Usona NIMH25008893
Summary
AI-generated · Aug 24, 2025 procure the primary investigational product psilocybin for an NIH/NIA-sponsored study evaluating psilocybin-assisted cognitive training in healthy older adults and individuals with Alzheimer's disease. Psilocybin is a Schedule I compound and must be sourced from a limited number of qualified manufacturers under GMP conditions for human research.
Usona Institute is the only U.S.-based nonprofit with DEA licensure, GMP manufacturing capacity, IND-enabling material suitable for NIH-sponsored human trials, and an existing IND, and will allow NIA to cross-reference its IND in FDA submissions. This purchase supports the primary investigational product required to fulfill the study’s scientific aims.
This study is an NIH/NIA sponsored investigation examining the potential of psilocybin-assisted cognitive training in healthy older adults and individuals with Alzheimer s disease. Psilocybin is a Schedule I compound that can only be sourced from a limited number of qualified manufacturers authorized to produce it under GMP conditions for human research. Usona Institute is the only U.S.-based non-profit organization with Drug Enforcement Administration (DEA) licensure, GMP manufacturing capacity, IND-enabling material suitable for NIH-sponsored human trials, and holder of an existing IND, who agrees to allow the NIA to cross-reference it in our own application to the FDA. This purchase supports the primary investigational product required to fulfill the scientific aims of the clinical study.
From Special Notice posted on Jul 25, 2025Notice history
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Award Information
Not yet awarded
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Agency
Place of Performance
USA