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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04123314
Recruitment Status : Recruiting
First Posted : October 10, 2019
Last Update Posted : March 16, 2023
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Depressive Symptoms Depression Alzheimer Disease Mild Cognitive Impairment Drug: Psilocybin Early Phase 1

Detailed Description:
This is a pilot study evaluating the potential efficacy of psilocybin to produce improvement in depression compared to pre-treatment in people with Mild Cognitive Impairment (MCI) or early Alzheimer's Disease (AD) and clinically significant symptoms of depression. The study will be an open-label trial in a sample of up to 20 treatment-seeking participants with a diagnosis of MCI or early AD. Participants will complete an 8-week course of study treatment including two psilocybin sessions (15 mg/70 kg in week 4 and 15 or 25 mg/70 kg in week 6), with follow-up assessments up to 6 months after the final psilocybin session. The study will assess changes in depressed mood at 1 week after the second psilocybin session compared to pre-treatment, and quality of life in participants from pre- to post-treatment.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of Serotonin 2A Receptor (5-HT2A) Agonist Psilocybin for Depression in Patients With Mild Cognitive Impairment or Early Alzheimer's Disease
Actual Study Start Date : March 24, 2021
Estimated Primary Completion Date : December 30, 2024
Estimated Study Completion Date : December 30, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: Psilocybin
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.


Outcome Measures
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Primary Outcome Measures :
  1. Change in Cornell Scale for Depression in Dementia (CSDD) score [ Time Frame: Baseline 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.


Secondary Outcome Measures :
  1. Change in Quality of Life Alzheimer's Disease (QOL-AD) scale score [ Time Frame: Baseline and 2 weeks after second psilocybin session ]
    The Quality of Life Alzheimer's Disease (QOL-AD) scale is a 13-item measure administered via patient and informant interviews to assess overall mood, physical and cognitive function, and quality of relationships in people with Alzheimer's Disease. Each item is scored 1 to 4, with higher score indicating better quality of life. Total score range from 13 to 52.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 from 18 to 26 (inclusive)
  • Have Cornell Scale for Depression in Dementia (CSDD) patient score > 6, indicating at minimum a mild to moderate degree of distress; or 2) a DSM-5 diagnosis of Major Depressive Disorder, Persistent Depressive Disorder, Mood Disorder due to a Medical Condition, or Adjustment Disorder with depressed mood or with mixed anxiety and depressed mood
  • Have a close friend or family member willing and able to serve the role of community observer / informant for data collection procedures

Exclusion Criteria:

  • Currently taking antidepressants of any drug class, antipsychotics, or Monoamine Oxidase (MAO) inhibitors
  • 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 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)
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04123314


Contacts
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Contact: Hillary Jackson 4105505466 hjacks18@jhmi.edu

Locations
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United States, Maryland
Behavioral Pharmacology Research Unit Recruiting
Baltimore, Maryland, United States, 21224
Contact: Hillary Jackson    410-550-5466    hjacks18@jhmi.edu   
Principal Investigator: Albert Garcia-Romeu, PhD         
Principal Investigator: Paul B Rosenberg, MD         
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Albert Garcia-Romeu, MD Johns Hopkins University
More Information
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Additional Information:

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT04123314    
Other Study ID Numbers: IRB00175915
First Posted: October 10, 2019    Key Record Dates
Last Update Posted: March 16, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johns Hopkins University:
Psilocybin
Hallucinogen
Psychedelic
Additional relevant MeSH terms:
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Alzheimer Disease
Depression
Depressive Disorder
Cognitive Dysfunction
Behavioral Symptoms
Mood Disorders
Mental Disorders
Dementia
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Cognition Disorders
Psilocybin
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs