Estate Planning Blog Articles

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What’s the Criticism of the New Alzheimer’s Drug?

Three members of the FDA panel overseeing research have resigned since the approval this week, including Dr. Aaron Kesselheim, a professor of medicine at Harvard Medical School, who said in a letter the agency’s decision on Biogen “was probably the worst drug approval decision in recent U.S. history.”

CNBC’s article entitled “Biogen Alzheimer’s drug and the battle over dementia treatment of the future” reports that last November, in an 8-1 vote, that panel said Biogen’s late-stage study didn’t provide “strong evidence” showing that aducanumab effectively treated Alzheimer’s; two other panelists said that the data was “uncertain.”

While some experts see Aduhelm an “effective treatment” for a disease that affects millions of Americans, others have concerns about the FDA ruling’s implications for the panoply of other potential treatment options that are in late-stage development.

An immediate challenge facing other researchers working on a wider Alzheimer’s drug pipeline will be to keep participants in ongoing trials. In most cases, many Alzheimer’s sufferers will quit other drug studies to pursue treatment with the newly approved Aduhelm. This will make the trial data for those alternative drugs less useful, even though the drugs in question might one day prove safer, more effective, or more appropriate for different stages of the disease’s progression. Nonetheless, Aduhelm’s approval is seen by many as a big boost towards those efforts.

Some major drug companies stopped efforts to research brain diseases, including Pfizer and Boehringer Ingelheim in 2018. Biogen had given up on Aduhelm at one time in the clinical trials in 2019 before reversing its decision. This was after decades of failure in search of a breakthrough.

The National Institutes of Health spent two to three times more on heart disease and cancer research than on dementia in recent years, while a lack of qualified participants for clinical trials also slowed progress.

Aduhelm’s clinical trial data demonstrated that the drug successfully targets and clears out clusters of a specific type of protein that are thought to be responsible for Alzheimer’s. However, it gave insufficient evidence to prove the drug provides patients with cognitive benefits. Known among scientists as aducanumab, it works by offering an array of identical antibodies that are cloned from white blood cells. These antibodies are chosen for their targeting abilities, since they can identify specific proteins, called beta amyloids, that have constructed particular formations in the body. There’s extensive evidence suggesting that these beta amyloid formations, also known as “pathological aggregates” or “plaques,” are a major driver of Alzheimer’s disease, though the exact causal mechanisms are still not fully understood.

“What we’re going to find out from the use of this drug one way or the other, is whether or not the amyloid clearing hypothesis is correct,” says USC health economist Darius Lakdawalla, who argues the continued trialing of Biogen’s drug will prove useful to that confirmatory effort.

“If it is correct, then I think it opens the door for a lot of innovation, a lot of drug candidates that are going to try to clear amyloid in the future pursuit of that hypothesis.”

Reference: CNBC (June 12, 2021) “Biogen Alzheimer’s drug and the battle over dementia treatment of the future”

Will Mediterranean Diet Stave Off Alzheimer’s?

Researchers at the German Centre for Neurodegenerative Diseases in Bonn found the Mediterranean diet could protect the brain from disease triggers linked to Alzheimer’s, specifically protein deposits and the rapid loss of brain matter.

Barchester’s recent article entitled “Mediterranean diet could lower risk of dementia, study suggests” reports that Alzheimer’s disease is the most common form of dementia, affecting between 50 and 75% of people who are diagnosed with the condition.

Worldwide, approximately 50 million people have dementia. There are roughly 10 million new cases every year.

Alzheimer’s disease is the most common form of dementia and may contribute to 60–70% of cases.

Dementia is one of the primary causes of disability and dependency among older people worldwide.

There are physical, psychological, social, and economic impacts on people with dementia, as well as on their careers, families and society at large.

The recent German study results were published in the journal Neurology. The research involved 512 subjects, with an average age of 70 years. The participants were asked to fill out a questionnaire about the foods they regularly ate. Those who ate a considerable quantities of fish, vegetables and fruit, and only occasionally consumed foods considered less healthy, such as red meat–were given high scores on a scale used by the researchers.

