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# Questions on Alzheimer’s Drug Draft Guidance
- URL: https://www.fdaweb.com/questions-on-alzheimers-drug-draft-guidance/
- Published: 2024-06-05T12:00:00.000Z
- Updated: 2026-09-14T14:32:35.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157115

The Critical Path Institute (C-Path) says revisions in an FDA draft guidance on developing drugs to treat early Alzheimer’s disease from a 2018 draft “add helpful clarity about strategies to assist sponsors developing treatments for early-stage disease.” The comment [letter](https://www.regulations.gov/comment/FDA-2013-D-0077-0086?ref=fdaweb.com) says this is particularly true in terms of using surrogate endpoints. C-Path also submits line-by-line technical points for FDA to consider.

In its [letter](https://www.regulations.gov/comment/FDA-2013-D-0077-0085?ref=fdaweb.com), Eisai provides comments and questions on diagnosis criteria for early Alzheimer’s, outcome measures — time-to-event analysis, and outcome measures — considerations for stage 3 early Alzheimer’s.