Article
The science does not yet support regulatory approval of amyloid‐targeting therapies for Alzheimer's disease based solely on biomarker evidence
1 Apr 2025
Abstract excerpt
Amyloid load reduction is an unvalidated surrogate for clinical benefit. Amyloid-targeting antibodies have demonstrated efficacy in both amyloid reduction and slowing cognitive decline due to AD at the mild cognitive impairment (MCI) and mild dementia stages. However, no individual-level mediation analysis has been released to demonstrate that the clinical efficacy of amyloid-targeting antibodies is associated...
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