Lilly and Banner Alzheimer’s Institute collaborate on planned Phase 3 prevention trial of donanemab

Eli Lilly and Company and Banner Alzheimer’s Institute announced a strategic research collaboration as part of the planned Phase 3, randomized, placebo-controlled study evaluating donanemab in participants at risk for cognitive and functional decline related to Alzheimer’s disease (TRAILBLAZER-ALZ 3). TRAILBLAZER-ALZ 3 will evaluate whether treatment with donanemab can slow the clinical progression of Alzheimer’s disease in trial participants.

As part of the collaboration, Banner will leverage its expertise and proven leadership in Alzheimer’s prevention trials, and support enrollment of trial participants with and without the e4 type of the apolipoprotein E (APOE4) gene through the Alzheimer’s Prevention Registry’s GeneMatch program. The collaboration will introduce a more virtual approach to the evaluation of Alzheimer’s prevention therapies. Lilly and Banner are committed to using the screening and treatment data as a shared scientific resource. Lilly remains the sole sponsor of the clinical trial and plans to begin enrollment later this year.

“This collaboration combines Lilly’s more than 30 years of dedication to Alzheimer’s research with Banner’s unique expertise and showcases our collective commitment to partner within the health care community to find potential treatments to end this devastating disease,” said Mark Mintun, M.D., vice president of pain and neurodegeneration, Lilly. “Our TRAILBLAZER-ALZ 3 trial will evaluate whether donanemab can prevent clinical progression in patients who have evidence of Alzheimer’s pathology, but don’t yet demonstrate clinical symptoms. While these types of trials are challenging to enroll and conduct, Lilly, together with Banner, is proud to undertake the opportunity to bring about this new study in an area of high unmet medical need.”

“We are excited about the chance to work with Lilly in the effort to find an effective Alzheimer’s prevention therapy as soon as possible, introduce novel ways to increase the size, speed, and ease of participating in Alzheimer’s prevention trials, and do so in ways that might benefit the entire field,” said Eric M. Reiman, MD, Banner Alzheimer’s Institute executive director and one of the study’s lead principal investigators. “We must do everything we can to find and support the availability of effective prevention therapies for this devastating disease, and this trial includes several potentially transformational elements to help in this endeavor.”

Donanemab is an investigational antibody that targets a modified form of beta amyloid called N3pG. Results from a Phase 2 study of donanemab were announced earlier this year. Donanemab is also being studied in the ongoing Phase 3 TRAILBLAZER-ALZ 2 study in early, symptomatic Alzheimer’s disease patients.