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Hallucinogen

Psilocybin for Depression in Alzheimer's

Verified Trial
Phase < 1
Recruiting
Led By Albert Garcia-Romeu, MD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have you been diagnosed with Alzheimer’s Disease, early Alzheimer’s Disease, or Mild Cognitive Impairment? Mild Cognitive Impairment is a condition in which people experience memory problems beyond association with normal aging, but these symptoms are not as severe as those associated with Alzheimer’s Disease.
This study typically involves two in-person screening meetings in Baltimore, MD as well as 1-2 treatment meetings per week for 8 weeks. Most of the treatment meetings will be about 8-10 hours in length. Treatment will be followed by 3 follow-up meetings at 1, 3, and 6 months after treatment. If you meet the criteria for the study, could you make this time commitment?
Timeline
Screening 2 days
Treatment Varies
Follow Up 1 day
Awards & highlights
No Placebo-Only Group

Summary

This trial tests if psilocybin, a substance from certain mushrooms, can safely improve depression and quality of life in people with early Alzheimer's or Mild Cognitive Impairment. It works by changing brain activity related to mood. Psilocybin has been studied for its potential to reduce depression and anxiety, particularly in patients with life-threatening conditions.

Who is the study for?
This trial is for people with mild cognitive impairment or early Alzheimer's who are currently depressed. Participants must be able to commit to several long treatment sessions in Baltimore, MD, and have a close friend or family member involved in the study. Exclusions include severe mental health conditions, certain cardiovascular issues, insulin-dependent diabetes, and those on specific medications.
What is being tested?
The trial is testing psilocybin's safety and effectiveness for treating depression in individuals with mild cognitive impairment or early Alzheimer's Disease. It aims to see if it can also improve their quality of life.
What are the potential side effects?
While not explicitly listed here, potential side effects of psilocybin may include nausea, headache, increased heart rate, blood pressure changes, and psychological effects such as anxiety or hallucinations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with Alzheimer's or Mild Cognitive Impairment.
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I can attend long treatment sessions in Baltimore and follow-up meetings.
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I am currently experiencing a depressive episode.
Select...
I have been diagnosed with Alzheimer's or Mild Cognitive Impairment.
Select...
I have someone close who can discuss changes in my mood and behavior for the study.

Timeline

Screening ~ 2 days
Treatment ~ Varies
Follow Up ~1 day
This trial's timeline: 2 days for screening, Varies for treatment, and 1 day for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Cornell Scale for Depression in Dementia (CSDD) score
Secondary study objectives
Change in Quality of Life Alzheimer's Disease (QOL-AD) scale score

Side effects data

From 2021 Phase 2 trial • 95 Patients • NCT02061293
9%
Nausea
7%
Pain
7%
Viral upper resp. tract infection
7%
Back pain
7%
Bronchitis
4%
Diarrhea
4%
Influenza
4%
Headache
4%
Sinus headache
4%
Depressed mood
4%
Depression
4%
Insomnia
4%
Suicidal Ideation
4%
Lower resp. tract congestion
4%
Oropharyngeal pain
4%
Alcohol withdrawal syndrome
2%
Migraine
2%
Thrombocytosis
2%
Constipation
2%
Vomiting
2%
Oedema
2%
Peripheral swelling
2%
Pyrexia
2%
Dermatitis contact
2%
Bronchitis bacterial
2%
Eye infection
2%
Fungal infection
2%
Traumatic lung injury
2%
Hyponatremia
2%
Arthralgia
2%
Musculoskeletal pain
2%
Pain in extremity
2%
Malignant melanoma
2%
Dizziness
2%
Hypoesthesia
2%
Sedation
2%
Anger
2%
Anxiety
2%
Restlessness
2%
Cough
2%
Rhinorrhea
2%
Sinus congestion
2%
Sexual abuse
2%
Endodontic procedure
2%
Mallory-Weiss Syndrom
2%
Anemia
2%
Influenza like Illness
2%
Gingivitis
2%
Arthoscopic surgery
100%
80%
60%
40%
20%
0%
Study treatment Arm
Diphenhydramine
Psilocybin

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: PsilocybinExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psilocybin
2021
Completed Phase 2
~530

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,323 Previous Clinical Trials
14,874,280 Total Patients Enrolled
57 Trials studying Depression
29,522 Patients Enrolled for Depression
Albert Garcia-Romeu, MDPrincipal InvestigatorJohns Hopkins University

Media Library

Psilocybin (Hallucinogen) Clinical Trial Eligibility Overview. Trial Name: NCT04123314 — Phase < 1
Depression Research Study Groups: Psilocybin
Depression Clinical Trial 2023: Psilocybin Highlights & Side Effects. Trial Name: NCT04123314 — Phase < 1
Psilocybin (Hallucinogen) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04123314 — Phase < 1
Depression Patient Testimony for trial: Trial Name: NCT04123314 — Phase < 1
~0 spots leftby Dec 2024