strategies, or stories about common experiences and challenges. Additionally, such groups can provide emotional support and tactics for time management, activities, and advanced care planning.

It is often beneficial for caregivers to identify a group that matches their specific experience. For example, the group I mentioned was for partners or spouses of people living with AD. Other groups might be catered to children caring for their parents or grandparents.

As with everything, it is helpful for physicians to encourage caregivers to join support groups early in their care journey, as soon as possible after their loved one is diagnosed with AD. Let caregivers know that participating in these groups requires a certain level of commitment, but that they can provide significant benefits including valuable social interaction that can help the overall physical and mental health of caregivers.

5. Consider recommending adult social day care and other resources.

Social day care programs can be a relatively low-cost, win-win option for loved ones in early-to-moderate stages of AD and their caregivers. These programs provide opportunities for those with AD to engage socially with others in similar circumstances and to participate in activities including art, singing, dancing, and games. Caring for a loved one 24/7 can be extremely stressful, so these social day care programs can provide several hours of respite for caregivers. Physicians can assist caregivers by making them aware that these types of programs exist. Consider becoming knowledgeable about day care options in your geographic area or referring caregivers to local AD organizations, municipal senior citizen services, adult homes for seniors, and assisted living facilities that provide social day care services.

Final Thoughts for Physicians

The caregivers of each of your patients have one thing in common: We are each paddling our boats as hard as we can trying to stay afloat to support our loved ones. We may be paddling different boats, in different waters, and at different speeds, but we are all dealing with a similar situation. We are all trying to keep our heads above water. Your patients and their caregivers are dealing with this situation for the first time, but as a physician, you are in a position to provide guidance and suggestions that can drastically improve the quality of life not only for your patients, but also for their caregivers. Any advice you can offer, however small, may make a big difference in the lives of your patients and their caregivers.

1.     Iverson DJ, Gronseth GS, Classen S, Dubinsky RM, Rizzo M. Practice parameter update: evaluation and management of driving risk in dementia. Neurology. 2010;74(16):1316-1324. doi: 10.1212/WNL.0b013e3181da3b0f

Published online only on July 23, 2024 on The Neurology Hub website. The Neurology Hub is a site “designed for health care professionals to learn, collaborate, and share content and ideas in the field of neurology” and is sponsored by the journal, Practical Neurology.

This article can be accessed at:  https://theneurologyhub.com/article/top-5-tips-physicians-can-share-with-caregivers-of-people-with-alzheimer-disease

Personal Blog #36 … FDA Approves Donanemab (Kisunla) for Early Stages of Alzheimer’s Disease … 7/28/24

 A few weeks ago, the Food and Drug Administration (FDA) approved a new medication to treat people diagnosed with mild cognitive impairment (MCI) or in early stages of Alzheimer’s disease (AD).  The medication, donanemab, clears amyloid protein plaques from the brain and will be sold by Eli Lilly under the brand name, Kisunla. ¹

Readers of my Personal Blog (PB) columns may recall my previous PB about donanemab.  In PB#31, posted on this site on 5/8/23, I noted that whereas the FDA wanted more data before approving of this new medication, I would not have wanted my late wife to have taken donanemab had it been available to her in early stages of AD. 

My primary reasons noted in PB#31 were that the data indicated just a modest, if even noticeable, slowing of AD symptoms for a few months at best for some patients taking this medication … but there was also a serious risk of negative side effects.  I wrote that, in my opinion, the risk of those negative side effects … about 25% of patients taking donanemab suffered brain bleeds … far outweighed any possible benefits.  After receiving more clinical trial results the FDA has now given donanemab its approval, but my opinions of this new medication have not changed.

On July 2, 2024, Pam Belluck, health and science reporter for The New York Times, wrote in her article, “New Drug Approved for Early Alzheimer’s,” that this new amyloid protein clearing drug (costing $32,000 for one year of therapy) is “the latest in a novel class of treatments that has been greeted with hope, disappointment, and skepticism.” ¹

Belluck’s article quotes Dr. Michael Greicius, a Stanford University School of Medicine neurologist, who said he would not prescribe this new drug for his patients.  Dr. Greicius stated that if this medication was effective, “the data should show that individual patients who had more amyloid removed from their brains experienced slower rates of cognitive decline.”  ¹   However, Greicius said that whereas the Lilly data demonstrated successful removal of amyloid plaque from the brain, “there is no correlation in any of their studies between the removal of amyloid plaques and the clinical responses of individual patients.”  ¹

Lilly data used an 18-point cognitive scale to compare results of the group receiving donanemab and a placebo.  Their data showed that patients receiving donanemab had a seven-tenths of a point difference compared to those receiving a placebo. ¹   As I have written in several PBs and published articles, there is a vast difference between statistically significant differences demonstrated by testing in clinical trials and real-world performance.  In my opinion, the possible “reward” of minor slowing of decline for a period of several months, when weighed against a 25% risk of brain swelling or bleeding, is just not a good enough “risk/reward” ratio.

