Alzheimer Disease / Depressive Symptoms / Depression · Phase EARLY_PHASE1 Trial

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

ClinicalTrials.gov · September 4, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a registered clinical trial protocol, not a published result. It is a small, open-label early-phase pilot designed to explore safety and preliminary efficacy of psilocybin for depression in people with mild cognitive impairment or early Alzheimer's disease. No outcome data are available in this registry record.

What was studied

Early Phase 1, Interventional, Single Group, Open label, Treatment purpose. Depressive Symptoms, Depression, Alzheimer Disease, Mild Cognitive Impairment; age from 18 Years; to 85 Years. Intervention: Psilocybin. n = 20. 1 site: United States.

Key findings

Safety

Very small sample size (n=20 estimated); insufficient for robust safety or efficacy conclusions.

Who this may help

This protocol describes an exploratory study in a population (cognitively impaired older adults) rarely studied with psychedelics. Results, when available, should be interpreted as hypothesis-generating only; no practice recommendations can be drawn from a registry record alone.

Plain-language summary

Early-phase pilot study with no results yet reported; designed to assess safety and feasibility of psilocybin in a cognitively vulnerable population.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Change in Cornell Scale for Depression in Dementia (CSDD) score (assessed at Baseline and 1 week after second psilocybin session)

DesignEarly Phase 1, Interventional, Single Group, Open label, Treatment purpose

PopulationDepressive Symptoms, Depression, Alzheimer Disease, Mild Cognitive Impairment; age from 18 Years; to 85 Years

Sample size20

InterventionPsilocybin

Setting1 site: United States

Reported figures

Quoted from the source exactly as published.

Estimated enrollment20

PhaseEARLY_PHASE1

Primary outcome measureChange in Cornell Scale for Depression in Dementia (CSDD) score, baseline and 1 week after second psilocybin session

Clinical bottom line

Caveats

No results are posted in this registry record; study status is recruiting.
Open-label design limits causal inference; lack of blinded comparator.
Very small sample size (n=20 estimated); insufficient for robust safety or efficacy conclusions.
Study does not report whether secondary outcomes or follow-up duration beyond 1 week post-intervention are planned.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

limited

Open-label design with no comparator arm; vulnerable to bias.

Directness

strong

Primary outcome directly measures depression in target population.

Consistency

insufficient

Single study; no comparative data reported in this registry record.

Risk of bias

limited

Open-label design without blinding; no control group to mitigate detection bias.

Sample adequacy

limited

Very small estimated enrollment of 20 participants in early-phase pilot.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT04123314). This is a study registration, not published results. Lead sponsor: Johns Hopkins University. Recruitment status: RECRUITING. Phase: EARLY_PHASE1. Study type: INTERVENTIONAL. Enrollment: 20 participants (ESTIMATED). Conditions: Depressive Symptoms, Depression, Alzheimer Disease, Mild Cognitive Impairment. Interventions: DRUG: Psilocybin. Primary outcome measures: Change in Cornell Scale for Depression in Dementia (CSDD) score , Baseline and 1 week after second psilocybin session. 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Alzheimer DiseaseDepressive SymptomsNCT04123314DepressionPsilocybinJohns Hopkins University