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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I am between 60 and 75 years old.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Synaptic Vesicular Density
Secondary outcome measures
Executive Function
Global Cognition
Memory
Other outcome measures
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%
Suicidal Ideation
4%
Oropharyngeal pain
4%
Insomnia
4%
Influenza
4%
Depression
4%
Diarrhea
4%
Headache
4%
Sinus headache
4%
Depressed mood
4%
Lower resp. tract congestion
4%
Alcohol withdrawal syndrome
2%
Restlessness
2%
Fungal infection
2%
Rhinorrhea
2%
Pyrexia
2%
Oedema
2%
Vomiting
2%
Musculoskeletal pain
2%
Hypoesthesia
2%
Peripheral swelling
2%
Thrombocytosis
2%
Eye infection
2%
Constipation
2%
Dermatitis contact
2%
Bronchitis bacterial
2%
Traumatic lung injury
2%
Hyponatremia
2%
Arthralgia
2%
Pain in extremity
2%
Dizziness
2%
Migraine
2%
Sedation
2%
Anger
2%
Anxiety
2%
Cough
2%
Sexual abuse
2%
Sinus congestion
2%
Malignant melanoma
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
~730

Find a Location

Who is running the clinical trial?

Centre for Addiction and Mental HealthLead Sponsor
356 Previous Clinical Trials
81,398 Total Patients Enrolled
Philip Gerretsen, MD, PhDPrincipal InvestigatorCentre for Addiction and Mental Health
5 Previous Clinical Trials
234 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can elderly individuals be enrolled in the research trial?

"This research study is recruiting participants aged between 60 and 75 years old."

Answered by AI

Has the FDA sanctioned Amnestic Mild Cognitive Impairment Participants Receiving Psilocybin?

"The safety of Amnestic Mild cognitive impairment Participants Receiving Psilocybin has been assigned a rating of two, as the clinical trial is in its second phase. This means there are results showing it to be safe but no studies that conclusively demonstrate efficacy."

Answered by AI

What criteria must be satisfied in order to enroll in this clinical investigation?

"This trial is only open to those with mild cognitive impairment aged between 60 and 75 years old, and the study's capacity sits at a total of 60 participants."

Answered by AI

Is enrollment still available for this research project?

"According to the information posted on clinicaltrials.gov, this medical trial is not currently seeking participants. This research endeavor was first uploaded on September 1st 2023 and its last update was issued on September 14th 2023. Although there are no active recruitment efforts for this particular study, 632 other trials still require patients at the moment."

Answered by AI

Who else is applying?

What site did they apply to?
Centre for Addiction and Mental Health
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Does Psilocybin Change Synaptic Density in Amnestic Mild Cognitive Impairment
Philip Gerretsen 2023. "Does Psilocybin Change Synaptic Density in Amnestic Mild Cognitive Impairment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06041152.
All > Psilocybin > Mild Cognitive Impairment
~40 spots leftby Jul 2026
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