According to the FDA, a “black box warning” will appear on this new medication that is to be taken intravenously over about 30 minutes once a month, and readers of this blog should take note:

“The prescribing information includes a boxed warning for amyloid-related imaging abnormalities (ARIA). ARIA most commonly presents as temporary swelling in areas of the brain that usually resolves over time and may be accompanied by small spots of bleeding in or on the surface of the brain.  ARIA usually does not have symptoms, although serious and life-threatening events rarely can occur.

Patients who are ApoE ε4 homozygotes have a higher incidence of ARIA, including symptomatic and serious ARIA, compared to heterozygotes and noncarriers. Testing for ApoE ε4 status should be performed prior to beginning treatment to inform the risk of developing ARIA.

There is risk of infusion-related reactions, with symptoms such as flu-like symptoms, nausea, vomiting and changes in blood pressure, and hypersensitivity reactions, including anaphylaxis (severe, life-threatening allergic reaction) and angioedema (swelling).

The most common side effects of Kisunla were ARIA and headache.”  ²

 

1   New drug Approved for Early Alzheimer’s.  The New York Times, July 2, 2024.  Access at:  https://www.nytimes.com/2024/07/02/health/alzheimers-treatment-kisunla-donanemab.html

2.  FDA approves treatment for adults with alzheimer’s disease … FDA, U.S. Food & Drug Administration.  Access at:  https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-treatment-adults-alzheimers-disease

A Former AD Care Partner’s Perspective on Leqembi

 

