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Comment regarding the FDA’s draft guidance on developing treatments for early Alzheimer’s disease

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In this comment to the Federal Register, Public Citizen expresses concern about the FDA’s draft guidance for developing drugs for early Alzheimer’s disease because the proposed definition of early Alzheimer’s disease and the reliance on biomarkers as both a diagnostic tool and a measure of benefit. Moreover, the proposed criteria for the duration of clinical trials and the selection of clinical endpoints are concerning.