Donanemab expected to be submitted soon for FDA approval
Providence, RI – Eli Lilly and Company announced on May 3 positive results of the TRAILBLAZER-ALZ 2 Phase 3 study showing that the investigational drug donanemab significantly slowed cognitive and functional decline in people with early symptomatic Alzheimer's disease (AD).
In a press release announcing the study findings, Eli Lilly reported that the study showed a 35% slowing of clinical and functional decline, and that 47% of participants on donanemab showed no decline on CDR-SB (a key measure of disease severity at one year), compared to 29% of participants on placebo. Participants also had a 40% less decline in the ability to perform activities of daily living at 18 months and a 39% lower risk of progressing to the next stage of disease compared to placebo.
“The TRAILBLAZER Phase 3 results represent a major advance in the treatment of AD,” said Stephen Salloway, MD, MS, founding director of the Memory and Aging Program and of Neurology at Butler Hospital and the Martin M. Zucker professor of Psychiatry and Human Behavior and professor of Neurology at the Warren Alpert Medical School of Brown University. Dr. Salloway was the principal investigator for the Phase 2 study of donanemab at Butler Hospital and was a co-author of the publication of that study in the New England Journal of Medicine.
“We are proud to have played a role in its development here at the Memory and Aging Program, and we salute Eli Lilly and the many other organizations that have dedicated decades to AD research,” Dr. Salloway said. “Each study and every finding along the way has been a stepping stone leading up to this moment. We’re excited that this treatment is likely to provide not only a great new hope for people living with AD today but continued new opportunities to build on in the future.”
Donanemab works by targeting the amyloid plaque build-up in the brain that is associated with the development of AD. The TRAILBLAZER Phase 3 study showed that, in addition to slowing cognitive and functional decline, donanemab produced significant reductions in brain amyloid plaque levels as early as 6 months after initiating treatment, with many patients reaching amyloid levels considered negative for pathology, as observed using amyloid positron emission tomography (PET) brain scans.
“The results of this study build on the positive results from previous studies, including the study of lecanemab which is currently under review for full approval from the FDA,” Dr. Salloway said. “The TRAILBLAZER Phase 3 study also included important new innovations, such as using amyloid and tau PET scans to accurately identify individuals with early stages of the disease. It also implemented rules for stopping the medication once amyloid levels were considered negative for Alzheimer’s based on PET findings.”
Dr. Salloway says that taken together, these studies show that lowering amyloid plaque can improve the quality of life for patients with early Alzheimer’s disease. However, he notes that lowering amyloid plaque can also come with side effects, most notably temporary fluid shifts and swelling in the brain, called amyloid-related imaging abnormalities, or ARIA. ARIA is usually transient and without symptoms, but can be more serious or rarely, fatal.
Patients and families need to weigh the potential benefits of donanemab against the risks, and providers need to carefully monitor patients to safely manage this potential side effect. The Butler Memory and Aging Program is participating in ALZ-NET, a new network developed by the Alzheimer’s Association and the American College of Radiology to help clinicians monitor the safety and efficacy of new disease-modifying medications for Alzheimer’s such as donanemab.
The Memory & Aging Program (MAP) at Butler Hospital is a worldwide leader in Alzheimer’s disease research and a local Rhode Island partner in the fight against Alzheimer’s and other forms of dementia. An affiliate of The Warren Alpert Medical School of Brown University, MAP has a 25-year history of excellence in Alzheimer’s clinical care, training, and research aimed at developing new and better ways to detect, treat, and someday even prevent Alzheimer’s. Individuals who wish to be considered for participation in current and future research studies and clinical trials conducted at the Memory and Aging Program for the prevention and treatment of Alzheimer’s disease can join the program’s Alzheimer’s Prevention Registry at Butler Hospital online at butler.org/ALZregistry or by calling (401) 455-6402. For more information visit butler.org/memory and follow on Facebook and Twitter.
About Butler Hospital
Butler Hospital, a member of Care New England, is the only private, nonprofit psychiatric and substance abuse hospital serving adults, seniors, and adolescents in Rhode Island and southeastern New England. Founded in 1844, it was the first hospital in Rhode Island and has earned a reputation as the leading provider of innovative psychiatric treatments in the region. The Major Affiliated Teaching Hospital for Psychiatry and Behavioral Health at The Warren Alpert Medical School of Brown University, Butler is recognized worldwide as a pioneer in conducting cutting-edge research. For more information, visit butler.org.