Potential New Alzheimer’s Treatment Reported to Slow Cognitive Decline
The clinical trial results for lecanemab, a drug targeting early Alzheimer’s disease (mild cognitive impairment or mild dementia due to Alzheimer’s disease), were released yesterday. They reported a moderate slowing of cognitive decline in patients by 25% through the removal of amyloid-beta (Aβ) in the brains of people who received it compared to a placebo. Findings were shared at the Clinical Trials on Alzheimer’s Disease conference in San Francisco and published in the peer-reviewed medical journal New England Journal of Medicine.
Historic topline results—the first to show a statistically significant slowing of cognitive decline by targeting amyloid—released in September by pharmaceutical companies Eisai and Biogen were widely viewed as promising and generated much anticipation surrounding the potential for an FDA-approved treatment in early Alzheimer’s disease.
“BrightFocus Foundation remains encouraged by this potential new treatment and hopeful for the millions of people devastated by a disease with no cure,” said Diane Bovenkamp, PhD, Vice President, Scientific Affairs, BrightFocus Foundation. “Early detection and treatment are critical in the fight against Alzheimer’s disease—by slowing Alzheimer’s at the outset, we can more effectively target and treat the underlying pathology of the disease through a multi-pronged approach.”
An 18-month global phase 3 trial involving 1,795 people 50-90 years old with early Alzheimer’s disease and mild cognitive impairment or mild dementia due to Alzheimer’s disease was conducted. The drug was administered intravenously to participants randomized to receive the drug every two weeks.
With 20% of trial participants classified as “non-white,” and men and women reported to have near equal gender representation, the diversity of participants in the study—conducted across North America, Europe, and Asia—helps to better account for sex-based and racial differences that more closely mirror a global population.
“The inclusive clinical trial design and significance achieved indicates that future clinical trials should use similar models to better provide treatments for all populations and decrease health disparities,” Dr. Bovenkamp added. “If approved, health care providers and affected individuals will need guidance to determine who is an ideal candidate for lecanemab and how to best detect potential side effects as outlined in the published findings.”
An FDA decision on accelerated drug approval is expected by Jan. 6, 2023. While adverse events were reported during the trial and the study states that longer trials are warranted to determine the efficacy and safety of lecanemab, many experts, affected individuals, and caregivers remain heartened by findings that the drug could help delay disease progression and maintain quality of life.
About BrightFocus Foundation
BrightFocus Foundation is a premier nonprofit funder of research to defeat Alzheimer’s, macular degeneration, and glaucoma. Through its flagship research programs—Alzheimer’s Disease Research, National Glaucoma Research, and Macular Degeneration Research—the Foundation is currently supporting a $75 million portfolio of 287 scientific projects worldwide. BrightFocus has awarded nearly $275 million in groundbreaking medical research funding since inception and shares the latest research findings, expert information, and English/Spanish disease resources to empower the millions impacted by these devastating diseases. Join our community at brightfocus.org.