A paper announcing the results of two large phase 3 trials evaluating the effects of the drug “gantenerumab” in people with early Alzheimer's disease was published on November 16, 2023, in the New England Journal of Medicine. The GRADUATE I and GRADUATE II trials found that while gantenerumab led to reduced amyloid plaque levels in the brain compared to placebo, it did not significantly slow clinical decline over the 116-week study period.
The studies were conducted, in part, at the Memory and Aging Program (MAP) at Butler Hospital. Dr. Stephen Salloway, MD, MS, MAP founder and Professor of Neurology and Psychiatry at the Alpert Medical School of Brown University, served as the Project Arm Leader for the studies and is a co-author of the paper.
“While the clinical results were disappointing, the trials add to our understanding of the complex relationship between removing amyloid and slowing disease progression,” said Dr. Salloway. “They also have provided valuable data to inform future Alzheimer's drug development.”
The two randomized, placebo-controlled trials named GRADUATE I and II enrolled a total of 1,965 participants with early Alzheimer's at sites around the world. Participants had mild cognitive impairment or mild dementia due to Alzheimer's. They were randomly assigned to receive injections of gantenerumab or a placebo every two weeks for 116 weeks.
The primary outcome was a change from baseline on the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB), which measures cognitive and functional impairment. On this measure, gantenerumab was not found to be significantly different from the placebo in either trial. However, PET brain imaging revealed that gantenerumab led to a substantially lowered amyloid plaque burden compared to placebo after 116 weeks.
The full results are published in the November 16, 2023, issue of the New England Journal of Medicine.
How to Get Involved in Alzheimer’s Research
Effective treatment and even prevention of Alzheimer's is closer than ever before, and now you can help by joining the Alzheimer’s Prevention Registry. The registry allows us to match people interested in participating in research, with studies for which they may qualify.
Learn more about the Alzheimer’s Prevention Registry by visiting: https://www.butler.org/memory/registry.
Disclaimer: The content in this blog is for informational and educational purposes only and should not serve as medical advice, consultation, or diagnosis. If you have a medical concern, please consult your healthcare provider, or seek immediate medical treatment.
