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Does Psilocybin Change Synaptic Density in Amnestic Mild Cognitive Impairment

NCT06041152 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-02-25

No results posted yet for this study

Summary

The goal of this pilot, exploratory, 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.

10 participants (6 with aMCI, and 4 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.
* Depending on available funds, 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.

Conditions

  • Amnestic Mild Cognitive Impairment

Interventions

DRUG

Psilocybin

2 macrodoses of 25mg separated by one week.

DRUG

Placebo

2 doses of placebo separated by one week.

Sponsors & Collaborators

  • Centre for Addiction and Mental Health

    lead OTHER

Principal Investigators

  • Philip Gerretsen, MD, PhD · Centre for Addiction and Mental Health

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-27
Primary Completion
2026-07-31
Completion
2026-07-31

Countries

  • Canada

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06041152 on ClinicalTrials.gov