Participants then underwent MRI brain scans and participated in tests examining cognitive functions, such as memory. The study also looked for levels of amyloid beta proteins and tau proteins in the cerebrospinal fluid. These are well-known signs of Alzheimer’s.

The results showed that those with the unhealthiest eating habits had more pathological levels of these biomarkers, when compared with those who regularly ate a Mediterranean diet.

In addition, individuals who regularly ate a significant quantities of fish, fruit and vegetables performed better in memory tests.

The lead author of the study, Tommaso Ballarini, expanding on the findings and explained: “There was also a significant positive correlation between a closer adherence to a Mediterranean-like diet and a higher volume of the hippocampus. The hippocampus is an area of the brain that is considered the control centre of memory. It shrinks early and severely in Alzheimer’s disease.”

The researchers are looking to re-examine the same study participants in four to five years, to have further insights into how nutrition can impact brain aging and health over time.

Reference: Barchester (May 10, 2021) “Mediterranean diet could lower risk of dementia, study suggests”

Link Possible between Diabetes, Dementia and Age

New research says those people who had type 2 diabetes for more than 10 years had more than twice the risk for developing dementia, as compared with those who were diabetes-free at age 70, according to Archana Singh-Manoux, PhD, of the Université de Paris in France.

MedPage Today’s recent article entitled “Diabetes, Dementia, and Age: What’s the Link?” reports that at age 70, every additional five years younger that a person was diagnosed with diabetes was linked to a 24% increased risk of incident dementia, even after adjustment for sociodemographic, health-related and clinical factors including cardiovascular disease, hypertension, body mass index and use of antidepressant or cardiovascular medications, among others.

This is equal to a dementia rate of 8.9 per 1,000 person-years among patients age 70 without diabetes versus a rate of 10 to 18.3 for those with diabetes, depending on age at onset:

  • Diabetes onset 5 years earlier: 10.0 per 1,000 person-years
  • Diabetes onset 6-10 years earlier: 13.0 per 1,000 person-years
  • Diabetes onset 10+ years earlier: 18.3 per 1,000 person-years

The strongest connection with incident dementia appeared to be younger age at onset of type 2 diabetes. Patients at age 55 who were diagnosed with diabetes within the past five years saw a twofold increased risk for incident dementia; those age 60 who were diagnosed with diabetes six to 10 years prior saw a similar twofold increased risk. However, late-onset diabetes wasn’t found to be tied to incident dementia. Prediabetes (fasting blood glucose of 110-125 mg/dL) also was not linked to risk of subsequent dementia. Singh-Manoux said this finding suggested that “a certain threshold of high glucose” might be needed to ultimately see hyperglycemia-induced brain injury.

However, cardiovascular comorbidities played into this link. Patients with diabetes who also had a stroke had a dramatically higher risk for dementia. Those with three heart conditions — stroke, coronary heart disease and heart failure – were at five times increased risk for subsequent dementia. Thus, these findings emphasize the importance of age at diabetes onset and cardiovascular comorbidities, when determining risk for dementia, the study authors said.

A few possible explanations could explain the connection between diabetes and dementia. “One hypothesis is that brain metabolic dysfunction is the primary driver of Alzheimer disease, highlighting the role of decreased transport of insulin through the blood-brain barrier, impairments in insulin signaling and consequently decreased cerebral glucose utilization,” they wrote. This idea was supported by findings from the 2019 SNIFF trial, which found some benefit with 40 IU of daily intranasal insulin for Alzheimer’s disease patients. The group also suggested that episodes of hypoglycemia, more often experienced by those with a longer diabetes duration, may increase the risk for dementia.

Reference: MedPage Today (April 27, 2021) “Diabetes, Dementia, and Age: What’s the Link?”

Does Sleeping Too Little Increase Risk of Dementia?

Researchers have looked at the issue of a lack of sleep and a link to developing dementia for many years, as well as other questions about how sleep relates to cognitive decline. The answers have been tough to find because it is hard to know if insufficient sleep is a symptom of the brain changes that underlie dementia — or if it can actually help cause those changes.

