Inside the plan to diagnose Alzheimer’s in people with no memory problems — and who stands to benefit

Melody Petersen | Los Angeles Times (TNS)

In a darkened Amsterdam conference hall this summer, a panel of industry and academic scientists took the stage to announce a plan to radically expand the definition of Alzheimer’s disease to include millions of people with no memory complaints.

Those with normal cognition who test positive for elevated levels of certain proteins that have been tied to Alzheimer’s — but not proven to cause the disease — would be diagnosed as having Alzheimer’s Stage 1, the panel members explained.

Even before the presentation ended, attendees in the packed hall were lining up behind microphones to ask questions, according to video of the event.

“I’m troubled by this,” Dr. Andrea Bozoki, a University of North Carolina neurologist, told the panel. “You are taking a bunch of people who may never develop dementia or even cognitive impairment and you’re calling them Stage 1. That doesn’t seem to fit.”

Under the proposal, tens of millions of Americans with normal cognition would test positive for abnormal levels of amyloid or tau, the two proteins the tests look for, and the majority of them may never be diagnosed with dementiastudies suggest. A 60-year-old man who tests positive, for example, is estimated to have a 23% risk of developing dementia in his lifetime.

Criticism of the plan has intensified since it was unveiled in July at the international conference attended by 11,000 doctors and scientists. But the panel, organized by the nonprofit Alzheimer’s Association, is continuing its push to extend the diagnosis to people who have no problem recalling events or what day it is — and convince skeptics that Alzheimer’s symptoms aren’t necessary to have the disease.

Panel members argue that the earlier patients get help, the more effective it might be. The availability of new drugs for patients with early Alzheimer’s symptoms has spurred them into action now, they say.

The plan could be approved by the panel and published in a medical journal early this year, association officials said. Such a move is likely to be influential: A similar proposal in 2018 that was put forth to help guide research on experimental Alzheimer’s medications was quickly adopted by the Food and Drug Administration and is frequently cited by doctors, scientists and health insurers.

Standing to benefit are the pharmaceutical and medical testing companies who employ seven members of the 20-person panel. At least seven more members of the panel are academics who receive money from those companies for consulting or research. Panelists reached by The Times said the funding did not influence their decisions.

Four other scientists who are outside advisors to the panel are executives from Eisai and Biogen, the makers of two new medicines for Alzheimer’s patients, and Eli Lilly and Genentech, which are developing similar drugs.

The American Geriatrics Society called the panel members’ financial ties to industry “wholly inappropriate.” In an analysis of the proposal, the society warned the proposal could lead to overdiagnosis of Alzheimer’s and subject people to treatments with “limited benefit and high potential for harm.”

Others said the plan was premature at best.

“I think this is untested, uncharted territory,” said Dr. Madhav Thambisetty, a senior researcher at the National Institute of Aging. “I’m not at that stage where I would be able to make a diagnosis of Alzheimer’s disease in somebody who’s cognitively normal based on the presence of a single biomarker.”

Under the proposal, people with no memory problems who test positive for abnormal levels of amyloid or tau proteins would be classified as Stage 1. They would move to Stage 2 if they begin to experience “neurobehavioral difficulties” such as depression, anxiety or apathy — symptoms often unrelated to Alzheimer’s — even if the patient’s cognition is unchanged.

Stage 3 would be for those with mild cognitive impairment, while Stages 4 through 6 would describe patients with mild, moderate or severe dementia.


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