Pilot Study of Serotonin 2A Receptor (5-HT2A) Agonist Psilocybin for Depression in Patients With Mild Cognitive Impairment or Early Alzheimer's Disease

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

Sponsors

Lead sponsor: Johns Hopkins University

Source Johns Hopkins University
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.

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.

Overall Status Recruiting
Start Date June 22, 2020
Completion Date March 8, 2022
Primary Completion Date March 1, 2022
Phase Early Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in Cornell Scale for Depression in Dementia (CSDD) score Baseline and 1 week after second psilocybin session
Secondary Outcome
Measure Time Frame
Change in Quality of Life Alzheimer's Disease (QOL-AD) scale score Baseline and 2 weeks after second psilocybin session
Enrollment 20
Condition
Intervention

Intervention type: Drug

Intervention name: Psilocybin

Description: 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.

Arm group label: Psilocybin

Eligibility

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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Albert Garcia-Romeu, MD Principal Investigator Johns Hopkins University
Overall Contact

Last name: Hillary Jackson

Phone: 4105505466

Email: [email protected]

Location
facility status contact investigator Behavioral Pharmacology Research Unit Hillary Jackson 410-550-5466 [email protected] Albert Garcia-Romeu, PhD Principal Investigator Paul B Rosenberg, MD Principal Investigator
Location Countries

United States

Verification Date

March 2020

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Arm group label: Psilocybin

Arm group type: Experimental

Description: 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.

Patient Data No
Study Design Info

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov