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”

What Is Elder Law?

With medical advancements, the average age of both males and females has increased incredibly. The issue of a growing age population is also deemed to be an issue legally. That is why there are elder law attorneys.

Recently Heard’s recent article entitled “What Are the Major Categories That Make Up Elder Law?” explains that the practice of elder law has three major categories:

Estate planning and administration, including tax issues
Medicaid, disability, and long-term care issues; and
Guardianship, conservatorship, and commitment issues.

Estate Planning and Administration. Estate planning is the process of knowing who gets what. With a will in place, you can make certain that the process is completed smoothly. You can be relieved to know that your estate will be distributed as you intended. Work with an experienced estate planning attorney to help with all the legalities, including taxes.

Medicaid, Disability, and Long-Term Care Issues. Elder law evolved as a special area of practice because of the aging population. As people grow older, they have more medically-related issues. Medicaid is a state-funded program that supports those with little or no income. The disability and long-term care issues are plans for those who need around-the-clock care. Elder law attorneys help coordinate all aspects of elder care, such as Medicare eligibility, special trust creation and choosing long-term care options.

Guardianship, Conservatorship, and Commitment Matters. This category is fairly straightforward. When a person ages, a disability or mental impairment may mean that he or she cannot act rationally or make decisions on his or her own. A court may appoint an individual to serve as the guardian over the person or as the conservator the estate, when it determines that it is required. The most common form of disability requiring conservatorship is Alzheimer’s, and a court may appoint an attorney to be the conservator, if there is no appropriate relative available.

Reference: Recently Heard (May 26, 2021) “What Are the Major Categories That Make Up Elder Law?”

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”

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 to Prepare for Health Care Costs in Retirement

A recent study of U.S. adults ages 50 to 64 found that about half (45%) had low confidence in their ability to afford health insurance during retirement.

Kiplinger’s recent article entitled “Are You Prepared for Health Care Costs While in Retirement?” says that the average 65-year-old couple in 2020 will need roughly $295,000 in today’s dollars during their retirement to cover health care expenses. And that’s not counting long-term care.

However, depending on your age, income, health, location, and Medicare eligibility, that figure could be much different. When long-term care is added, the expense for health care can increase dramatically. According to the U.S. Department of Health and Human Services, a person turning 65 today has almost a 70% chance of needing long-term care services in the senior years. Right now, the national average median cost is $8,821 for a private room in a nursing facility and $4,576 for a home health aide. Therefore, planning ahead is critical.

Let us look at what can you do to help save for retirement and health care savings.

Use a tax-free account for health care expenses. You can start budgeting for your health expenses by contributing to a Health Savings Account (HSA). If you have a high-deductible health care plan, your employer may offer an HSA. An HSA lets you contribute, while receiving a tax deduction. The money can be invested and grow tax deferred. If this money is eventually used for qualified medical expenses, the withdrawal is tax-free. This year, the IRS allows individuals to contribute $3,600 and families to contribute $7,200. This can add up to a significant sum, which can be a readu source of health care funds, when needed.

Prepare for long-term care. Medicare Part A covers skilled nursing care for a specific period after hospitalization. However, it doesn’t pay for custodial care for Alzheimer’s or other cognitive illnesses. That is why many people buy a long-term care (LTC) insurance policy. This policy will go beyond what your health insurance may cover, by reimbursing you for services needed to help you maintain your lifestyle, if age, injury, illness or a cognitive impairment creates difficulties for you in caring for yourself. With long-term care insurance, you can prevent your retirement and savings from being depleted, if this care is needed in the future. An LTC insurance policy provides your loved ones with greater options for providing care, while relieving them from full-time caregiver responsibilities.

It makes a difference where you live. Another factor that will have a big effect on how much you spend on health care is where you’re living in retirement. Traditional Medicare coverage is the same all over, but prescription coverage (Part D), Medicare Advantage (Part C), “Medigap” supplemental plans, and private insurance vary, depending on where you live. Plus, the costs of long-term care can vary by thousands of dollars from one state to another. If you’re currently living in a state where health care costs are higher, you might think about moving somewhere else in retirement.

Look at your age when you retire. A person can start collecting Social Security at age 62, but you can’t begin Medicare until age 65. If you choose to retire earlier than 65, there are a few options you can look at for health insurance. When you retire, you may choose to continue your employer’s coverage under COBRA for up to 18 months. However, your premiums will increase substantially because you’ll be paying the full premium without the employer’s contribution. If your spouse is still working and eligible for health insurance, you may be able to move to their plan. You can also buy an Affordable Care Act plan on a federal or state health insurance marketplace.

Reference: Kiplinger (Feb. 15, 2021) “Are You Prepared for Health Care Costs While in Retirement?”

What Do I Need to Know as a Caregiver for the Elderly?

Not everyone is cut out for assisting older people because the job requires a unique skillset and, more importantly, empathy.

Big Easy’s recent article entitled “6 Things to Consider as a Caregiver for the Elderly” says it can be hard to understand that a senior has become dependent on others, and being assisted in everyday tasks may even lead to compromises in their privacy. This can put a senior in stressful conditions that lead to anxiety. In that case, hiring a professional caregiver for the elderly may be the best option.

