Alzheimer’s Disease is the leading cause of dementia. Recently, the FDA had a group of independent experts review research on a new medication for this disease.
It is a distinct form of an antibody that attacks the protein (beta-amyloid) that builds up in the brain and interferes with brain function in people with Alzheimer’s.
This antibody is donanemab made by Eli Lilly company. There are two different antibody medications already on the market for slowing the progression of the disease. If approved, Eli Lilly’s product would be the third.
The research reviewed by the independent experts included less increase in amyloid deposits in the brain at 76 weeks on the drug compared to placebo.
The experts also compared cognitive test results at 76 weeks compared to placebo. The research subjects on donanemab had less decline than those on placebo.
Like all medicines, this one has side effects. The treatment was stopped in 8% of subjects on the active medicine compared to 4% on placebo as a result of adverse effects.
The Alzheimer’s Association looked at the research and concluded that “donanemab significantly slowed cognitive and functional decline in people living with early symptomatic Alzheimer’s disease (either mild cognitive impairment or mild dementia).”
The Association points out that this medicine is “not a cure” for Alzheimer’s disease, but it may “allow people to have more time to participate in daily life and live independently.”
Although the independent experts unanimously recommended approval of donanemab, the final decision is up to the FDA. They will have to decide whether the benefits exceed the risks. The risks can be serious including brain swelling or bleeding in the brain.
Another issue that society has to face is an economic one. All of the antibody treatments for Alzheimer’s disease are very expensive. Since a majority of people who develop Alzheimer’s disease are at the age for Medicare, the financial burden falls mainly on this government program.
Given the seriousness of Alzheimer’s disease, there is great interest in treatments that slow down its progression. Of course, a cure would be best.
Peter M. Hartmann, MD
Family Medicine & Psychiatry
Health and Culture 