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Alzheimer's treatment built on Sarasota research heads toward FDA approval

Six scans of brain waves
Science Photo Library — ZEPHYR.
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Previous work by the Institute’s lead researchers has shown that certain genetic variations may cause or predispose humans to Alzheimer’s disease.

Sarasota's Roskamp Institute was the first to discover a protein that tends to form clumps in the brains of people with Alzheimer's. A new drug has been shown to reduce it.

Thirty years ago, doctors with Sarasota's Roskamp Institute were the first to discover genetic causes of Alzheimer’s Disease. Now, a drug built on their findings, is likely heading for FDA approval.

Beta-amyloid is a protein that tends to form clumps in the brains of people with Alzheimer's, and ultimately results in the sticky plaques that have become a hallmark of the disease.

Dr. Michael Mullen is Executive Director of the Roskamp Institute,and was one of the doctors who first made that connection.

"And so, the thought was that the amyloid was driving the disease in many ways and that if the amyloid could be removed, then that would be beneficial for patients," he said.

In a clinical study, a new drug called lecanemab -- a monoclonal antibody delivered through an IV injection -- has been shown to reduce the amount of amyloid in the brain. Mullen says lecanemab is not a cure, but an important first step in efforts to slow the progression of Alzheimer’s disease.

The Phase 3 trial followed about 1,800 people for 18 months.

Mullen says the drug showed a forty percent improvement in cognitive function compared with those who were administered
a placebo.

"You know, if the drug was given over several years, this might add up to quite a long time in pushing the disease out so that the rate of decline is decreased, and it's particularly activities of daily living that matter to patients and caregivers," he said.

The advocacy group, the Alzheimer’s Association, said in a written statement that "lecanemab will provide patients more time to participate in daily life and live independently. It could mean many months more of recognizing their spouse, children and grandchildren.”

The Food and Drug Administration is expected to decide whether to approve the treatment by early January.

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