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# Alzheimer’s Drug Development Draft Guidance
- URL: https://www.fdaweb.com/alzheimers-drug-development-draft-guidance/
- Published: 2024-03-12T12:00:00.000Z
- Updated: 2026-09-14T14:25:03.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5156535

*Federal Register* notice: FDA is making available a draft guidance entitled “Early Alzheimer’s Disease: Developing Drugs for Treatment.” The document addresses drug clinical development for treating stages of sporadic Alzheimer’s disease that occur before the onset of overt dementia. It discusses the use of biomarkers reflecting underlying AD pathophysiological changes and the enrollment of subjects with AD at earlier stages of the disease. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2024-03-12/pdf/2024-05178.pdf?ref=fdaweb.com).