Social workers facilitating support groups for Alzheimer’s disease (AD) care partners or for people in early stages of AD should expect many questions in the coming months and years about some of the newer AD medications that are receiving, or about to receive, FDA approval. How should social workers respond to these questions that may be asked by AD patients and care partners? Aside from the obvious response that such questions should be directed to the patients’ doctors, here’s the view of one former AD care partner. On July 6, 2023, the FDA gave full approval for Japanese drugmaker Eisai and its American partner Biogen to market its latest medication, lecanemab (to be known as Leqembi) for those with mild AD. Announcing the approval, Teresa Buracchio, acting director of the Office of Neuroscience in the FDA's Center for Drug Evaluation and Research, says, “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. This confirmatory study verified that it is a safe and effective treatment for patients with Alzheimer’s disease.”1 That same day, The New York Times noted that the FDA acknowledged that Leqembi clinical trial results indicated that those taking the new medication showed a significant difference on an 18-point scale measuring cognitive functioning and memory, and that Leqembi “slowed memory and cognitive decline by about five months for those receiving the medication as opposed to those receiving the placebo.”2 However, as a doctor noted in that same article, “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.”2 In that same New York Times article, the author noted that Leqembi will carry a” black-box warning” about possible side effects such as brain swelling and bleeding, with a notation that “additional caution should be exercised” when considering whether to give blood thinners to Leqembi patients. Elsewhere in that same article it’s noted that “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’s unclear if Leqembi contributed to their deaths because the patients had complex medical issues.” According to an NBC news release online on Leqembi that same day, “About 12.6 % of patients who got Leqembi in the trial developed brain swelling, compared with 1.7% of those in the placebo group. About 17% of the Leqembi group experienced brain bleeds, compared with 9% in the placebo group.”3 I don’t think my late wife would have considered taking such a medication. Why? Three reasons: First, just the procedure for having to get dressed and get into the car to go to and from a doctor’s office for IV injections every two weeks for a year would have been a very stressful experience. And there would be additional doctor visits for various brain and blood scans while receiving the medication. In addition, my wife always felt pain with injections and bled readily, with her skin turning all pretty colors whenever receiving a needle for any reason, possibly due to all the heavy-duty heart medications she was taking each day as well as 325 mg of daily aspirin. A second reason would be 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 much too heavy a 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, and other effects of this medication would have made her situation even worse. 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 really would have made in my wife’s life or in mine. 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 would have easily lessened whatever quality of life we still had. 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-world effect of this new medication—the demands placed upon the AD patient’s care partner. Even in early stages, some AD patients may need assistance in dressing and with mobility and may angrily object to going out in bad weather or going out at a certain time of day. Helping people with AD can strain even the best of relationships. In addition, many care partners are still working when their loved ones are in early stages, and time demands of taking loved ones to two office visits each month for IV injections, along with additional visits for brain scans and other required testing to remain in this program, could be an additional burden. And, of course, there’s the financial burden this would be for many people with AD and their care partners. Even with expected 80% reimbursement by Medicare, out-of-pocket costs would still be high for both the medication and the additional office visits and scans. “Patients with traditional Medicare will pay 20% of the bill for Leqembi, according to the federal Centers for Medicare and Medicaid Services. That means these patients could see an annual bill of more than $5,000.”4 As a former 24/7 AD spouse caregiver, I am often skeptical of reports of “statistically significant” test results because I find that, too often, such results do not translate into meaningful observable differences in the real world. There is a big difference between “statistically significant” and “clinically different.” I often think of “statistically significant” AD test results in this way. Suppose one has 2,000 equally healthy and robust house plants, each producing 100 healthy leaves, with each plant expected to live for one full year before losing all of its healthy leaves. Then, suppose a clinical trial is conducted to determine if something added to the water might produce healthier plants. During the clinical trial to test whether or not a chemical added to “enrich” the water is better than just plain water for these plants, 1,000 plants receive only regular water and 1,000 plants receive only “enriched” water for an entire year. Then suppose that after one year, the plants receiving regular water have 99 dead leaves, while the plants receiving enriched water “only” have 98 dead leaves. If the authors of that hypothetical study then concluded that the difference in dead leaves is statistically significant by some sort of testing metric, results would still be totally meaningless to me. The plant with “only” 98 dead leaves would not look appreciably healthier to me than the plant with 99 dead leaves. Statistically significant differences? Maybe. Clinically significant differences? Not to me. The bottom line, to me, is one would have two dead plants. I am hoping for the day when a new AD medication will prove clinically effective in the real world, which to me would lead to many, many months or years before symptoms develop, worsen, or disappear with no serious potential side effects. I don’t see that happening with Leqembi. I won’t get too excited about Leqembi or other new medications with similar “statistically significant” results that also carry great risks of dangerous side effects. Not just yet. I have been disappointed too many times. I have seen too many dead plants. Social workers must always be careful not to involve themselves in discussions about advantages and/or disadvantages of any medications, referring all such questions to medical personnel. As someone who has facilitated support groups for AD care partners in the past, I was often asked medical questions by participants in my group. So social workers must accept that they may be asked by some care partners, if not by people with AD, questions such as “I know you cannot give me medical advice, but as someone I trust, what would you do if it were your mother/father/sister/brother/spouse? At least you will now have this former AD care partner’s perspective! — Allan S. Vann is a retired public school principal and former Alzheimer’s disease (AD) spouse care partner. To date he’s had more than 100 articles about AD published in peer reviewed medical journals, caregiver magazines, on AD organizational websites, and in major newspapers. Although his wife died of AD in 2016, he remains an active AD advocate for change, continues writing for publication, and continues to serve on advisory panels to help educate professionals working with AD patients and their care partners.   References 1. FDA converts novel Alzheimer’s disease treatment to traditional approval. U.S. Food & Drug Administration website. https://www.fda.gov/news-events/press-announcements/fda-converts-novel-alzheimers-disease-treatment-traditional-approval. Published July 6, 2023. 2. Belluck P. New federal decisions make Alzheimer’s drug Leqembi widely accessible. The New York Times. July 6, 2023. https://www.nytimes.com/2023/07/06/health/alzheimers-leqembi-medicare.html 3. Lovelace B Jr. FDA grants full approval to new Alzheimer's drug meant to slow disease. NBC News website. https://www.nbcnews.com/health/health-news/leqembi-alzheimers-drug-fda-approval-eisai-biogen-rcna92377. Updated July 6, 2023 4. Kimball S. Medicare will pay for Alzheimer’s drug Leqembi. What patients and doctors should know. CNBC website. https://www.cnbc.com/2023/07/08/leqembi-and-medicare-what-patients-and-doctors-should-know.html. Published July 8, 2023.     Published as a Web Exclusive for Social Work Today, online only,  on 5/8/24 at https://www.socialworktoday.com/archive/exc_050724.shtml

 

Personal Blog #35 … Biogen is Ending Sale of Aduhelm … 2/1/24

Yesterday, 1/31/24, Biogen announced that it will stop selling Aduhelm, its Alzheimer’s disease (AD) medication, by the end of this year.  When initial approval was given by the Food and Drug Administration (FDA) to market this medication in 2021, FDA required Biogen to conduct additional studies to prove the efficacy of this new drug.  Biogen announced yesterday that it is ending its study needed to obtain full approval from the FDA. 

Readers may remember reading my Personal Blog #23, posted on this site on 6/11/21 … “Letter to Acting FDA Commissioner re Aduhelm.”  In the first paragraph of that PB #23 column, I wrote: “On 6/7/21, the FDA approved the drug Aduhelm, Biogen’s aducanumab medication, an intravenous infusion to be administered monthly for people with Alzheimer’s disease.  Despite not one member of the FDA’s Advisory panel voting to approve this med, FDA approved its use anyway.  FDA determined that since Aduhelm helped clear some amyloid protein from the brain, it may be “expected to help slow dementia.”  However, Biogen’s own data do not support such a claim, and readers can read my Personal Blogs #11 and #12 to learn more about results of clinical trials with this drug.” 

