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NIA statement on crenezumab trial results: Anti-amyloid drug did not demonstrate a statistically significant clinical benefit in people with inherited form of Alzheimer’s disease

Preliminary results from an NIH-funded clinical trial appear to show that an investigational anti-amyloid drug, crenezumab, did not demonstrate a statistically significant clinical benefit in cognitively healthy people who have a rare genetic mutation that causes early-onset Autosomal Dominant Alzheimer's Disease (ADAD).

We offer our deepest thanks to the people who participated in this important clinical trial for their help in advancing our understanding of the complexities of Alzheimer's and related dementias. We look forward to learning more from the full data, which will provide guidance for further research since every new piece of knowledge brings us closer to effective prevention strategies and treatments.

The trial was supported by the Banner Alzheimer's Institute; Neurosciences Group at the University of Antioquia in Colombia; Roche; and NIA, which provided grant support since the launch in 2012 as part of NIHs work to address the National Plan to Address Alzheimer’s Disease.

For the study, researchers tested an anti-amyloid drug in 252 young cognitively unimpaired participants in Colombia who are members of the world’s largest group of families who carry a rare gene mutation (PSEN1 E280A) making them virtually certain to develop Alzheimer's and tend to become cognitively impaired around age 44. The primary trial measures were for cognition and memory over 5 to 8 years. Participants were randomly assigned to receive crenezumab or a placebo. Crenezumab is an antibody therapy that binds to a key type of amyloid protein that accumulates in the brain in Alzheimer's.

We look forward to the cognitive, clinical, brain imaging and cerebrospinal fluid biomarker data from the study, which will be presented at the 2022 Alzheimer’s Association International Conference on Aug. 2. The implications of these findings may have ramifications on how amyloid, a hallmark of Alzheimer’s, is studied as a prevention and therapeutic target.

Richard J. Hodes, M.D., Director, National Institute on Aging, National Institutes of Health

This research was funded in part by NIH grants RF1AG041705 and R01AG055444. Clinical trial number NCT01998841.

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