Recruiting

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

Study Aim

This early phase 1 study aims to evaluate the effect of Psilocybin treatment on depression in individuals with mild cognitive impairment or early Alzheimer's disease, measured by changes in the Cornell Scale for Depression in Dementia (CSDD) score.

What is being tested

Psilocybin

Drug

Who is being recruted

Alzheimer Disease+11

+ Behavior

+ Mental Disorders

From 18 to 85 Years

+20 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Early Phase 1

Interventional

Study Start: March 2021

See protocol details

Summary

Principal SponsorJohns Hopkins University

Study ContactIan Geithner, MPSMore contacts

Last updated: March 17, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: March 24, 2021

Actual date on which the first participant was enrolled.

This study explores the potential of psilocybin, a serotonin 2A receptor (5-HT2A) agonist, to improve depression in individuals with Mild Cognitive Impairment (MCI) or early Alzheimer's Disease (AD). The research aims to help those who have significant symptoms of depression along with their diagnosis. The importance of this study lies in its potential to uncover new treatment options for depression in these patients, which could enhance their quality of life and address a currently unmet need in their care. The study involves an open-label trial with up to 20 participants who will undergo an 8-week treatment course. This includes two psilocybin sessions, one in week 4 and another in week 6, with varying doses. Participants' progress will be tracked through follow-up assessments up to 6 months after the final psilocybin session. The main outcome measured is the change in depressed mood one week after the second psilocybin session compared to before the treatment started. This change is evaluated using the Cornell Scale for Depression in Dementia (CSDD), which assesses the severity of depressive symptoms over the past week.

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

NCT04123314

Principal SponsorJohns Hopkins University

Study ContactIan Geithner, MPSMore contacts

Last updated: March 17, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

20 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 85 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Alzheimer DiseaseBehaviorMental DisordersBehavioral SymptomsBrain DiseasesCentral Nervous System DiseasesCognition DisordersDementiaDepressionNervous System DiseasesNeurodegenerative DiseasesNeurocognitive DisordersTauopathiesCognitive Dysfunction

Criteria

7 inclusion criteria required to participate

Have a close friend or family member willing and able to serve the role of community observer / informant for data collection procedures

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

Show More Criteria

13 exclusion criteria prevent from participating

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

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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Participants will complete an 8-week course of study treatment including weekly psychological support and two moderate to high dose psilocybin administrations in weeks 4 and 6.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Johns Hopkins Center for Psychedelic and Consciousness Research

Baltimore, United StatesOpen Johns Hopkins Center for Psychedelic and Consciousness Research in Google Maps

Recruiting

One Study Center