I also wrote the following: “For many patients and caregivers, the high costs of AD medications present an economic hardship. Money spent on (ineffective) 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.”

“I witnessed AD spouse caregivers having to spend life savings on AD meds.  Some had to sell their homes when placing spouses in assisted living or to cover costs of home health care aides.  Now even more will have to do so because of money needlessly spent on this latest bottle of hope you have approved.  Based upon data I have seen ... a difference of 0.39 on an 18 point scale of cognitive and functional ability ... I can understand why not one member of your 11 member Advisory panel of experts that evaluated the data for FDA voted for approval.”

“I am SO sorry that FDA has approved yet another costly "bottle of hope" that will now financially ruin the lives of more AD spouse survivors with virtually zero benefit to their loved ones.  This is just not fair to people with AD, and not fair to their eventually surviving spouses.”

I also shared an email correspondence I had with Dr. Janet Woodcock, then acting FDA Commissioner.  In one email I had written, “My gripe is that there is no clear evidence that this med will actually slow cognitive decline in a meaningful way.  Unless and until Biogen can produce clear evidence that their medication does slow cognitive decline to a significant extent, it remains only an expensive bottle of hope.”

I also quoted one of several members of the FDA Advisory panel who resigned from the panel in protest, Dr. Aaron Kesselheim, a professor of medicine at Harvard Medical School.  Kesselheim said that FDA’s decision on Biogen “was probably the worst drug approval decision in recent U.S. history … based on the debatable premise that the drug’s effect on brain amyloid was likely to help patients with Alzheimer’s disease.”

In the last paragraph of PB#23, I noted my final comment to acting FDA Commissioner Woodcock re Aduhelm: “I want so much to see a new medication that will truly slow down the progression of the disease to allow a longer period of quality of life.  I want so much to see development of a new medication that will successfully treat if not cure AD.  (But) When an Advisory FDA panel has 11 experts and not even one of those experts votes to approve this medication, one has to wonder how something like this could happen.”

According to yesterday’s report by The Associated Press (AP), about 2,500 people worldwide are currently taking Aduhelm.  The AP report further stated, “Initially priced at $56,000 a year, analysts predicted it would quickly become a blockbuster that would generate billions for Biogen.  Medicare raised the premiums it charges for its coverage partially because of an expected influx of Aduhelm claims.  But doctors were hesitant to prescribe the IV drug, given weak evidence that it meaningfully improved Alzheimer’s patients lives.”

Although it comes as no surprise to me, I am deeply saddened to see yet another much hyped potential AD medication be declared a failure.  I have expressed my concerns about 2 other new AD meds targeting amyloid proteins (plaques) in the brain in Personal Blogs #28, #31 and #32.  These columns expressed my strong views on Lecanemab (now marketed as Leqembi), and Donanemab, a med that the FDA is expected to consider for approval within the next month or two. 

Given Biogen’s failure with Aduhelm, I can only reiterate what I wrote in last month’s PB #34.  Until science discovers exactly what causes AD … and as of today there is no definitive proof that AD is caused by the build-up of amyloid proteins in the brain … it will be extremely difficult if not impossible to develop a medication that can prevent AD or treat AD effectively.

 

 

 

 

Personal Blog #34 … Will 2024 Be the Year We Finally Discover the Cause(s) of Alzheimer’s Disease? … 1/14/24

I didn’t know much about Alzheimer’s back in 2007, but that was the year when I started searching the Internet for reasons to explain why, in my opinion, my wife was exhibiting worrisome behaviors.  Nobody else seemed to be noticing those behaviors, but I was seeing them more and more.  I continued worrying, I continued educating myself, and by early 2008 I was convinced that my wife was already dealing either with Mild Cognitive Impairment (MCI) or the early stages of Alzheimer’s disease (AD). 

Although my wife saw no reason to do so, I was able to convince her to see a neurologist after we returned from a particular trip in 2007.  During that trip, my wife exhibited many worrisome behaviors.  She was forgetting simple things (like our hotel room number or the names of our children and grandchildren), losing and misplacing things (leaving her sweater, coat, camera, and pocketbook in hotel rooms and restaurants) and was frequently disoriented when visiting sites in cities. 

My wife and I had recently entered our 60s and, like many friends our age, we were already starting to have those occasional “senior moments” when we’d forget something we knew well.  But my wife getting us lost on a regular basis was a major worrisome behavior.  I always got lost because I have no sense of direction, but I had always relied upon my wife’s “built-in GPS system” that, until that trip, had always guided us correctly wherever we were.  On that 2007 trip, however, even I knew she was repeatedly leading us in the wrong direction, we were frequently lost, and I, the one with no sense of direction, had to somehow lead us back to the correct location.

