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

Psilocybin

Brief 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.

Intervention / Treatment

  • Drug: Psilocybin

Condition or Disease

  • Depressive Symptoms
  • Depression
  • Alzheimer Disease
  • Mild Cognitive Impairment

Phase

Study Design

Study type: Interventional
Status: Recruiting
Study results: No Results Available
Age: 18 Years to 85 Years   (Adult, Older Adult)
Enrollment: 20 ()
Funded by: Other

Masking

Clinical Trial Dates

Start date: Mar 24, 2021
Primary Completion: Dec 30, 2023
Completion Date: Dec 30, 2023
Study First Posted: Oct 10, 2019
Results First Posted: Aug 30, 2020
Last Updated: Mar 24, 2022

Sponsors / Collaborators

Lead Sponsor: N/A
Responsible Party: N/A

Location

Baltimore, Maryland, USA

This is a pilot study evaluating the potential efficacy of psilocybin to produce improvement in depression compared to pre-treatment in people with Mild Cognitive Impairment (MCI) or early Alzheimer's Disease (AD) and clinically significant symptoms of depression. The study will be an open-label trial in a sample of up to 20 treatment-seeking participants with a diagnosis of MCI or early AD. Participants will complete an 8-week course of study treatment including two psilocybin sessions (15 mg/70 kg in week 4 and 15 or 25 mg/70 kg in week 6), with follow-up assessments up to 6 months after the final psilocybin session. The study will assess changes in depressed mood at 1 week after the second psilocybin session compared to pre-treatment, and quality of life in participants from pre- to post-treatment.

Eligibility Criteria

Sex: All
Minimum Age: 18

This clinical trial is recruiting

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More Details

NCT Number: NCT04123314
Other IDs: IRB00175915
Study URL: https://ClinicalTrials.gov/show/NCT04123314
Last updated: Jun 16, 2022