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

• Status: Recruiting
• Trial end date: 2022-09-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Treatments: Psilocybin

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