Treatment with the monoclonal antibody (mAb) gantenerumab (Genentech, South San Francisco, CA; Roche, Basel, Switzerland) was associated with a lower amyloid plaque burden in people with early Alzheimer disease (AD), but it did not slow cognitive decline after 116 weeks. These findings are from the phase 3 GRADUATE I (NCT03444870) and GRADUATE II (NCT03443973) clinical trials which were published in The New England Journal of Medicine.
Gantenerumab is a fully human, anti-Aβ immunoglobulin G1 (IgG1) mAb that is delivered subcutaneously. It has a higher affinity for aggregated Aβ than any mAb previously tested for the treatment of AD. The phase 3 GRADUATE I and GRADUATE II clinical trials included 985 and 980 participants, respectively, aged 50 to 90 years with mild cognitive impairment or mild dementia due to AD and evidence of amyloid plaques based on PET or cerebrospinal fluid (CSF) testing.
In terms of results:
“We are profoundly grateful to the study participants, their care partners and study sites for their contributions to this research,” said Levi Garraway, MD, PhD, Chief Medical Officer and Head of Global Product Development at Genentech. “While the GRADUATE results are not what we hoped, we are proud to have delivered a high quality, clear and comprehensive Alzheimer’s dataset to the field, and we look forward to sharing our learnings with the community as we continue to search for new treatments for this complex disease.”
The findings from the GRADUATE I and GRADUATE II clinical trials highlights the importance of research into the relationship between Aβ and clinical decline in AD.
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