Throughout the rest of that year and in 2008, my wife’s doctors … first just our internist, and then the neurologist … saw no signs of MCI or AD.  They were both treating her first for stress, then for anxiety, and then for depression.  Throughout that time, I could not get my wife to agree to see another doctor for a second opinion, and each time I’d bring up that suggestion she would scream at me saying it was unnecessary.  Towards the end of 2008 and into early 2009, the neurologist suggested that my wife also be seen weekly by a clinical psychologist to help her with “coping mechanisms.”

At home I was regularly seeing new worrisome behaviors emerge, but none of my wife’s doctors observed these behaviors and all of her cognitive testing (MMSE tests, mostly) and brain scans seemed to be normal.  Despite what the doctors told me, I was now totally convinced that my wife was in the early stages of AD based upon all of my online reading from highly reputable governmental sites (such as NIA, NIH, and CDC), hospital sites (such as Mayo Clinic, Johns Hopkins, and Cleveland Clinic) and organizational sites (such as the Alzheimer’s Association, Fisher’s Center for Alzheimer’s Research Foundation, and UsAgainstAlzheimer’s).

In early 2009, feeling very frustrated that my wife was not properly diagnosed and was not being treated properly, I confronted the clinical psychologist.  I asked that if it were his wife being treated for more than a year for stress, anxiety, depression… and was actually getting worse … would he take his wife for a 2^nd opinion?  The psychologist said he had just spoken that morning with my wife’s neurologist.  I cut him off in mid-sentence, saying I had no faith in that neurologist.  I again repeated, would he take his wife for a 2^nd opinion?  The psychologist, now red-faced, said yes.  I turned to my wife and asked, “Now can I take you for a 2^nd opinion?”  She said “yes.”

Within a month my wife was seen by a geriatric psychiatrist affiliated with an Alzheimer’s Disease Research Center.  After just two lengthy visits and many hours of bloodwork, interviews, cognitive testing (not just the MMSE, but many tests), and new brain scans … and lengthy interviews of me to determine behaviors I was witnessing …  my wife was diagnosed with early onset AD.  Within a month my wife was taking Aricept, enrolled in a promising clinical trial, and my frustrations eased considerably because I now felt (in retrospect, naively so) that my wife was finally being treated effectively.

It has now been 15 years since my wife’s diagnosis in 2009.  What have we learned about the cause or causes of AD in those 15 years?  Sadly, the short answer is … not all that much.

Fifteen years ago I learned about amyloid-beta proteins (plaques) and tau proteins (tangles) and noted that most AD research money flowed into projects intended to definitively determine how one of both of those proteins were the cause(s) of AD.  Unfortunately, here we are in 2024 and we still haven’t conclusively determined if that is true, and at this stage many researchers are wondering if the presence of amyloid proteins may the results of AD rather than the cause.

Based upon a 2022 study at the University of Cincinnati, the chief neurologist and his research colleagues “hypothesized that plaques are simply a consequence of the levels of soluble amyloid-beta in the brain decreasing. The paradox is that so many of us accrue plaques in our brains as we age, and yet so few of us with plaques go on to develop dementia.” ¹

The latest statement from CDC, the Centers for Disease Control and Prevention, states the following: “Scientists do not yet fully understand what causes Alzheimer’s disease. There likely is not a single cause but rather several factors that can affect each person differently.” ² 

CDC does note some risk factors for AD  and several of those are listed on the CDC site.  Unfortunately, people have no control over the number one risk factor … age.  As we have long known, “Age is the best known risk factor for Alzheimer’s disease.”   All other risk factors noted by CDC are either ones we cannot control (e.g., family history) or statements with caveats such as, “a healthy life style may (my emphasis added) play a role in developing AD.” 2

The NIA, National Institute of Aging, notes the following on its site: “In recent years, scientists have made tremendous progress in better understanding Alzheimer’s and the momentum continues to grow. Still, scientists don’t yet fully understand what causes Alzheimer’s disease in most people.” ³  The NIA site suggests something similar to what is on the CDC site.  In its section, “What causes AD,” The NIA page has the following statement: “The causes probably (my emphasis added) include a combination of age-related changes in the brain, along with genetic, environmental, and lifestyle factors. ³

Similar non-emphatic statements can be found on just about any reputable site.  According to the Mayo Clinic, “The exact causes of Alzheimer's disease aren't fully understood … Scientists believe (my emphasis added) that for most people, Alzheimer's disease is caused by a combination of genetic, lifestyle and environmental factors that affect the brain over time.” ⁴

Organization websites, such at that of the Alzheimer’s Association, say something similar: “Researchers believe there isn't a single cause of Alzheimer's disease. It likely (my emphasis added) develops from multiple factors, such as genetics, lifestyle and environment. Scientists have identified factors that increase the risk of Alzheimer’s. While some risk factors — age, family history and heredity — can't be changed, emerging evidence suggests there may (my emphasis added) be other factors we can influence.” ⁵

So, whereas we have made some progress in learning about AD in these past 15 years, we still haven’t learned what causes AD.  It is extremely difficult to effectively prevent or treat a disease when we do not know the cause(s).  We are basically proceeding with common-sense advice that seems rational … that a healthy life style of eating nutritious foods, regularly exercising, avoiding brain injuries, etc. may (my emphasis added) prevent some (my emphasis added) people from developing AD.  But, as of today, we do not know that for sure.