The New York Times’ recent article entitled “Sleeping Too Little in Middle Age May Increase Dementia Risk, Study Finds” reports that a large new study found some of the most persuasive findings to date that suggest that people who don’t get enough sleep in their 50s and 60s may be more apt to develop dementia when they are older.

The research, published recently in the journal Nature Communications, has limitations but also several strengths. Researchers monitored 8,000 people in Britain for about 25 years, starting when they were 50. They found that those who consistently reported sleeping six hours or less on an average weeknight were about 30% more likely than those who regularly got seven hours sleep (defined as “normal” sleep in the study) to be diagnosed with dementia nearly three decades later.

Drawing on medical records and other data from a prominent study of British civil servants called “Whitehall II,” which began in the mid-1980s, the researchers logged the number of hours that 7,959 participants said they slept in reports filed six times between 1985 and 2016. By the end of the study, 521 people had been diagnosed with dementia at an average age of 77.

The team was able to adjust for several behaviors and characteristics that might influence people’s sleep patterns or dementia risk, like smoking, alcohol consumption, how physically active people were, body mass index, fruit and vegetable consumption, education level, marital status and conditions like hypertension, diabetes and cardiovascular disease.

To further clarify the sleep-dementia relationship, researchers culled out those who had mental illnesses before age 65. Depression is considered a risk factor for dementia and mental health disorders are strongly connected to sleep disturbances. The study’s analysis of participants without mental illnesses found a similar association between short-sleepers and increased risk of dementia.

The link also held whether people were taking sleep medication and whether they had a mutation called ApoE4 that makes people more apt to develop Alzheimer’s.

Experts seem to agree that researching the sleep-and-dementia connection is challenging and that previous studies have sometimes produced confusing findings. In some studies, those who sleep too long (usually measured as nine hours or more) seem to have greater dementia risk, but several of those studies were smaller or had older participants. In the new study, results intimated increased risk for long sleepers (defined as eight hours or more because there weren’t enough nine-hour sleepers), but the association was not statistically significant.

The new study also looked at whether people’s sleep changed over time. There appeared to be slightly increased dementia risk in people who shifted from short to normal sleep—a pattern thought to reflect that they slept too little at age 50 and needed more sleep later because of developing dementia.

Reference: New York Times (April 20, 2021) “Sleeping Too Little in Middle Age May Increase Dementia Risk, Study Finds”

Can a Person with Alzheimer’s Sign Legal Documents?

If a loved one has been diagnosed with Alzheimer’s disease or any other form of dementia, it is necessary to address legal and financial issues as soon as possible. The person’s ability to sign documents and take other actions to protect themselves and their assets will be limited as the disease progresses, so there’s no time to wait. This recent article “Financial steps to take when dealing with Alzheimer’s” from Statesville Record & Landmark explains the steps to take.

Watch for Unusual Financial Activity

Someone who has been sensible about money for most of his life may start to behave differently with his finances. This is often an early sign of cognitive decline. If bills are piling up, or unusual purchases are being made, you may need to prepare to take over his finances. It should be noted that unusual financial activity can also be a sign of elder financial abuse.

Designate a Power of Attorney

The best time to designate a person to take care of finances is before she shows signs of dementia. It’s not an easy conversation, but it is very important. Someone needs to be identified who can be trusted to manage day-to-day money matters, who can sign checks, pay bills and supervise finances. If possible, it may be easier if the POA gradually eases into the role, only taking full control when the person with dementia can no longer manage on her own.

An individual needs to be legally competent to complete or update legal documents including wills, trusts, an advanced health care directive and other estate planning documents. Once such individual is not legally competent, the court must be petitioned to name a family member as a guardian, or a guardian will be appointed by the court. It is far easier for the family and the individual to have this handled by an estate planning attorney in advance of incompetency.

An often-overlooked detail in cases of Alzheimer’s is the beneficiary designations on retirement, financial and life insurance policies. Check with an estate planning attorney for help, if there is any question that changes may be challenged by the financial institution or by heirs.

Cost of Care and How It Will Be Paid

At a certain point, people with dementia cannot live on their own. Even those who love them cannot care for them safely. Determining how care will be provided, which nursing facility has the correct resources for a person with cognitive illness and how to pay for this care, must be addressed. An elder law estate planning attorney can help the family navigate through the process, including helping to protect family assets through the use of trusts and other planning strategies.

