Phase 3 Trial of Donanemab for Alzheimer Disease Will Use Digital Tools for Enrollment

 The phase 3 TRAILBLAZER-ALZ 3 study (NCT04437511) will evaluate whether treatment with donanemab (LY3002813; Eli Lilly, Indianapolis, IN) can slow the clinical progression of Alzheimer disease (AD). 

Individuals with and without the ε4 type of the apolipoprotein E (APOE4) gene will be eligible to participate through the Alzheimer Prevention Registry's GeneMatch program. The study’s primary goal is to find a more virtual approach to the evaluation of AD prevention therapies. The 2 collaborators are dedicated to using the screening and treatment data as a shared scientific resource. 

"This collaboration combines Lilly's more than 30 years of dedication to Alzheimer 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, MD, 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 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 prevention therapy as soon as possible, introduce novel ways to increase the size, speed, and ease of participating in Alzheimer prevention trials, and do so in ways that might benefit the entire field," said Eric M. Reiman, MD, Banner Alzheimer Institute executive director and a lead principal investigator. "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 amyloid called N3pG. Donanemab is being studied in the ongoing phase 3 TRAILBLAZER-ALZ 2 study in early, symptomatic individuals with AD.