Other Clinical Trial - Does Psilocybin Change Synaptic Density in Amnestic

Status Recruiting

Clinical Trial Summary

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: 1. Two 25 mg macrodoses of psilocybin separated by 1 week. 2. 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.

Clinical Trial Description

The proposed study will investigate the effects of on synaptic vesicular density (SVD) levels as measured by the positron emission tomography (PET) radiotracer, 18F-SynVesT-1, and cognition (i.e., global cognition, executive function, and memory domains) in amnestic Mild Cognitive Impairment (aMCI) and healthy participants. Participants will be randomized to receive either two 25mg doses of psilocybin separated by one week, or two placebo doses separated by one week. Brain scans, clinical, and cognitive assessments will be conducted one week before, and one week, four weeks, and 12 weeks post dosing. ;

Study Design

Related Conditions & MeSH terms

Amnestic Mild Cognitive Impairment
Cognitive Dysfunction

Clinical Trial Details

NCT number	NCT06041152
Study type	Interventional
Source	Centre for Addiction and Mental Health
Contact	Philip Gerretsen, MD, PhD
Phone	416-535-8501
Email	philip.gerretsen@camh.ca
Status	Recruiting
Phase	Phase 2
Start date	November 27, 2023
Completion date	July 2026

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Does Psilocybin Change Synaptic Density in Amnestic Mild Cognitive Impairment

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms