RecruitingEarly Phase 1NCT04123314

Psilocybin for Depression in People With Mild Cognitive Impairment or Early Alzheimer's Disease

Pilot Study of Serotonin 2A Receptor (5-HT2A) Agonist Psilocybin for Depression in Patients With Mild Cognitive Impairment or Early Alzheimer's Disease


Sponsor

Johns Hopkins University

Enrollment

20 participants

Start Date

Mar 24, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

This open-label pilot study examines whether the hallucinogenic drug, psilocybin, given under supportive conditions, is safe and effective for depression in people with Mild Cognitive Impairment (MCI) or early Alzheimer's Disease (AD). This study will also assess whether psilocybin may improve quality of life in those individuals.


Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether psilocybin (the active compound in 'magic mushrooms,' given in a controlled medical setting) can safely reduce depression in people with mild cognitive impairment or early Alzheimer's disease. It is one of the first trials to explore this in people with dementia-related conditions. **You may be eligible if...** - You have been diagnosed with mild cognitive impairment or early/mild Alzheimer's disease - You have a cognitive test score (MMSE) above 18 and MoCA score below 26 - You show at least mild depressive symptoms on a standard scale - If you take antidepressants (SSRIs, SNRIs, or bupropion up to 300 mg/day), the dose has been stable for at least 2 months - You have a close friend or family member who can act as a study observer **You may NOT be eligible if...** - You are 86 years old or older - You are currently taking antipsychotics, MAO inhibitors, or antidepressants other than SSRIs, SNRIs, or bupropion - You have a history of serious psychiatric conditions (such as schizophrenia or bipolar disorder with psychosis) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPsilocybin

Dosing at the first session will be 15 mg/70 kg. For the second session participants will either remain at the initial dose, or increase to 25 mg/70 kg at the discretion of the study team.


Locations(1)

Johns Hopkins Center for Psychedelic and Consciousness Research

Baltimore, Maryland, United States

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NCT04123314


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