Phase 3 clinical trial results reported in July 2023 showed that the drug donanemab significantly slowed cognitive and functional decline in people living with early symptomatic Alzheimer's disease (either mild cognitive impairment or mild dementia).
By slowing progression of the disease when taken in the early stages of Alzheimer's, donanemab, if approved by the U.S. Food and Drug Administration (FDA), will allow people to have more time to participate in daily life and live independently. Individuals should talk with their health care provider to develop an Alzheimer's treatment plan that is right for them, including weighing the benefits and risks of all approved medications and therapies.
Fore more information about donanemab, see below. Contact the Alzheimer’s Association 24/7 Helpline at 800.272.3900 for support or with additional questions.
Is donanemab FDA-approved?
No. Lilly submitted its traditional approval application of donanemab to the FDA and expects action by early 2024.
Is donanemab a cure for Alzheimer's and all other dementia?
No. Donanemab is not a cure, but it has been shown to slow disease progression in clinical trials.
How to navigate treatment options
There is exciting progress in Alzheimer’s and dementia research that is creating promising new treatments. It is important to learn as much as you can about which drugs are available.
We will continue our efforts to discover new targets and test new and more effective treatments for Alzheimer's and all other dementia.
The Alzheimer's Association remains committed to advancing all potential treatment avenues and exploring methods for combining diverse approaches into combination therapies.
Will this drug restore memories or cognitive function that has been lost?
There is no evidence to date that this or any treatment can restore or reverse memory loss or cognitive function due to Alzheimer's disease.
In the study results, the treatment effect continued to increase relative to placebo over the course of the trial, with the largest differences versus placebo seen at 18 months.
Study participants at the earliest stage of disease had greater benefit, with 60% slowing of decline compared to placebo. Significant benefits were also seen in more advanced patients.
Nearly half (47%) of study participants at the earliest stage of disease who received donanemab had no clinical progression at one year.
How do I receive this treatment?
This treatment is not yet FDA-approved and is only available by participating in enrolling donanemab clinical trials.
How does donanemab compare to other monoclonal antibodies?
While monoclonal antibodies like donanemab, lecanemab and aducanumab that target beta-amyloid in the brain belong to the same class of treatments, no treatments are the same. They work differently by targeting beta-amyloid at different stages of plaque formation, and ultimately these treatments lower beta-amyloid to slow progression of the disease and to reduce clinical decline.