Government health officials have approved the first new drug for Alzheimer’s disease in nearly 20 years. The Food and Drug Administration said it granted approval to the drug from Biogen based on results that seemed “reasonably likely” to benefit Alzheimer’s patients.

It’s the only drug that U.S. regulators have said can likely treat the underlying disease, rather than manage symptoms like anxiety and insomnia.

This is in spite of independent advisers feeling that it hasn’t been shown to help slow the brain-destroying disease.

The decision is certain to have disagreements among physicians, medical researchers and even patient groups.

The new drug, which Biogen developed with Japan’s Eisai Co., did not reverse mental decline, only slowing it in one study. The medication, aducanumab, will be marketed as Aduhelm and is to be given every four weeks.

Dr. Caleb Alexander, an FDA adviser who recommended against the drug’s approval, said he was “surprised and disappointed” by the decision.

“The FDA gets the respect that it does because it has regulatory standards that are based on firm evidence. In this case, I think they gave the product a pass,” said Alexander, a researcher at Johns Hopkins University.

Since the FDA’s approval researchers and pharma watchers have called the agency’s decision “disgraceful,” “a grave error” and a “dangerous precedent” that will end up “eroding confidence in the agency as a whole.”

The FDA’s top drug regulator acknowledged in a statement that “residual uncertainties” surround the drug, but said Aduhelm’s ability to reduce harmful clumps of plaque in the brain “is expected” to help slow dementia.

The FDA is requiring the drugmaker to conduct a follow-up study to confirm benefits for patients. If the study fails to show effectiveness, the FDA could pull the drug from the market.

Nearly 6 million people in the U.S. have Alzheimer’s.

Aducanumab (pronounced “addyoo- CAN-yoo-mab”) helps clear a protein linked to Alzheimer’s, called betaamyloid, from the brain.

People with dementia may experience increased levels of pain 16 years before their diagnosis, according to new research. The study, funded in part by NIA and published in Pain, is the first to examine the link between pain and dementia over an extended period.

Dementia and chronic pain both cause changes to the brain and can affect a person’s brain health. Although many people who have dementia also have chronic pain, it is unclear whether chronic pain causes or accelerates the onset of dementia, is a symptom of dementia, or is simply associated with dementia because both are caused by some other factor. The new study, led by researchers at Université de Paris, examined the timeline of the association between dementia and self-reported pain by analyzing data from a study that has been gathering data on participants for as many as 27 years.

The researchers used data from the Whitehall II study, a long-term study of health in British government employees. Participants were between the ages of 35 and 55 when they enrolled in the study. Using surveys conducted multiple times over the course of the study, the researchers measured two aspects of participant-reported pain: pain intensity, which is how much bodily pain a participant experiences, and pain interference, which is how much a participant’s pain affects his or her daily activities. They used electronic health records to determine whether (and when) participants were diagnosed with dementia.

Out of 9,046 participants, 567 developed dementia during the period of observation. People who were diagnosed with dementia reported slightly more pain as early as 16 years before their diagnosis, driven mostly by differences in pain interference. These participants reported steadily increasing pain levels relative to those who were never diagnosed with dementia. At the time of diagnosis, people with dementia reported significantly more pain than people without dementia.

The researchers note that, because the brain changes associated with dementia start decades before diagnosis, it is unlikely that pain causes or increases the risk of dementia. Instead, they suggest that chronic pain might be an early symptom of dementia or simply correlated with dementia. Future studies that include data on the cause, type, location, and characteristics of pain and the type and seriousness of a patient’s dementia could help define in more detail the link between dementia and pain.

This research was supported in part by NIA grants R01AG056477 and RF1AG062553.

People with mental disorders in youth tend to have signs of accelerated aging in midlife and a higher risk of developing other diseases and of dying earlier, according to a pair of related studies supported in part by NIA. The findings, which appeared in JAMA Network Open and in JAMA Psychiatry, suggest that improving individuals’ mental health could enhance their overall health and extend their lives. The respective studies were led by researchers at Duke University and the University of Michigan.

Increasing evidence suggests that biological aging is best understood as a network of interacting genetic and environmental factors. As we age, our body’s repair mechanisms decline, contributing to multi-system impairment and diseases that are more common in late life, such as cancer, diabetes, cardiovascular disease, and brain diseases, such as dementia. But less is known about how early life experiences influence disease onset many years later.