It is too late for my wife, who died in 2016, and millions of others who have passed away directly because of AD or with AD as a major contributing factor.  Although continually listed among the top 10 causes of death in this country, the number of people dying with or because of AD is considered significantly greater than what is reported on death certificates.  According to the Alzheimer’s Association, “Death certificates for individuals with Alzheimer’s often list acute conditions such as pneumonia as the primary cause of death rather than Alzheimer’s … even though Alzheimer’s disease may well have caused the acute condition listed on the death certificate.” ⁶

When I received the death certificate from the nursing home after my wife’s death, I was shocked to note that AD was not mentioned as either the direct cause or as a contributing cause. ⁷   When I asked the nursing home doctor why, his response was that he couldn’t prove that AD was the cause.  When I asked why he didn’t even include AD as a contributing cause, he said he couldn’t prove that either. 

Therefore, 2016 CDC mortality statistics for deaths due to AD in the U.S. did not include my wife’s death.  On page 6 of its 2016 report on mortality rates, CDC listed AD as the 6^th leading cause of death in this country in 2016. ⁸   On page 62 of that same CDC report, the following statement appears: “Quality of mortality data is largely dependent on proper and thorough completion of death certificates by certifiers. Accuracy and completeness of information entered on death certificates can vary by state from year to year.” ⁸   One can only wonder how many thousands of deaths in this country due in whole or part to AD each year have not been reported accurately on death certificates.

I hope our government continues to increase funding for AD research in hopes of finding an effective means of prevention or cure.  In 2009, the NIH allocated $457 million for AD research. 9   I am very pleased to note that estimated NIH funding for AD research proposed for 2024 is approximately $3.5 billion. 10   Hopefully, increased federal spending will result in promising research and discovery.

Discovering a definitive way to prevent AD is the goal, but I’d be very happy if we can just learn how to more effectively treat this disease.  Recent medications approved by the FDA to help those with AD do not excite me.  In fact, if my wife were still alive, I doubt whether she or I would have wanted her to take any of these new medications. ¹¹   

But even if AD remains a death sentence with no cure, treatment that can enable people with AD to maintain and enjoy a high quality for life for 10, 15, or 20 years after diagnosis would be a wonderful advance. 

Maybe 2024 will be the year when this happens.

1.  Tedeschi, Tim. UC study: Decreased proteins, not amyloid plaques, tied to Alzheimer’s disease.  Accessed on January 14, 2024.  https://www.uc.edu/news/articles/2022/09/decreased-proteins-not-amyloid-plaques-tied-to-alzheimers.html

2.  Alzheimer’s Disease and Healthy Aging.  Centers for Disease Control and Prevention.  Accessed on January 14, 2024.  https://www.cdc.gov/aging/alzheimers-diseasedementia/aboutalzheimers.html#:~:text=Scientists%20do%20not%20yet%20fully,risk%20factor%20for%20Alzheimer's%20disease.

3.  What causes Alzheimer’s disease?  Accessed on January 14, 2024.    https://www.nia.nih.gov/health/alzheimers-and-dementia/alzheimers-disease-fact-sheet 

4.  Alzheimer’s disease.  Mayo Clinic.  Accessed on January 14, 2024.  https://www.mayoclinic.org/diseases-conditions/alzheimers-disease/symptoms-causes/syc-20350447

5.  Causes and Risks for Alzheimer’s disease.  Alzheimer’s Association.  Accessed on January 14, 2024.  https://www.alz.org/alzheimers-dementia/what-is-alzheimers/causes-and-risk-factors

6. 2023 Alzheimer’s Disease Facts and Figures.  Alzheimer’s Association.  Accessed on January 14, 2024, p. 35.  https://www.alz.org/media/documents/alzheimers-facts-and-figures.pdf

7.  Vann, Allan S.  Reporting Deaths of Patients with Alzheimer’s.  Journal of the American Geriatrics Society.  December, 2016. 64:12, pp. 2419-2420.

