In a study dubbed Trailblazer-Alz, Eli Lilly and Company have completed Phase II of their clinical trial examining the antibody, Donanemab, for its efficacy in slowing the decline of patients with early symptomatic Alzheimer’s disease.
Donanemab is designed to target a modified beta-amyloid, N3pG, and appears to aid in the clearance of amyloid plaque. The patients given the treatment showed an 84 centiloid decrease of amyloid plaque after 76 weeks, after beginning with a baseline of 108 centiloids. (Less than 25 centiloids would place patients in a normal range for a negative amyloid scan.)
The study’s results are promising, as they showed a significant level of amyloid plaque clearance. The trial’s clinical protocol involved multiple centers, and examined 272 patients using a randomized, placebo controlled, double-blind method. The study demonstrated a slowed decline of 32% when compared to the groups receiving the placebo. This meets the primary endpoint for 76 week changes as described in the Integrated Alzheimer’s Disease Rating Scale, and the treatment made consistent progress in all preregistered secondary endpoints such as those looking at cognition and mental function. Though, the study has not found nominal statistical significance on every secondary endpoint.
In an interview with Biospace Lilly’s chief scientific officer said: “In conjunction with our expertise in amyloid and tau imaging, this allowed us to conduct a trial to test if reducing amyloid plaques in Alzheimer’s patients to levels seen in scans of healthy individuals could result in clinically meaningful slowing of cognitive decline.”
The company intends to advance its research in a follow-up trial, Trailblazer-Alz 2.
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