RecruitingPhase 1NCT07386730

A Study of Psychedelics in Healthy Older Adults With Low Well-being

A Double Blind, Randomized Trial Investigating the Safety, Feasibility, and Mechanisms of Psychedelics in Healthy Older Adults With Low Well-being as Moderated by Biomarkers for Preclinical Alzheimer's Disease


Sponsor

Jennifer Mitchell

Enrollment

80 participants

Start Date

Jun 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This study is being conducted to understand changes in brain activity following administration of two different drugs (Psilocybin and Dextromethorphan) in older adults with low well-being. The main questions it aims to answer are, does psilocybin: 1. Acutely increase complexity of EEG activity in older adults with low well-being, as modulated by the presence of biomarkers of Alzheimer's disease (AD) pathology. 2. Longitudinally decrease plasma markers of neuroinflammation, as modulated by the presence of biomarkers of AD pathology. 3. Explore longitudinal changes in autonomic physiology via wearable recording devices as well as longitudinal structural and functional brain changes measured in the MRI Participants will be in the study for up to 3 months, which will include 3 to 4 in person visits and 3 to 4 remote visits. Most visits will be between 1 to 3 hours, but the dosing visit will last a minimum of 8 hours and could be as long as 12 hours. During the dosing visit, all participants will receive a single dose of the study drugs and dosages listed below. Researchers will compare participants who receive the following drug options: * A low-to-moderate dose of Psilocybin (5-10 mg) * A moderate-to-high dose of Psilocybin (25-30 mg) * A low-to-moderate dose of Dextromethorphan (30-60 mg) * A moderate-to-high dose of Dextromethorphan (80-90 mg)


Eligibility

Min Age: 50 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Dextromethorphan (DXM) and Psilocybin (drug) for people with anhedonia in healthy volunteers and older adults (50-90 years). The study is currently recruiting participants at 1 location.

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 (drug)

Participants will receive either Psilocybin or Dextromethorphan in this clinical trial

DRUGDextromethorphan (DXM)

Participants will receive either Psilocybin or Dextromethorphan in this clinical trial


Locations(1)

University of California San Francisco, Sandler Neuroscience Building

San Francisco, California, United States

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NCT07386730


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