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Placebo

Psilocybin for Mild Cognitive Impairment

Phase 2
Recruiting
Led By Philip Gerretsen, MD, PhD
Research Sponsored by Centre for Addiction and Mental Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Inpatients or outpatients 60 to 75 years of age (on day of randomization)
Be older than 18 years old
Must not have
DSM-5 diagnosis, with active symptoms in the last three months, of major depression; lifetime diagnosis of bipolar disorder; intellectual disability; Alzheimer's Disease; or a psychotic disorder
Active gender affirming hormonal treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years

Summary

This trial will test if psilocybin can improve cognition by increasing synaptic vesicular density in the brain.

Who is the study for?
This trial is for people aged 60-75 with mild cognitive impairment who can consent to participate, have a study partner, and are non-smokers. They must not have used psychedelic drugs before or be at risk of exceeding radiation exposure from PET scans. Participants cannot join if they're pregnant, breastfeeding, on certain medications like anticoagulants or antidepressants, or have had recent serious health issues like strokes.
What is being tested?
Researchers are testing whether psilocybin (a compound found in magic mushrooms) can increase synaptic vesicular density in the brain compared to a placebo. The study involves two doses of either psilocybin or placebo given one week apart and several PET scans and neuropsychological tests before and after treatment to measure changes.
What are the potential side effects?
Potential side effects of psilocybin may include nausea, headache, increased heart rate, blood pressure changes, psychological distress such as anxiety or paranoia during the experience. Long-term side effects are still being studied but could involve persistent changes in perception.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 60 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with major depression, bipolar disorder, intellectual disability, Alzheimer's, or a psychotic disorder.
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I am currently on hormone therapy for gender affirmation.
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I have a blood clotting disorder or am on blood thinners.
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I am unable or unwilling to agree to participate in the study.
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I do not have severe health issues that would make psilocybin unsafe for me.
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I have had a head injury that made me unconscious for more than 30 minutes and needed medical care.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Synaptic Vesicular Density
Secondary study objectives
Executive Function
Global Cognition
Memory
Other study objectives
Exploratory Cognitive Outcomes
Exploratory Primary

Side effects data

From 2021 Phase 2 trial • 95 Patients • NCT02061293
9%
Nausea
7%
Pain
7%
Viral upper resp. tract infection
7%
Back pain
7%
Bronchitis
4%
Diarrhea
4%
Influenza
4%
Headache
4%
Sinus headache
4%
Depressed mood
4%
Depression
4%
Insomnia
4%
Suicidal Ideation
4%
Lower resp. tract congestion
4%
Oropharyngeal pain
4%
Alcohol withdrawal syndrome
2%
Migraine
2%
Thrombocytosis
2%
Constipation
2%
Vomiting
2%
Oedema
2%
Peripheral swelling
2%
Pyrexia
2%
Dermatitis contact
2%
Bronchitis bacterial
2%
Eye infection
2%
Fungal infection
2%
Traumatic lung injury
2%
Hyponatremia
2%
Arthralgia
2%
Musculoskeletal pain
2%
Pain in extremity
2%
Malignant melanoma
2%
Dizziness
2%
Hypoesthesia
2%
Sedation
2%
Anger
2%
Anxiety
2%
Restlessness
2%
Cough
2%
Rhinorrhea
2%
Sinus congestion
2%
Sexual abuse
2%
Endodontic procedure
2%
Mallory-Weiss Syndrom
2%
Anemia
2%
Influenza like Illness
2%
Gingivitis
2%
Arthoscopic surgery
100%
80%
60%
40%
20%
0%
Study treatment Arm
Diphenhydramine
Psilocybin

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Healthy Participants Receiving PsilocybinExperimental Treatment1 Intervention
Receiving 2 doses of 25mg of psilocybin separated by 1 week.
Group II: Amnestic Mild Cognitive Impairment Participants Receiving PsilocybinExperimental Treatment1 Intervention
Receiving 2 doses of 25mg of psilocybin separated by 1 week.
Group III: Healthy Participants Receiving PlaceboPlacebo Group1 Intervention
Receiving 2 doses of placebo separated by 1 week.
Group IV: Amnestic Mild Cognitive Impairment Participants Receiving PlaceboPlacebo Group1 Intervention
Receiving 2 doses of placebo separated by 1 week.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psilocybin
2021
Completed Phase 2
~750

Find a Location

Who is running the clinical trial?

Centre for Addiction and Mental HealthLead Sponsor
368 Previous Clinical Trials
82,976 Total Patients Enrolled
Philip Gerretsen, MD, PhDPrincipal InvestigatorCentre for Addiction and Mental Health
5 Previous Clinical Trials
234 Total Patients Enrolled
~39 spots leftby Jul 2026
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