In the two new studies, the researchers followed up on the observation that people with poor mental health when they are young are more likely to have age-related diseases when they are older. To better characterize the nature of this connection, they analyzed health and mortality data from large numbers of individuals in New Zealand collected over the course of decades.

For the JAMA Network Open study, the researchers examined data from more than 2 million New Zealanders aged 10 to 60 years old across the subsequent 30 years, or until death. Their analysis showed that people who had been admitted to hospitals for mental health problems — including substance use, psychotic, mood, and behavioral disorders — tended to have other diseases such as cancer, diabetes, and cardiovascular disease at a younger age, and to die earlier — than those who did not have mental health problems early in life. People with a history of mental illnesses were also more likely to develop more chronic health conditions and to be hospitalized more often and for longer periods. These patterns were seen in both men and women, and across the lifespan.

In the study published in JAMA Psychiatry, the researchers explored the idea that accelerated biological aging might drive the early onset of other health conditions in people who had previously experienced mental health problems. They used data from the Dunedin Study, which monitored the health of about 1,000 people in New Zealand from age 3 to 45.

The results showed that at middle age, people with a history of mental health problems were aging at a faster pace, as measured by a panel of biomarkers and assessments of sensory, motor, and cognitive function. The connection was significant even after the researchers controlled for other factors that could potentially speed the aging process such as smoking, being overweight, low socioeconomic status, having a preexisting health condition, or a history of poor childhood health or maltreatment.

Together, the findings suggest that treating mental disorders in young people not only improves their well-being but may also forestall the onset of health problems later on. The results also offer the possibility that further research on how adverse psychological states hasten the aging process could lead to strategies to slow its progression, possibly enabling people to stay healthy for longer.

by Erin Bryant From NIH Research Matters

Changes in sleep patterns are common in people with Alzheimer’s disease and other dementias. They may wake up often during the night and find it hard to get back to sleep. These sleep problems are thought to result from brain changes caused by the disease that affect the sleep-wake cycle.

Studies have suggested that sleep patterns earlier in life may contribute to later dementia risk. Both insufficient sleep and sleeping longer than average have been linked to a greater likelihood of developing dementia. However, it has been hard to determine whether these sleep changes contribute to the disease or simply reflect early symptoms.

Many of the studies on sleep and dementia risk have followed participants for less than a decade and focused on people over the age of 65. A study led by Dr. Séverine Sabia of Inserm and University College London examined how sleep patterns earlier in life may affect the onset of dementia decades later.

The study was supported in part by NIH’s National Institute on Aging (NIA). Findings appeared in Nature Communications on April 20, 2021.

The researchers examined data from nearly 8,000 people in Britain starting at age 50. Participants were assessed on a wide variety of measures, including being asked on six occasions between 1985 and 2016 how many hours they slept a night. To assess the accuracy of this self-reporting, some of the participants wore accelerometers to objectively measure sleep time. Over the course of the study, 521 participants were diagnosed with dementia, at an average age of 77.

Analysis of the data showed that people in their 50s and 60s getting six hours of sleep or less were at greater risk of developing dementia later. Compared to those getting normal sleep (defined as 7 hours), people getting less rest each night were 30% more likely to be diagnosed with dementia.

The researchers adjusted their model to account for other factors known to influence sleep patterns or dementia risk, including smoking, physical activity, body mass index, and medical conditions like diabetes and heart disease. They also separated out people with mental illnesses like depression, which are strongly linked to sleep disturbances.

The findings suggest that short sleep duration during midlife could increase the risk of developing dementia later in life. More research is needed to confirm this connection and understand the underlying reasons.

“While we cannot confirm that not sleeping enough actually increases the risk of dementia, there are plenty of reasons why a good night’s sleep might be good for brain health,” Sabia says.

This research was supported in part by NIA grants R01AG056477 and RF1AG062553.

Reference: Association of sleep duration in middle and old age with incidence of dementia.

The Foundation Assisting Seniors (FAS) is proud to announce the Celebrate a Senior™ program, a nationwide fundraising program to show appreciation and honor seniors across the country. Celebrate a Senior™ will directly support two national programs, HowRU™ and the Medication Reminder program which will continue to serve seniors across the U.S. at no-cost for years to come.

“We are thrilled to launch this program for seniors and their loved ones across the nation,” said Carol Chapman, president of FAS. “Now more than ever, we need to cherish our seniors and the Celebrate a Senior™ program provides an opportunity for loved ones to pay tribute to those 50 and older in their lives while supporting a service organization that provides peace of mind to seniors and their families.”