If the family has a strong history of Alzheimer’s disease or other cognitive diseases, it makes sense to do this sort of preparation far in advance. The sooner it can be addressed, even long before dementia symptoms appear, the better the outcome will be.

Reference: Statesville Record & Landmark (April 11, 2021) “Financial steps to take when dealing with Alzheimer’s”

Does Bacon Cause Dementia?

A recent study suggests there is a connection between eating 25 grams of processed meat per day and a 44% higher risk of dementia. That’s about a single rasher or strip of bacon.

Medical News Today’s recent article entitled “Dementia: 25 grams of processed meat per day may raise relative risk” reports that this research also found a link between eating unprocessed red meats, like beef, pork, and veal, and reduced risks of all-cause dementia.

A gene variant known as the APOE ε4 allele, which increases a person’s risk of dementia by 3–6 times, didn’t appear to affect the relationship between diet and the condition. Those with dementia have difficulties with their memory, attention, thinking and reasoning that interfere with everyday life. These cognitive difficulties aren’t part of the typical aging process.

According to the Centers for Disease Control and Prevention (CDC), in 2014, about five million adults in the U.S. had dementia, but the CDC estimates this number may be close to 14 million by 2060. And the World Health Organization (WHO) reported that there are around 50 million dementia cases globally, with around 10 million new cases being diagnosed annually.

This new study from scientists at the University of Leeds in the U.K. suggests there is a relationship between eating processed meat in particular and an increased risk of developing dementia. This includes sausage, bacon, salami and corned beef.

However, the research also showed that red meat may have a protective effect against dementia.

The scientists analyzed data from the UK Biobank, a database of genetic and health information from around half a million volunteers in the U.K. aged 40–69 years. The participants completed a dietary questionnaire and completed 24-hour dietary assessments. This let the researchers estimate the total amount of meat each participant regularly consumed and how much of each type they ate.

The database also let them identify which participants had the gene variant APOE ε4 allele, which is known to increase a person’s risk of dementia. The researchers then used hospital and mortality records to identify subsequent cases of dementia from all causes, Alzheimer’s disease and vascular dementia during the follow-up period of approximately eight years.

Of the 493,888 participants, 2,896 had all-cause dementia. These included 1,006 cases of Alzheimer’s disease and 490 cases of vascular dementia.

To estimate the role of meat consumption, the researchers had to account for a wide range of other factors that are known to affect a person’s likelihood of having dementia, such as age, gender, ethnicity, education and socioeconomic status. They also considered lifestyle factors, such as smoking, physical activity and consumption of fruits and vegetables, fish, tea, coffee and alcohol. After the adjustments, the scientists at the University of Leeds found that each additional 25g portion of processed meat eaten per day was associated with a 44% increase in the risk of dementia from all causes. This intake was also associated with a 52% increased risk of Alzheimer’s disease.

However, each additional 50g portion of unprocessed meat eaten per day was linked to a 19% reduction in the risk of all-cause dementia and a 30% reduced risk of Alzheimer’s disease. The results for unprocessed poultry and total meat consumption were not statistically significant, the scientists said.

“Worldwide, the prevalence of dementia is increasing, and diet as a modifiable factor could play a role,” says Huifeng Zhang, a Ph.D. student at the School of Food Science and Nutrition at the University of Leeds, who was the lead researcher of the new study.

“Our research adds to the growing body of evidence linking processed meat consumption to increased risk of a range of nontransmissible diseases,” she added.

Reference: Medical News Today (March 29, 2021) “Dementia: 25 grams of processed meat per day may raise relative risk”

Tips for Caregiving during the Pandemic

The Harvard Health Letter provides some great tips in its recent article entitled “Caregiving during the pandemic” to make certain that a loved one is receiving the best care.