8. Deaths: final data for 2016, July 26, 2018.  Centers for Disease Control and Prevention.  Accessed on January 14, 2024.  https://stacks.cdc.gov/view/cdc/57989

9.  Research Priority Setting, and Funding Allocations across Selected Diseases and Conditions.  National Institutes of Health.  Accessed on January 14, 2024.   https://www.gao.gov/assets/gao-14-246.pdf

10.  Estimates of Funding for Various Research, Condition, and Disease Categories (RCDC).  NIH RePORT.  Accessed on January 14, 2024.  https://report.nih.gov/funding/categorical-spending#/

11.  Vann, AS. ”Reflections of An Alzheimer’s Spouse.”  Personal Blog columns # 28, 31, and 32 discuss recent medications approved by the FDA within the past 2 years.  https://allansvann.blogspot.com/

Personal Blog # 33 … Concerns About AD? Be Sure to See the Right Doctor! ... 10/10/23

 

Personal Blog # 33 … Concerns About AD?  Be Sure to See the Right Doctor!

A friend of mine recently told me about the problems she went through trying to obtain an accurate diagnosis for the causes of increasingly worsening gastrointestinal issues her daughter was facing.  Despite being seen and treated by her primary care doctor, an internist, a gastroenterologist, and numerous MDs in hospital ERs, her issues continued to worsen.  Why?  It turned out that for many years she was repeatedly misdiagnosed and given medications that were not helpful.  Conditions such as anemia, appendicitis, nervous stomach, stress, hemorrhoids, and ulcerative colitis are just some of the misdiagnoses given to people who actually have Crohn’s.

At a certain point, my friend’s daughter was seen by a gastroenterologist with experience diagnosing and treating patients with Crohn’s disease.  Once properly diagnosed and treated for Crohn’s disease, there was immediate improvement in her condition and ability to function more normally.

According to the Mayo Clinic website, “Crohn's disease is a type of inflammatory bowel disease (IBD). It causes swelling of the tissues (inflammation) in your digestive tract, which can lead to abdominal pain, severe diarrhea, fatigue, weight loss and malnutrition.  Inflammation caused by Crohn's disease can involve different areas of the digestive tract in different people, most commonly the small intestine. This inflammation often spreads into the deeper layers of the bowel.  Crohn's disease can be both painful and debilitating, and sometimes may lead to life-threatening complications. There's no known cure for Crohn's disease, but therapies can greatly reduce its signs and symptoms and even bring about long-term remission and healing of inflammation. With treatment, many people with Crohn's disease are able to function well.  (https://www.mayoclinic.org/diseases-conditions/crohns-disease/symptoms-causes/syc-20353304)

Doctors misdiagnosing various diseases is nothing new, and my friend’s daughter was fortunate to finally be with a doctor who correctly diagnosed and treated her condition.  However, there are steps one can take to help minimize chances of misdiagnoses.  By reading about some of the mistakes I made with my wife, some readers may be able to avoid similar mistakes with their loved ones when there are concerns about AD.

Readers of my articles and blog columns already know that my wife, who died in 2016 due to AD, had been misdiagnosed for several years.  When I first began to notice behavioral changes in my wife and grew increasingly concerned that those changes might be signs of AD, we discussed these changes with our primary care doctor.  That doctor administered an MMSE … Mini-Mental State Evaluation … a very common test used by doctors to screen for possible AD.  My wife aced the test with a perfect score.  Unfortunately, I didn’t know that the MMSE was never intended to be used to screen for possible AD because, among other reasons, it does not test higher order thinking skills.  Our doctor gave my wife a prescription to reduce stress and anxiety.

My mistake was thinking that all was well based upon that MMSE score.  Even though our family physician said he was not an expert in AD, he could not detect any problems that, in his opinion, would warrant any additional testing. 

Months later, and observing new and worsening behaviors that I now thought could possibly be signs of AD, we met with the most highly respected neurologist in my geographic area, chair of the neurology department at a large and well-respected hospital.  I was also quickly educating myself about AD by visiting various internet sites such as those of the NIH, Mayo Clinic, Johns Hopkins, and the Alzheimer’s Association.

I was maintaining weekly logs noting new or worsening behaviors that I felt were clear signs of Mild Cognitive Impairment (MCI), if not early signs of Alzheimer’s disease (AD).  During the next 12-18 months, at every visit with every doctor I shared my latest logs, but doctors dismissed my logs without comment … often not even bothering to take time to skim or read what I had written.  The neurologist treating my wife for stress, for anxiety, and depression then also had her meet weekly with a clinical psychologist. 

My mistake was thinking that any neurologist or clinical psychologist would be easily able to diagnose AD.  My wife’s neurologist, a specialist in other brain disorders, was not an expert in AD.  My wife’s psychologist was a specialist in treating anxiety disorders, not AD.  Signs of AD that were obvious to me were misinterpreted by them and her diagnosis remained stress, then anxiety, and then depression … not AD.  I shared what the neurologist and clinical psychologist were saying about my wife with our primary care doctor, telling him that what I was observing seemed to clearly indicate early stages of AD.  Our doctor said that, based upon the behaviors I was observing, it was possible that my wife was in early stages of AD … but he deferred to the opinion of the neurologist who had much more experience with brain issues.

