DONANEMAB is an Alzheimer's drug developed by Eli Lilly that works by lowering levels of proteins in the brain that are thought to be responsible for the progression of Alzheimer's. In the trial, patients received donanemab until scans showed their brains were clear of those proteins, called beta-amyloid.
In May 2023, Eli Lilly and Company announced positive results from the TRAILBLAZER-ALZ 2 Phase 3 study showing that donanemab significantly slowed cognitive and functional decline in people with early symptomatic Alzheimer's disease. Donanemab is a monoclonal antibody that targets amyloid plaques, which are thought to play a role in the development of Alzheimer's disease.
The study enrolled 1,625 people with early Alzheimer's disease. Participants were randomly assigned to receive either donanemab or a placebo. The primary outcome of the study was change from baseline until 18 months on the integrated Alzheimer's Disease Rating Scale (iADRS). The iADRS is a composite measure of cognition and activities of daily living.
Donanemab met the primary endpoint of the study, with a 35% slowing of clinical and functional decline compared to placebo. Donanemab also showed a 40% reduction in the decline in the ability to perform activities of daily living.
The safety profile of donanemab was generally favorable. The most common side effects were headache, nausea, and constipation. There were no serious safety concerns identified in the study.
The results of the TRAILBLAZER-ALZ 2 study are a significant advance in the treatment of Alzheimer's disease. Donanemab is the first drug to show a significant slowing of cognitive and functional decline in people with early Alzheimer's disease. The drug is currently under review by the FDA, and it is expected to be approved in 2023.
If approved, donanemab would be a welcome addition to the treatment options for Alzheimer's disease. The drug has the potential to slow the progression of the disease and improve the quality of life for people with Alzheimer's and their families.
What's Next for Donanemab?
The FDA is currently reviewing the data from the TRAILBLAZER-ALZ 2 study. The agency is expected to make a decision on whether to approve donanemab in 2023.
If approved, donanemab will be available as a monthly injection. The drug will be expensive, but it is likely to be covered by insurance.
Donanemab is not a cure for Alzheimer's disease. However, the drug has the potential to slow the progression of the disease and improve the quality of life for residents with Alzheimer's at The Palace Senior Living Memory Care communities in South Florida and their families.
The approval of donanemab would be a significant advance in the treatment of Alzheimer's disease. The drug would offer hope to people with Alzheimer's and their families, and it would help to change the course of the disease.
LEQEMBI is another Alzheimer's drug developed by Biogen that has recently received full approval from the FDA. It is an anti-beta amyloid drug that is priced to cost $26,500 a year. In a formal phase 3 trial, Leqembi was shown to slow the progression of memory loss and cognitive impairment in patients with early-stage Alzheimer’s disease by about 27 percent over an 18-month period. Lecanemab works by removing a sticky protein from the brain that is believed to cause Alzheimer’s disease to advance.
It's important to note that both drugs are laboratory-made antibodies. In trials, each significantly reduced the brain amyloid levels of Alzheimer’s patients in the early stages of the disease. More important, the patients’ cognitive declines slowed. We are excited to learn about these and other drugs which are in clinical trials. If you have any questions regarding these medications, please contact your physician.