Direct Communication. If your elderly family member can communicate well, talk to them daily and remember that when you ask basic questions like “How are you feeling?” “Are you eating and drinking enough?” “Are you getting enough sleep?” However, that you may not get a straight answer. They may just tell you what you want to hear. Therefore, try to get a more realistic picture. Listen to how they sound on the call, and see if they sound different, sad, confused, or tired. Ask them how they’ve been spending their time and who they’ve seen that day. Look for clues that they may be getting sick.

Speak with The Staff. Ask questions. Start with the director of nursing or a caseworker. You can tell the staff you’re worried and that you may be asking more questions than usual. Find out how often they’re able to give you updates and have a list of questions that includes the following aspects of your loved one’s health and well-being.

  • Socialization. Ask if your family member is participating in activities or just staying in their room most of the time. If they’re not getting out, ask about a plan to get them back into a healthy social and physical routine.
  • Does the staff feel your senior is in generally good spirits, or is there an issue? Is this impacting their health or daily activities?
  • Physical Strength. Is your parent having difficulty rising from a chair or feeling unsteady when walking? Inactivity can diminish muscle strength and cause falls. Get them into an exercise routine or physical therapy.
  • Eating Habits. Are they eating and drinking enough, and what is the staff doing to encourage nutrition and hydration? A change in eating and drinking habits can mean a change in mood and should be addressed by a doctor.
  • Have any medications been added or eliminated recently, and for what reason?
  • Continence. Ask if your senior is able to get to the bathroom on time. If they’re incontinent, what’s the plan to deal with this issue?
  • Hygiene. Is your elderly loved one is able to bathe, brush his or her teeth and do other bathroom activities? If not, ask how often the staff is providing assistance.
  • Cognitive Skills. Ask if there’s been any change in your loved one’s ability to reason or have a conversation. In some cases, it might be linked to something fixable, like medication side effects or a urinary tract infection.

If You Find an Issue. Inform the staff about your concerns, especially if you suspect a new problem. Arrange a visit with a physician and try to be on the call if possible.

Social interaction is also important, so encourage loved ones to take part in activities at their facility. In the same fashion, try to connect with your loved one in any way possible. Make frequent visits if they’re allowed, drop off a care package, a card, flowers, or a picture from a grandchild. This is the best way to stave off feelings of isolation and loneliness that so many people in facilities experience.

Reference: Harvard Health Letter (March 2021) “Caregiving during the pandemic”

Does Blackjack Keep My Brain Sharp?

People who regularly play non-digital games, like card or board games, have been found to do better on memory and thinking tests in their 70s than those who don’t.

That’s according to a recent study from the University of Edinburgh in Scotland.

The Money Talk News article from April 2020 entitled “This Pastime Can Keep Your Brain Sharp as You Age” reports that there’s even better news: Those who suddenly increased game playing during their 70s also were more likely to maintain certain cognitive skills.

So, break out Monopoly or get some people together to play bridge or blackjack!

For the long-term study, which was published in The Journals of Gerontology, psychologists tested more than 1,000 people born in 1936 beginning at age 70 in skills such as memory, problem-solving, thinking speed and general thinking ability.

Researchers repeated the tests every three years, until the study participants were 79. At two ages — 70 and 76 — the participants also reported how frequently they played non-digital games, such as bingo, cards, chess or crosswords.

Those who played more games later in life saw less decline in thinking skills from age 70 to 79.

This protective effect was especially evident in memory function and thinking speed.

The researchers at the University of Edinburgh in Scotland noted that their findings were just the latest in a collection of evidence that supports a connection between engaging in activities throughout life and better thinking ability in old age.

In a university announcement about the study, co-author Ian Deary says:

“It would be good to find out if some of these games are more potent than others. We also point out that several other things are related to better cognitive aging, such as being physically fit and not smoking.”

So, chess anyone?

Reference: Money Talk News (April 23, 2020) “This Pastime Can Keep Your Brain Sharp as You Age”

 

How will an Apple Watch Help Study Dementia?

AI’s recent article entitled “Biogen will use Apple Watch to study symptoms of dementia,” says that this study will last for multiple years, and will launch later this year. People from a wide gamut of ages and cognitive performance levels will be asked to take part by Biogen.

They hope to find out if wearable devices like the Apple Watch could be used for long-term cognitive performance monitoring.

