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

This study is looking at whether psilocybin, a hallucinogenic drug, can safely and effectively reduce depression in people with Mild Cognitive Impairment (MCI) or early Alzheimer's Disease (AD). Researchers also want to see if it improves their quality of life. You might be able to join if you are between 18 and 85 years old and have been diagnosed with MCI or early AD and have symptoms of depression. The study aims to see if psilocybin can improve depression scores one week after the second treatment session. The current status of this study is unclear, and it plans to enroll up to 20 participants.

Study design
This is an open-label pilot study, meaning everyone knows what treatment they are receiving. It will involve up to 20 participants.
What's involved
You would complete an 8-week course of study treatment, including two psilocybin sessions. There will also be follow-up assessments for up to 6 months after the last psilocybin session.
Compensation
Not stated in the trial record.
Follow-up
Participants will have follow-up assessments for up to 6 months after their final psilocybin session.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04123314

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

Recruiting
EARLY_PHASE1Ages 18–85InterventionalTreatment
Johns Hopkins University
~20 participants
Updated 2026-03-16 on ClinicalTrials.gov
What's tested:Psilocybin

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Cornell Scale for Depression in Dementia (CSDD) score
Measured over Baseline and 1 week after second psilocybin session

Conditions

Depressive Symptoms
Depression
Alzheimer Disease
Mild Cognitive Impairment

Explore related trials

Alzheimer's DiseaseDepressionMild cognitive disorder

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Albert Garcia-Romeu, PhD · PRINCIPAL_INVESTIGATOR · Johns Hopkins University

Who to contact

Ian Geithner, MPS
[email protected]
4105505466
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Must meet either A) Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5) criteria for Mild Neurocognitive Disorder due to AD or Major Neurocognitive Disorder due to AD with Mild severity (including probable), or B) meet criteria for MCI including a subjective memory complaint relative to previous functioning and confirmed by Clinical Dementia Rating (CDR) Memory score at screening of \>0.5
Have Mini-Mental State Examination scores \>18
Have a Montreal Cognitive Assessment score \<26.
Have Cornell Scale for Depression in Dementia (CSDD) patient score \>/= 6, or Geriatric Depression Scale-Short Form score ≥ 5, indicating at minimum a mild to moderate degree of distress.
Acetylcholinesterase inhibitors are allowed so long as the dose has been stable for \> 6 weeks.
Concurrent pharmacotherapy with selective serotonin reuptake inhibitors (SSRI), serotonin and norepinephrine reuptake inhibitors (SNRI), and/or bupropion is allowed if the type and frequency of the therapy has been stable for at least two months prior to screening. Allowable bupropion doses for participants will be ≤300mg/day.
Have a close friend or family member willing and able to serve the role of community observer / informant for data collection procedures

Exclusion

Individuals 86 years of age or older will be excluded.
Currently taking antipsychotics, monoamine oxidase (MAO) inhibitors, or antidepressant medications other than SSRIs, SNRIs, or bupropion. Allowable bupropion doses for participants will be ≤300mg/day.
Long-acting opioid pain medications (e.g. oxycodone sustained release, morphine sustained release - which are usually taken at 12 hour intervals) will be allowed if the last dose occurred at least 2 hours before psilocybin administration and the next dose was not scheduled until at least 8 hours after psilocybin administration.
Participants must agree not to take sildenafil, tadalafil, or similar medications within 72 hours of each psilocybin administration, as these medications may potentiate hypotensive reactions to psilocybin
Cardiovascular conditions: angina, a clinically significant ECG abnormality (e.g. atrial fibrillation or heart-rate corrected QT interval (QTc) \>450msec), Transient Ischemic Attack (TIA) in the last 6 months, stroke, artificial heart valves, or uncontrolled hypertension with resting blood pressure systolic \>150 or diastolic \>95
Minimum acceptable heartrate at screening is 50 bpm unless the individual is cleared for participation by a cardiologist, in accord with the American College of Cardiology's 2018 guidelines for bradycardia
Seizure disorder
Insulin dependent diabetes mellitus
Renal disease (creatinine clearance \< 40 ml/min using the Cockcroft and Gault equation)
Baseline liver enzyme elevation \>2x the upper limit of normal
Current or past history of meeting DSM-5 criteria for Schizophrenia, Psychotic Disorder (unless substance-induced or due to a medical condition), or Bipolar I Disorder
Family (i.e., 1st degree relative) history of Schizophrenia, Psychotic Disorder (unless substance-induced or due to a medical condition), or Bipolar I Disorder
Past-year hallucinogen use.

What this trial measures

  • Change in Cornell Scale for Depression in Dementia (CSDD) scoreBaseline and 1 week after second psilocybin session

    The Cornell Scale for Depression in Dementia (CSDD) is administered via patient and informant interviews to assess the presence and severity of depressive mood and behavioral symptoms during the past week. Has 19 items, each scored from 0 to 2 with higher scores indicating severe symptom.Total score range from 0 to 38.