My mistake was not being strong enough to challenge my wife who continued to resist going for a second opinion.  We “fought” over it, but invariably she’d adamantly argue that she didn’t need to see another doctor and I couldn’t force her to do so.  I backed down each time, but I should never have backed down.  My wife said that since our family doctor, the neurologist, and the clinical psychologist all agreed that her problems were due to stress, anxiety, and/or depression … not MCI  and certainly not AD … there was no need to get another opinion. 

I was only able to bring my wife for a second opinion after I decided to confront the psychologist in my wife’s presence after a particular session.  I asked if his wife was being treated for stress, anxiety, and/or depression … and if his wife not only was not improving but was actually getting worse … would he take his wife for a second opinion?  When he said, red-faced, that yes, he would do so, I turned to my wife and asked, “Now will you let me take you for a second opinion?”

I was not going to repeat my mistakes of the past.  I had already gathered information on three doctors whose entire practices were focused on diagnosing and treating people with AD.  Two were geriatric psychiatrists affiliated with an Alzheimer’s Disease Research Center (ADRC) and one was a neurologist at another major hospital.  I showed the information on all three doctors to my wife and she chose one of the two geriatric psychiatrists.  We made an appointment and when the doctor learned that I had been keeping weekly logs of her behaviors, he asked me to email copies of those logs prior to our visit.  We then had several email exchanges about those behaviors, and even before our first visit I felt that we were now finally seeing the right doctor! 

My wife’s initial 3+ hour evaluation included the MMSE but also many, many more tests. After just thirty minutes spent evaluating my wife, the geriatric psychiatrist said that my wife was definitely not suffering from stress, anxiety or depression.  He wanted her taken off all of those medications, saying that ”something is going on in her brain’s frontal lobe.”  One month after all of her testing was completed … extensive cognitive testing, blood work, brain scans, physical exams, etc. … I received a call from the ADRC that, after a team meeting discussing all of her test results, my wife was diagnosed with probable early onset AD.

What is my advice to people with concerns about possible signs of AD in their loved ones?  Don’t visit just any doctor.  See  only a doctor experienced in diagnosing and treating people with AD.  Not all brain doctors … not even specialists such as neurologists and geriatric psychiatrists … have enough experience with AD to diagnose it properly.  Make sure you see a doctor who can do this.

And one more thing, something that is very sad to note.  Not all ADRCs will even take the time to make an initial diagnosis for people with concerns about possible AD symptoms!  I only recently learned about a friend who felt that he may be experiencing early signs of AD.  He made an appointment to see a specialist at his local ADRC, but they refused to see him once they learned that he did not yet have “sufficient” testing by other doctors first … brain scans, blood work, etc.

I emailed the following question to the person in charge of ADRCs at the National Institutes of Health: “Can my friend simply go to an ADRC for a complete evaluation, or must he first undergo imaging and blood work and other tests by his internist or neurologist.  So far he is acing the MMSE given to him by his internist but yet he recognizes he is still having cognitive problems.  Can he just get a consult at his local ADRC?  Following is the response I received:

“Thank you for contacting the federal government’s National Institute on Aging (NIA), part of the National Institutes of Health (NIH) at the U.S. Department of Health and Human Services. NIA was established to improve the health and well-being of older adults through research. The institute conducts and supports basic, clinical, and social and behavioral research on aging and the special problems and needs of older adults and is the lead federal agency for Alzheimer’s disease and related dementias research.   We appreciate your interest in the services provided by the Alzheimer’s Disease Research Centers.  While NIA provides funding to these Centers, we are not involved in their daily operations. Therefore, you will need to contact each Center you are interested in to inquire about their protocols for diagnosis and testing.”

That response is very unfortunate.  An ADRC has precisely those experts who should be available to meet with people who have the earliest AD concerns.  Months of delay before seeing such experts will undoubtedly lead to increased mental anguish.  In addition, the need to undergo additional expensive testing is a critical issue if one does not have outstanding health insurance.  Conducting initial AD diagnoses are too important … they should be included in all ADRC mission statements and protocols for diagnosis and testing.

One more thing.  If you do go to a doctor who administers the MMSE and makes a decision solely based upon those test results, please go to another doctor … asap!  There are many evaluative instruments better than the MMSE to help in diagnosing MCI or AD.  No doctor should still be using the MMSE, a test created in 1975, as a sole test to diagnose probable AD.  A score of 24 or less on the MMSE is considered indicative of possible cognitive impairment.  As I noted, my wife continually got a score of 30 in her earliest years of undiagnosed AD.  But even two years after being diagnosed with AD at the ADRC, my wife was still scoring 25 or higher on the MMSE!  Enough said.