The ultimate objective is to develop digital biomarkers for cognitive performance monitoring over time, which may help identify early signs of mild cognitive impairment (MCI).

There are now serious delays in recognizing declines in cognitive health. This impacts about 15 to 20% of adults over the age of 65. The subtle onset of symptoms, including being easily distracted and memory loss, may take months or even years before it is observed as a cognitive decline by healthcare providers.

“The successful development of digital biomarkers in brain health would help address the significant need to accelerate patient diagnoses and empower physicians and individuals to take timely action,” said Biogen CEO Michel Vounatsos. “For healthcare systems, such advancements in cognitive biomarkers from large-scale studies could contribute significantly to prevention and better population-based health outcomes, and lower costs to health systems.”

Apple believes that this study “can help the medical community better understand a person’s cognitive performance, by simply having them engage with their Apple Watch and iPhone,” said Apple COO Jeff Williams. “We’re looking forward to learning about the impact our technology can have in delivering better health outcomes through improved detection of declining cognitive health,” he said.

The Apple Watch has been used for a number of health studies in the past, which are done with the research app. There have been studies to detect heart issues before they become an issue, as well as a hearing study monitoring ambient sound volumes, and activity and movement.

The dementia study is designed to ensure consumer privacy, control and transparency. It will emphasize data security.

The participants must complete a detailed consent from listing the collected data types and how they are used and shared before taking part. They can withdraw at any time.

Reference: AI (Jan. 11, 2021) “Biogen will use Apple Watch to study symptoms of dementia”

Is there a Blood Test for Alzheimer’s?

Independent experts are cautious of a new first blood test to help diagnose Alzheimer’s disease due to the fact that key test results haven’t been published, and the test has not been approved by the FDA. While it’s being sold under more general rules for commercial labs, they agree that a simple test that can be performed in a doctor’s office is long overdue.

NBC News’s recent article entitled “First blood test to help diagnose Alzheimer’s goes on sale” notes that more than five million people in the U.S. and millions more around the world have Alzheimer’s, the most common form of dementia. To be diagnosed with it, people will experience symptoms, such as memory loss plus evidence of a buildup of a protein in the brain called beta-amyloid.

Currently, the best way to measure beta-amyloid is a costly PET brain scan that usually is not covered by insurance. As a result, most people won’t get one and are left wondering if their problems are due to normal aging, Alzheimer’s, or another cause. However, this new blood test from C2N Diagnostics in St. Louis will try to fill that gap. The test isn’t designed for general screening or for people without symptoms. It is intended for those 60 and older, who are having thinking problems and are being evaluated for Alzheimer’s.

The test isn’t covered by insurance or Medicare, and C2N Diagnostics charges $1,250. However, it offers discounts based on income. Only a physician can order the test, and results come within 10 days. It’s sold in all but a handful of states in the U.S. and was just approved for sale in Europe.

The blood test measures two types of amyloid particles plus various forms of a protein that show if a person has a gene that increases risk for the disease. These factors are combined in a formula that includes age, and patients are given a score suggesting low, medium or high likelihood of having amyloid buildup in the brain. If the test scores the patient in the low category, it’s a good reason to look for other things besides Alzheimer’s. There are a number of things that can cause a person to be cognitively impaired, from vitamin deficiencies to medications.

The company has not published any data on the test’s accuracy, but the doctors have published on the amyloid research leading to the test. Company materials cite results comparing the test to PET brain scans, which is the current gold standard, in 686 people, ages 60-91, with cognitive impairment or dementia. If a PET scan showed amyloid buildup, the blood test also gave a high probability of that in 92% of cases and missed 8% of them, said the company’s CEO, Dr. Joel Braunstein. If the PET scan was negative, the blood test ruled out amyloid buildup 77% of the time. The other 23% got a positive result, but that doesn’t necessarily mean the blood test was wrong. The published research suggests it may see amyloid buildup before it’s noticeable on scans.

Braunstein said the company will seek FDA approval, and the agency has designated it for a faster review.

Reference: NBC News  (Nov. 30, 2020) “First blood test to help diagnose Alzheimer’s goes on sale”