The HowRU™ program was created for seniors living alone, which provides a daily safety and check-in call to participants. The Medication Reminder Program also provides daily calls to subscribers to remind them to take their medication, both which are free and available nationwide.

The Celebrate a Senior™ program has two donation tiers. The first tier is between $25 and $99. For this tier, FAS will send the honoree a certificate signed by chair and president of FAS, includes donor and recipient names and honoree will be listed on the FAS website. The second- tier donation is any donation over $100. The honoree will receive a hand painted six-inch tile with the honoree’s name and will be mounted on the Celebrate a Senior™ wall at FAS headquarters and honoree will be listed on the FAS website.

If interested, you can donate online at FoundationAssistingSeniors.org/SeniorAppreciationProgram

Language sample analysis may help predict future Alzheimer’s disease in people who are cognitively normal, suggesting that language patterns may be an early, detectable biomarker for the disease. Published in EClinicalMedicine, researchers at IBM Thomas J. Watson Research Center and Pfizer Worldwide Research and Development analyzed written language samples and were able to predict Alzheimer’s disease more than seven years before the diagnosis.

For the study, researchers used data from 270 participants in the long-running, NIH-funded Framingham Heart Study: 190 participants were in the training set and 80 participants were in the test set. The training set was used to develop the linguistic markers via a type of machine learning called automated linguistic analysis. The test set, determined by those participants whose data had been reviewed thoroughly by a panel of experts to assess their Alzheimer’s disease status, was used to assess the predictive performance of those linguistic markers in an independent sample.

In particular, for the test set, half of the 80 subjects had developed Alzheimer’s-like symptoms by age 85 (cases) and half did not (controls). Each of the 270 participants had performed a written picture analysis task when they were cognitively normal. For the training set, the researchers identified 87 language characteristics from the writing samples. They then used models to predict the future development of Alzheimer’s disease by assessing language performance.

Researchers found that language patterns such as writing short and simple phrases, repeating and misspelling words, and skipping punctuation were associated with future onset of Alzheimer’s. The language pattern analysis was about 70% accurate in predicting who developed Alzheimer’s disease. Additionally, combining language sample analysis with more traditional clinical data models, such as neuropsychological test scores, demographic and genetic information, and medical history, increased prediction accuracy from 59% to 69% when language was also included.

The researchers noted that exploring the relationships of linguistic and non-linguistic variables, along with verbal language patterns, may further the development of non-invasive tests for the early detection of Alzheimer’s.

The Framingham Heart Study Consortium data used in this research was supported in part by NIA grants R01AG016495 and R01AG008122.

These activities relate to NIH’s AD+ADRD Research Implementation Milestone 9.H, “Launch research programs to develop and validate sensitive neuropsychological and behavioral assessment measures to detect and track the earliest clinical manifestations of AD and AD-related dementias.”

Reference: Eyigoz E, et al. Linguistic markers predict onset of Alzheimer’s disease. EClinicalMedicine. 2020;28:100583. doi: 10.1016/j.eclinm.2020.100583.

As you age, you may have concerns about the increased risk of dementia. You may have questions, too. Are there steps I can take to prevent it? Is there anything I can do to reduce my risk? There are currently no approaches that have been proven to effectively treat or prevent Alzheimer’s disease and related dementias. However, as with many other diseases, there may be steps you can take to help reduce your risk.

Race and gender are also factors that influence risk. Research shows that African Americans, American Indians, and Alaska Natives have the highest rates of dementia, and that risk factors may differ for women and men. Researchers are investigating what’s behind these differences.

Although there is no effective treatment or proven prevention for Alzheimer’s and related dementias, in general, leading a healthy lifestyle may help address risk factors that have been associated with these diseases.

Control high blood pressure. High blood pressure, or hypertension, has harmful effects on the heart, blood vessels, and brain, and increases the risk of stroke and vascular dementia. Treating high blood pressure with medication and healthy lifestyle changes, such as exercising and quitting smoking, may help reduce the risk of dementia.

Manage blood sugar. Higher than normal levels of blood sugar, or glucose, can lead to diabetes and may increase the risk of heart disease, stroke, cognitive impairment, and dementia. Making healthy food choices, getting regular exercise, stopping smoking, and checking glucose levels can help manage blood sugar.

Maintain a healthy weight. Being overweight or obese increases the risk for related health problems such as diabetes and heart disease. Being active and choosing healthy foods can help maintain a healthy weight.

