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

ConditionsDepressive Symptoms Depression Alzheimer Disease Mild Cognitive Impairment

Trial statusRecruiting

Trial phaseEarly Phase 1

Trial typeInterventional

Biological sexAll

Age18-85

SponsorJohns Hopkins University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 >18

Have a Montreal Cognitive Assessment score <26.

Have Cornell Scale for Depression in Dementia (CSDD) patient score >/= 6, or Geriatric Depression Scale-Short Form score ≥ 5, indicating at minimum a mild to moderate degree of distress.

Disqualifiers

Individuals 86 years of age or older will be excluded.

Currently taking antipsychotics, monoamine oxidase (MAO) inhibitors, or antidepressant medications other than SSRIs, SNRIs, or bupropion. Allowable bupropion doses for participants will be ≤300mg/day.

Long-acting opioid pain medications (e.g. oxycodone sustained release, morphine sustained release - which are usually taken at 12 hour intervals) will be allowed if the last dose occurred at least 2 hours before psilocybin administration and the next dose was not scheduled until at least 8 hours after psilocybin administration.

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

Trial design

Design model

Single group

Treatments tested in this trial

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.

Treatment groups

20 Participants

are divided into 1 treatment group

Group A: PsilocybinExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Change in Cornell Scale for Depression in Dementia (CSDD) score

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.

Time frame

Baseline and 1 week after second psilocybin session

Secondary outcomes

Change in Quality of Life Alzheimer's Disease (QOL-AD) scale score

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.

Time frame

Baseline and 2 weeks after second psilocybin session

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Johns Hopkins University

Lead sponsor

Council On Spiritual Practices

Collaborator

Heffter Research Institute