However, no matter your training, caring for an older person can still be challenging. Consider these six things to develop the best possible relationship with the elderly and to provide the best care.

Compassion. Being compassionate helps develop a better connection to the elderly person. This can frequently solve many behavioral problems and can make for a pleasant caregiving environment. Most older people have some physical or mental disability that keeps them from being independent. In some situations, being abandoned by their loved ones creates even more emotional damage. To help, be empathetic and kind to them in these difficult times. This can significantly help to decrease the emotional pain that accompanies old age and illness. Being compassionate is one of the most effective ways of delivering the best care possible in these situations.

Communication. If you have the ability to have natural and comfortable conversations with elderly patients, you can develop a tighter emotional bond with them. Healthy communication and conversations also can distract a senior from things that may be troubling them, which will not only benefit the patient but will also help you carry out your tasks more easily. You may also be called upon to interact with other family members or doctors, so good communication skills are required.

Safety. Safety is vital for the elderly, and the slightest negligence can become a matter of life and death for them. The most common types of injuries for older people are attributed to falls. It is also even more dangerous because their bones are weak and don’t heal quickly. Use extreme care when assisting seniors in slippery areas, like the bathroom. Take precautions, such as de-cluttering the house and eliminating tripping hazards. Most importantly, keep them under constant observation, especially those with mental illnesses.

Hygiene. Maintaining quality hygiene can be a challenge, especially if people are shy or want their privacy. Take bathing as an example: it’s not surprising that the elderly are embarrassed, when caregivers have to bathe them. Even so, you are tasked with maintaining their hygiene. If you don’t, it can lead to more health-related issues.

Medications. Most seniors take medication, some of which produce side effects, such as nausea or dizziness. As a caregiver, you should make certain that they are taking their medicines on time and watch for side-effects in the case of an emergency. Review their medications and administer the prescribed dosage at the right times yourself. This will also help those who forget to take their medicines without prompting.

You may have several challenging times throughout your career as a caregiver for the elderly, but empathy and compassion will help you considerably. You will create a better job experience and help the elderly with a very difficult phase of their life.

Reference: Big Easy (Dec. 10, 2020) “6 Things to Consider as a Caregiver for the Elderly”

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”

Could a Polar Bear Plunge Help with Dementia?

A “cold-shock” protein has been discovered in the blood of regular winter swimmers at London’s Parliament Hill Lido. The protein has been shown to retard the onset of dementia and even repair some of the damage it causes in mice, according to a report in the BBC’s recent article entitled “Could cold water hold a clue to a dementia cure?”

Professor Giovanna Mallucci, who runs the United Kingdom Dementia Research Institute’s Centre at the University of Cambridge, says the discovery could help scientists with new drug treatments that may help hold dementia at bay. The research, while encouraging, is at an early stage and focuses on the hibernation ability that all mammals retain, which is prompted by exposure to cold.

The link with dementia lies in the destruction and creation of synapses, which are the connections between cells in the brain. In the early stages of Alzheimer’s and other neuro-degenerative diseases, these brain connections are lost. Mallucci saw that brain connections are lost when hibernating animals, like bears, bed down for their winter sleep, but that roughly 20-30% of their synapses are culled as their bodies preserve precious resources for winter. When they awake in the spring, those connections are reformed.

The shock of entering cold water results in a significant increase in heart rate and blood pressure, which can cause heart attacks and strokes in those with underlying illnesses. This also creates a gasp reflex and rapid breathing, which can lead to drowning, if water is inhaled.

Don’t try a plunge without consulting a doctor.

When researching this treatment in mice, scientists found that levels of a “cold-shock” protein called RBM3 soared in the ordinary mice, but not in the others. This suggested RBM3 could be the key to the formation of new connections. Mallucci proved the link in a separate experiment which showed brain cell deaths in Alzheimer’s and prion disease could be prevented by artificially boosting RBM3 levels in mice. This was a major breakthrough in dementia research, and their findings were published in the scientific journal Nature.

Professor Mallucci contends that a drug which prompted the production of RBM3 might help slow—and possibly even partially reverse—the progress of some neuro-degenerative diseases in people. RBM3 hadn’t been seen in human blood, so the obvious next step was to find out whether the protein is present in humans.

It’s hard to get people to become hypothermic by choice, but Martin Pate and his group of Londoners who swim throughout the winter at the unheated open-air London Parliament Hill Lido pool voluntarily made themselves hypothermic on a regular basis, so he thought they’d be ideal subjects of a study.

The tests showed that a significant number of the swimmers had markedly elevated levels of RBM3. All of them become hypothermic, with core temperatures as low as 93.2^⸰F. A control group of Tai Chi participants who practice beside the pool but never actually swim, showed no increase in RBM3 levels nor had they experienced very low body temperatures.

The risks associated with getting cold outweigh any potential benefits, so cold water immersion isn’t a potential dementia treatment. The key is to find a drug that stimulates the production of the protein in humans and to show that it really does help delay dementia.

Reference: BBC (Oct. 19, 2020) “Could cold water hold a clue to a dementia cure?”

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