Does Psilocybin Change Synaptic Density in... — Clinical Trial Details

Participants

Ages

60 – 75

Sexes

Male & Female

BMI

Psychosis History

Excluded

Inclusion Criteria

Inclusion Criteria
The aMCI participant must meet all of the inclusion criteria to be eligible for this clinical trial:
1. Male or female participants of any race or ethnicity
2. Inpatients or outpatients 60 to 75 years of age (on day of randomization)
3. Diagnosis of MCI based on DSM 5 diagnostic criteria of Minor Neurocognitive Disorder
4. Categorization of episodic memory impairment based on scores ≥ 1.0 SD lower on any of the following measures in comparison to normative data i. Logical Memory Test, ii. California Verbal Learning Test, iii. Brief Visual Memory Test
5. Non-smoker/Non-nicotine user
6. Montreal Cognitive Assessment (MoCA) score < 26 and MMSE score >= 24
7. Capable of consenting to participate in the research study
8. On a stable dose of medication for at least 2 months, and unlikely to undergo changes in dose during the study
9. Availability of a study partner who has regular contact with the participant
10. Ability to read and communicate in English (with corrected vision and hearing, if needed)
The Healthy Control participant must meet all of the inclusion criteria to be eligible for this clinical trial:
1. Male or female participants of any race or ethnicity
2. 60 to 75 years of age (on day of randomization)
3. Does not meet SCID-5 criteria for Mild Neurocognitive Disorder, Alzheimer's disease, or other major neurocognitive disorder
4. Non-smoker/Non-nicotine user
5. Capable of consenting to participate in the research study
6. On a stable dose of medication for at least 2 months, and unlikely to undergo changes in dose during the study
7. Availability of a study partner who has regular contact with the participant
8. Ability to read and communicate in English (with corrected vision and hearing, if needed)

Exclusion Criteria

Exclusion Criteria
1. Unwilling or incapable to consent to the study
2. Unstable medical or any concomitant major medical or neurological illness, including contraindication to psilocybin (allergy, recent stroke, uncontrolled hypertension, recent myocardial infarction, cardiac arrhythmia, severe coronary artery disease, moderate to severe renal or hepatic impairment)
3. History of head trauma resulting in loss of consciousness > 30 minutes that required medical attention
4. 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
5. DSM-5 substance dependence (except caffeine) within 12 months of entering the study
6. Anticonvulsant, antidepressant, antipsychotic, mood stabilizer, opioid, or benzodiazepine use
7. Use of serotonergic psychedelic drugs within the past 10 years
8. Positive urine drug screen at the screening visit
9. Having taken a cognitive enhancer (acetylcholinesterase inhibitor or memantine) within the past 6 weeks
10. Acute suicidal or homicidal ideation
11. Receiving treatment with medications such as levetiracetam that blocks SV2a binding, and/or inability to discontinue medications including UGT1A9/1A10 inhibitors, ALDH inhibitors and ADH inhibitors before dosing
12. Exceeding allowed annual radiation exposure levels (20 mSv)
13. Having completed multiple PET scans such that participation would exceed lifetime limit (8 PET scans)
14. Metal implants or pacemaker precluding MRI or other contraindications to MRI (e.g., claustrophobia)
15. Female with childbearing potential, pregnancy or breastfeeding
16. Active gender affirming hormonal treatment
17. Any first-degree relative with a diagnosis of schizophrenia-spectrum disorder, psychotic disorder, or bipolar I or II disorder
18. Allergies to hydroxypropyl methylcellulose

Company

Product

Legal

Does Psilocybin Change Synaptic Density in Amnestic Mild Cognitive Impairment

Detailed Description

Study Protocol

Preparation

Dosing

Locations

Integration

Study Arms & Interventions

aMCI Psilocybin

Interventions

Healthy Psilocybin

Interventions

aMCI Placebo

Interventions

Healthy Placebo

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details

Study Team

Sponsors & Collaborators