A new report estimates 6.5 million Americans have Alzheimer’s disease and more than 1 in 10 older adults have early stage memory or cognitive problems.
The Alzheimer’s Association report released Tuesday said 12-18% of adults 60 and over have “mild cognitive impairment,” a category of memory loss or cognitive problems that may be a precursor to dementia or caused by other medical or behavioral issues.
Distinguishing dementia from other medical causes of memory or cognitive problems remains difficult, experts say, but perhaps more important than ever with one controversial new Alzheimer’s drug available and others in late-stage clinical trials.
Many doctors and patients “think that it might be normal aging, and that’s something that needs to be addressed,” said Maria Carrillo, chief science officer of the Alzheimer’s Association. “They can be diagnosed, and a delay of a diagnosis can be harmful.”
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Common signs of memory loss might include forgetting a conversation or misplacing items. It also can surface as having trouble thinking during a conversation, navigating a once-familiar place or finishing daily tasks such as paying a bill, the report said.
It’s important for seniors to discuss memory loss or cognitive problems with their primary-care doctors, Carrillo said, because such lapses often are not related to dementia and can be reversed by behavior changes or medication. A person might be able to reverse such lapses through improved sleep habits or medication for depression or anxiety.
Still, a survey of 801 primary care doctors found 72% had difficulty differentiating normal aging from cognitive impairment. And 60% of doctors were unfamiliar with using tests such as spinal taps or brain scans that measure disease markers such as amyloid or tau – hallmarks of Alzheimer’s disease.
Past studies have shown at least half of people with Alzheimer’s disease or other forms of dementia don’t have the condition recognized or addressed before they die, said Dr. Pierre Tariot, a psychiatrist and director of Banner Alzheimer’s Institute in Phoenix.
Some health systems attempt to screen for memory lapses in older adults during routine doctor visits by incorporating cognitive tests and gathering details about a person’s history. But such screening might have limited value.
If such screening reveals cognitive impairment, Tariot said many doctors might not be prepared to advise a patient or caregiver about non-medical needs such as whether a person should continue to drive, go to work or communicate their condition with friends or families.
Advocacy groups pressure Medicare
The report comes as the Alzheimer’s Association and other patient groups ratchet up pressure on the Centers for Medicare and Medicaid Services over its preliminary decision to limit coverage of the first new Alzheimer’s drug in two decades to people enrolled in clinical trials. Medicare’s decision about Biogen’s Aduhelm and similar drugs in late-stage clinical trials looms large for pharmaceutical companies that have spent billions on the theory Alzheimer’s disease can be slowed by targeting the sticky clumps of beta-amyloid protein found in patients’ brains.
Biogen and other drug companies seeking Food and Drug Administration approval for a class of Alzheimer’s drugs known as monoclonal antibodies would be affected by Medicare’s preliminary decision to pay for the drugs only in clinical trials. Medicare will make a final decision in April.
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An advocacy group, UsAgainstAlzheimer’s, launched television and digital ads in Washington and Baltimore this week pressuring Medicare to change its preliminary decision. The organization will spend more than $1 million running ads until the federal agency makes a decision. Another organization, called the Alliance for Aging Research, planned a rally Tuesday in front of the U.S. Department of Health and Human Services office in Washington.
Despite public pressure from the drug companies and their allies, many doctors are reluctant to prescribe Aduhelm. The Food and Drug Administration granted accelerated approval last year based on two studies that yielded mixed results. The FDA’s outside expert advisers recommended against approval; three advisers quit when the agency approved the drug anyway.
“It’s frustrating for everyone,” said Dr. Keith Vossel, a neurologist and director of UCLA’s Mary S. Easton Center for Alzheimer’s Disease Research. “We just need to be a little patient. Until we can have more information about the efficacy and safety of these drugs, I do think it’s a little early for widespread use” of Aduhelm.
Vossel said UCLA does not list Aduhelm among the drugs it prescribes, although the drug is administered through clinical trials. Patients and caregivers who asked for prescriptions were less excited after Vossel explained the mixed clinical trial results and potential side effects such as brain swelling. Nearly all agreed the drug was not right for them, he said.
Still, Vossel believes it would be a mistake if Medicare preemptively restricted coverage for other amyloid-targeting drugs to post-approval clinical trials.
Beyond Aduhelm, Biogen is studying another amyloid-targeting drug called lecanemab and expects to have information from a late-stage clinical trial this year.
Pharmaceutical giant Roche expects to complete two late-stage clinical trials for its Alzheimer’s drug gantenerumab before the end of this year. Eli Lilly also expects to seek FDA approval before the end of the year for its drug donanemab.
“Each drug should be handled separately and independently,” Vossel said, “because the biology by which they work is different.”
Ken Alltucker is on Twitter as @kalltucker or can be emailed at alltuck@usatoday.com.