Actively Recruiting

Early Phase 1
Age: 18Years - 85Years
All Genders
NCT04123314

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

Led by Johns Hopkins University · Updated on 2026-03-16

20

Participants Needed

1

Research Sites

301 weeks

Total Duration

On this page

Sponsors

J

Johns Hopkins University

Lead Sponsor

C

Council On Spiritual Practices

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Meet DSM-5 criteria for Mild Neurocognitive Disorder due to AD or Major Neurocognitive Disorder due to AD with mild severity, or meet criteria for MCI including a subjective memory complaint confirmed by Clinical Dementia Rating Memory score >0.5
  • Mini-Mental State Examination score greater than 18
  • Montreal Cognitive Assessment score less than 26
  • Cornell Scale for Depression in Dementia patient score 6 or higher, or Geriatric Depression Scale-Short Form score 5 or higher
  • Stable dose of acetylcholinesterase inhibitors for more than 6 weeks
  • Stable pharmacotherapy with SSRIs, SNRIs, and/or bupropion (dose ≤300mg/day) for at least 2 months prior to screening
  • Have a close friend or family member willing and able to serve as a community observer/informant for data collection
Not Eligible

You will not qualify if you...

  • Age 86 years or older
  • Currently taking antipsychotics, monoamine oxidase inhibitors, or antidepressants other than SSRIs, SNRIs, or bupropion
  • Taking long-acting opioid pain medications without appropriate timing around psilocybin administration
  • Use of sildenafil, tadalafil, or similar medications within 72 hours of psilocybin administration
  • Cardiovascular conditions including angina, significant ECG abnormalities, recent Transient Ischemic Attack, stroke, artificial heart valves, or uncontrolled hypertension (systolic >150 or diastolic >95)
  • Heart rate below 50 bpm unless cleared by a cardiologist
  • Seizure disorder
  • Insulin dependent diabetes mellitus
  • Renal disease with creatinine clearance less than 40 ml/min
  • Baseline liver enzyme elevation greater than twice the upper limit of normal
  • Current or past diagnosis of Schizophrenia, Psychotic Disorder (except substance-induced or due to medical condition), or Bipolar I Disorder
  • Family history of Schizophrenia, Psychotic Disorder, or Bipolar I Disorder
  • Hallucinogen use in the past year

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Johns Hopkins Center for Psychedelic and Consciousness Research

Baltimore, Maryland, United States, 21224

Actively Recruiting

Loading map...

Research Team

I

Ian Geithner, MPS

CONTACT

A

Albert Garcia-Romeu, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here