Eat a healthy diet. Aim for a mix of fruits and vegetables, whole grains, lean meats and seafood, unsaturated fats such as olive oil, low-fat or nonfat dairy products, and limited other fats and sugars.

Keep physically active. Physical activity has many health benefits, such as helping to prevent being overweight and having obesity, heart disease, stroke, and high blood pressure. Aim to get at least 150 minutes of moderate-intensity physical activity each week.

Stay mentally active. Lots of activities can help keep your mind active, including reading, playing board games, crafting or taking up a new hobby, learning a new skill, working or volunteering, and socializing.

Stay connected with family and friends. Connecting with people and engaging in social activities can prevent social isolation and loneliness, which are linked to higher risks for cognitive decline and Alzheimer’s disease.

Treat hearing problems. Hearing loss may affect cognition and dementia risk in older adults and can make it more difficult to interact with others. Protect your ears from loud sounds to help prevent hearing loss and use hearing aids if needed.

Take care of your mental and physical health. This includes getting your recommended health screenings, managing chronic health issues such as depression or high cholesterol, and regularly checking in with your health care provider.

Sleep well. Sleeping well is important for both your mind and body. Try to get seven to eight hours of sleep each night. Talk with your doctor if you are not getting enough sleep, sleeping poorly, or think you may have a sleep disorder.

Symptoms of frontotemporal disorders vary from person to person and from one stage of the disease to the next as different parts of the frontal and temporal lobes are affected. In general, changes in the frontal lobe are associated with behavioral symptoms, while changes in the temporal lobe lead to language and emotional disorders.

Symptoms are often misunderstood. Family members and friends may think that a person is misbehaving, leading to anger and conflict. For example, a person with bvFTD may neglect personal hygiene or start shoplifting. It is important to understand that people with these disorders cannot control their behaviors and other symptoms. Moreover, they lack any awareness of their illness, making it difficult to get help.

Behavioral Symptoms of Frontotemporal Disorders

Problems with executive functioning—Problems with planning and sequencing (thinking through which steps come first, second, third, and so on), prioritizing (doing more important activities first and less important activities last), multitasking (shifting from one activity to another as needed), and self-monitoring and correcting behavior.

Perseveration—A tendency to repeat the same activity or to say the same word over and over, even when it no longer makes sense.

Social disinhibition—Acting impulsively without considering how others perceive the behavior. For example, a person might hum at a business meeting or laugh at a funeral.

Compulsive eating—Gorging on food, especially starchy foods like bread and cookies, or taking food from other people’s plates.

Utilization behavior—Difficulty resisting impulses to use or touch objects that one can see and reach. For example, a person picks up the phone while walking past it when the phone is not ringing and the person does not intend to place a call.

Language Symptoms of Frontotemporal Disorders

Aphasia—A language disorder in which the ability to use or understand words is impaired but the physical ability to speak properly is normal.

Dysarthria—A language disorder in which the physical ability to speak properly is impaired (e.g., slurring) but the message is normal.

People with PPA may have only problems using and understanding words or also problems with the physical ability to speak. People with both kinds of problems have trouble speaking and writing. They may become mute, or unable to speak. Language problems usually get worse, while other thinking and social skills may remain normal longer before deteriorating.

Apathy—A lack of interest, drive, or initiative. Apathy is often confused with depression, but people with apathy may not be sad. They often have trouble starting activities but can participate if others do the planning.

Emotional changes—Emotions are flat, exaggerated, or improper. Emotions may seem completely disconnected from a situation or are expressed at the wrong times or in the wrong circumstances. For example, a person may laugh at sad news. Pseudobulbar affect, a condition of sudden, frequent outbursts of crying or laughing that cannot be controlled, may occur and is treatable.

Social-interpersonal changes—Difficulty “reading” social signals, such as facial expressions, and understanding personal relationships. People may lack empathy—the ability to understand how others are feeling—making them seem indifferent, uncaring, or selfish. For example, the person may show no emotional reaction to illnesses or accidents that occur to family members.

The links between sugar, obesity and addiction; an 80th birthday retrospective of music icon Neil Diamond; California’s medicinal herbs and the power of positive psychology on the aging process are all topics in CSU Channel Islands Osher LifeLong Learning Program (OLLI). “Taste of OLLI” consists of 25 two-hour a day courses that will enable adults aged 50 plus to sample OLLI’s university level courses taught by faculty and experts from many different walks of life. Registration for these affordable courses begins May 24. See the list of courses and register by visiting go.csuci.edu/OLLI.”