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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT04123314
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Psilocybin — DRUG
    Dosing at the first session will be 15 mg/70 kg. For the second session participants will either remain at the initial dose, or increase to 25 mg/70 kg at the discretion of the study team.

Study Details

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.

Key Dates

Start date
Mar 24, 2021
Status verified
Mar 2026
Primary completion
Sep 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Psilocybin
    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.

Primary Outcome Measure

Change in Cornell Scale for Depression in Dementia (CSDD) score [ Time Frame: Baseline and 1 week after second psilocybin session ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins Center for Psychedelic and Consciousness ResearchBaltimoreMaryland21224
Ian Geithner, MPS
[email protected]
410-550-5466
Albert Garcia-Romeu, PhD
[email protected]
410-550-1972
Albert Garcia-Romeu, PhD (PRINCIPAL_INVESTIGATOR)
Paul B Rosenberg, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Baltimore, MD

By condition
Alzheimer's diseaseDepression
By specialty
NeurologyDementia careBrain disordersGeriatricsPsychiatryMental healthBehavioral health
By research site
Johns Hopkins Center for Psychedelic and Consciousness Research· Baltimore, MD

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