Eli Lilly and Company has announced that its investigational drug, donanemab, has shown positive results in a Phase 3 clinical trial called TRAILBLAZER-ALZ 2. The study evaluated the safety and effectiveness of donanemab, a therapy that targets amyloid plaques, in people with early symptomatic Alzheimer's disease.
The primary endpoint of the study measured cognitive and functional decline using the Alzheimer's Disease Rating Scale (iADRS), which includes tasks such as managing finances, driving, engaging in hobbies, and conversing about current events. Donanemab met the primary endpoint and all secondary endpoints, showing significant clinical benefits.
Participants who received donanemab had a 35% slower decline in cognition and activities of daily living compared to those who received a placebo. Additionally, participants had a 40% less decline in their ability to perform activities of daily living and a 39% lower risk of progressing to the next stage of the disease compared to those who received a placebo.
Although the drug had side effects, including temporary swelling and microhemorrhages in some areas of the brain, these cases were mild to moderate and resolved or stabilized with appropriate management.
Eli Lilly and Company will proceed with global regulatory submissions to make donanemab available as soon as possible.
Dr. Paul Aisen spoke briefly about donanemab in his conversation for World Alzheimer's Day last year.
You can watch the entire conversation here.