Does Psilocybin Change Synaptic Density in Amnestic Mild Cognitive Impairment

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.

Conducted by the Centre for Addiction and Mental Health, Canada, the study hypothesizes that psilocybin ingestion will lead to higher SVD levels in the brain, potentially associated with cognitive improvements.

Participants, aged 60 to 75, will be randomised to receive either two 25 mg doses of psilocybin or placebo separated by one week. Primary outcomes include measuring SVD using PET imaging and assessing cognition, while secondary outcomes involve examining memory and executive function. The study spans from November 2023 to July 2026, with contact details provided for study inquiries.

Topic Neurocognitive Disorders
Compound Placebo Psilocybin
Country Canada
Visit trial
Status Recruiting
Results Published No
Start date 27 November 2023
End date 31 July 2026
Phase Phase II
Design Blinded
Type Interventional
Generation First
Participants 59
Sex All
Age 60- 75
Therapy No

Trial Details

The goal of this clinical trial is to investigate the effects of psilocybin on synaptic vesicular density (SVD) as measured by the positron emission tomography (PET) radiotracer, 18F-SynVesT-1, in participants with amnestic Mild Cognitive Impairment (aMCI) and healthy participants. The investigators hypothesize that SVD levels in the brain will be higher following the ingestion of psilocybin in comparison to placebo, and that increases in SVD will be associated with improvements in cognition. 60 participants (30 with aMCI, and 30 sex and age matched healthy volunteers) will: Be randomized to receive either: Two 25 mg macrodoses of psilocybin separated by 1 week. Two placebo doses separated by 1 week. Receive a baseline 18F-SynVesT-1 PET scan, clinical, and neuropsychological assessments. Receive a 18F-SynVesT-1 PET scan one week after the last dose of treatment. Receive a third PET scan at any time within 4 weeks of the screening visit to quantify tauopathy with the [18F]T807 radiotracer. Receive clinical and neuropsychological testing 1, 4, and 12 weeks after the last treatment. Researchers will compare placebo vs. experimental groups to see if psilocybin will increase SVD, and if increases in SVD are associated with cognitive improvements.

NCT Number NCT06041152

Data attribution

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