AMSTERDAM, July 17, 2023 /PRNewswire/ -- Data released today by Eli Lilly from the TRAILBLAZER-ALZ 2 clinical trial of donanemab in early symptomatic Alzheimer's disease demonstrates an important advance in Alzheimer's disease research and treatment .
Full Phase 3 data were reported at the Alzheimer's Association International Conference® (AAIC®) 2023, in Amsterdam, the Netherlands, and online. The data were simultaneously published in the Journal of the American Medical Association.
The results showed that donanemab significantly slowed cognitive and functional decline in people with early symptomatic Alzheimer's disease (either mild cognitive impairment or mild dementia), confirming the company's May 2023 primary data release. At AAIC we learned:
"With this more complete picture, there is additional compelling scientific evidence that complete removal of amyloid beta from the brain is associated with a significant slowing of disease progression in people living with early Alzheimer's," said Maria C. Carrillo, MD, Ph.D., Alzheimer's Association chief scientific officer.
"The results illustrate that starting treatment as early as possible allows for the possibility of greater beneficial effect, but also that there is the potential to slow disease progression even when treatment is started later in disease progression," he said. Cheek. "These benefits are real and significant, giving people more time to participate in daily life, remain independent, and make future health care decisions."
TRAILBLAZER-ALZ 2 participants were assessed over 18 months using scales that measure both cognition and function. A prespecified analysis of participants with low to medium tau based on clinical stage showed greater benefit from donanemab in those at earlier stages of the disease.
As with other anti-amyloid treatments, this treatment has side effects. According to the company, the level and severity of amyloid-related imaging abnormalities, also known as ARIA, were consistent with the Phase 2 TRAILBLAZER-ALZ study. ARIA is usually asymptomatic but can be serious. This risk can be managed with careful observation and monitoring, and with withdrawal of treatment, if warranted. Treatment can often be reintroduced.
Patients living with a life-threatening disease and their families should always talk with their doctors to develop a treatment plan that is right for them, including evaluating the benefits and risks of approved therapies.
The company shared publicly that it has completed its submission to the US Food and Drug Administration (FDA) for traditional approval, with regulatory action expected by the end of the year, as well as submissions to other global regulators are on the move. Based on the positive results of clinical trials, the Alzheimer's Association strongly supports traditional FDA approval and, once approved, we hope that CMS and other private insurers will immediately and fully cover this treatment for people who will benefit.
The Alzheimer's Association remains disappointed that so little progress is being made in improving the representation of all affected communities in Alzheimer's clinical trials, including this one. For example, dementia disproportionately affects African Americans and Hispanic Americans; however, all too often, they are severely underrepresented in treatment studies. It is critical that clinical trials accurately reflect the population they seek to serve. We must do everything we can to reach communities that are underrepresented so that the discoveries that are made benefit everyone.
The clinical trial evidence for donanemab differs from that for the two FDA-approved anti-amyloid treatments for Alzheimer's in that study participants discontinue treatment once they reach a predetermined level of amyloid clearance from the brain. Once below a certain threshold, patients were withdrawn from treatment and added to the placebo group. Half (52%) of study participants who received the drug completed treatment in less than 12 months; 72% completed it at 18 months. This is notable for patients, families, prescribers and payers because patients may not need to receive this treatment continuously for the rest of their lives.
As we reflect on the significance of the positive results announced today, the Alzheimer's Association remains committed to advancing all potential treatment avenues and exploring methods to combine various approaches into combination therapies. There must be access to all approved treatments, as well as quality care and support for all people.
About the Alzheimer's Association International Conference® (AAIC®) The Alzheimer's Association International Conference (AAIC) is the world's largest gathering of researchers from around the world focused on Alzheimer's and other dementias. As part of the Alzheimer's Association research program, the AAIC serves as a catalyst for generating new knowledge about dementia and fostering a vital collegiate research community. AAIC 2023 Homepage: www.alz.org/aaic/ AAIC Newsroom 2023: www.alz.org/aaic/pressroom.asp AAIC 2023 Hashtag:
Alzheimer's AssociationThe Alzheimer's Association leads the way in ending Alzheimer's and all other dementias by accelerating global research, driving risk reduction and early detection, and maximizing quality care and support. Our vision is a world without Alzheimer's and all other dementias. Visit alz.org or call the 24/7 helpline at 800.272.3900.
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