CLEVELAND — Many have been waiting to see the trial data now published in the New England Journal of Medicine and it appears the longer the patient takes Lecanemab, the better the benefit.
Lecanemab is a monoclonal antibody drug targeting abnormal clumps of beta-amyloid plaque on the brain. That's a sticky protein believed to contribute to cognitive decline.
All of the trial participants had early onset Alzheimer's disease. Research showed the drug appeared to slow cognitive and functional decline by 27% however, there were some safety concerns.
14% of those taking the drug had serious adverse reactions compared to 11.3% on the placebo. The adverse reactions included issues with the I.V. Infusion delivery system, brain swelling and brain bleeding. There were six deaths reported in the group taking the drug compared to seven deaths in the placebo group.
The trial found that those patients who were on the drug for at least 18 months had better outcomes.
The manufacturer of lecanemab has applied for an accelerated approval pathway. The FDA will decide whether to grant it in January.
Earlier this month, we told you the story of Jerry Fair and his wife Debra, high school sweethearts who have been married for 45 years. At 62, Jerry looked forward to retirement, never thinking a disease would derail his plans.
Doctors diagnosed Jerry with early onset Alzheimer's disease in 2019. He became the first patient enrolled in the lecanemab clinical trial at Cleveland Clinic.
"My suspicion is that he has gotten the medication the whole entire time. I feel like with a diagnosis coming up on four years ago, we would have seen more of a decline than what we're seeing right now," Debra says.