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Does Psilocybin Change Synaptic Density in Amnestic Mild Cognitive Impairment

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This Phase II interventional trial (n=60) aims to investigate whether psilocybin affects synaptic vesicular density (SVD) in individuals with amnestic Mild Cognitive Impairment (aMCI) compared to healthy participants.

Details

Randomised, quadruple-blind, parallel-group Phase II study (n=60; 30 aMCI, 30 healthy controls) comparing two 25 mg oral doses of psilocybin separated by one week versus two placebo doses.

Primary outcome is change in synaptic vesicular density measured with 18F-SynVesT-1 PET before and one week after the last dose; additional PET with [18F]T807 for tau, and cognitive testing at 1, 4, and 12 weeks.

Topics:Neurocognitive Disorders

Registry

Registry linkNCT06041152