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Does Psilocybin Change Synaptic Density in Amnestic Mild Cognitive Impairment

StatusActive, Not Recruiting
PhasePhase 2
Started2023-11-27
View on ClinicalTrials.gov ↗
Record status
This record was last updated February 25, 2026 (before its estimated July 2026 completion). Its status may not reflect the trial's current state.

Amendment history

2026-02-24
notable
Recruiting→Active, Not Recruiting Study Status, Oversight, Study Description, Study Design, Contacts/Locations v5
Trial statusRecruiting→Active, Not Recruiting
Enrollment targetestimated 60→confirmed 10
Study sitesdetails revised at 1 of 1 site
2025-07-23
minor
Study Status, Eligibility v4
Eligibility criteria-60 characters
[...] e levels (20 mSv), as outlined by our PET Centre guidelines Disorders of coagulation or taking anticoagulant medication Having completed multiple PET scans in the past, such that p [...]
2025-06-05
minor
Study Identification, Study Status, Eligibility v3
Eligibility criteria-14 characters
[...] sures in comparison to normative data i. Logical Memory Test (62), ii. California Verbal Learning Test (63), iii. ModifiedBrief Rey-OsterriethVisual ComplexMemory Figure (64).Test Non-smoker/Non-nicotine user Montreal Cognitive Assessment [...] tipsychotic, mood stabilizer, opioid, or benzodiazepine use Lifetime useUse of serotonergic psychedelic drugs within the past 10 years Positive urine drug screen at the screening visit Having ta [...]
2025-03-25
minor
Study Identification, Study Status, Oversight v2
Re-verified, no change to tracked fields
2024-02-07
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-09→confirmed 2023-11-27
Study sitesdetails revised at 1 of 1 site
2023-09-14
minor
Original filing
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.
Trial Details
NCT Number NCT06041152
Lead Sponsor Centre for Addiction and Mental Health
Conditions Amnestic Mild Cognitive Impairment
Enrollment 10 participants
Start Date 2023-11-27
Primary Completion 2026-07 (estimated)
Study Completion 2026-07 (estimated)
Updated on ClinicalTrials.gov 2026-02-25