RecruitingEarly Phase 1

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 85 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 6 months

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This small study tests whether psilocybin, a drug that changes how people see and feel things, is safe and helps treat depression when given with support. It is for people with mild memory and thinking problems or early Alzheimer's disease, and it also looks at quality of life.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have mild memory and thinking problems or mild Alzheimer's disease that meet the study's diagnosis rules.
  • Score above 18 on the Mini-Mental State Examination, a memory and thinking test.
  • Score below 26 on the Montreal Cognitive Assessment, another memory and thinking test.
  • Have depression symptoms: a score of at least 6 on the Cornell depression scale or at least 5 on the short Geriatric Depression Scale.
  • If taking an acetylcholinesterase inhibitor, a medicine for memory symptoms, have a steady dose for more than 6 weeks.
  • If taking SSRI or SNRI antidepressants or bupropion, have the same medicine and schedule for at least 2 months before screening. Bupropion must be no more than 300 mg a day.
  • Have a close friend or family member who can share information about you with the study team.

Who can't join

  • Be age 86 or older.
  • Take antipsychotic medicines, MAO inhibitors, or antidepressants other than SSRIs, SNRIs, or bupropion. You must also agree to avoid sildenafil, tadalafil, and similar drugs within 72 hours of each psilocybin dose because of low blood pressure risk.
  • Take long-acting opioid pain medicines unless the last dose is at least 2 hours before psilocybin and the next dose is at least 8 hours after it.
  • Have angina (heart-related chest pain), a serious abnormal heart tracing, a stroke history, a mini-stroke within 6 months, artificial heart valves, or uncontrolled blood pressure above 150 for the top number or 95 for the bottom number.
  • Have a heart rate below 50 beats per minute at screening, unless a heart doctor approves participation.
  • Have a seizure disorder, diabetes that needs insulin, kidney function below the study's limit, or liver enzyme blood tests above twice the upper normal limit.
  • Have a personal or close family history (parent, sibling, or child) of schizophrenia, a psychotic disorder, or bipolar I disorder. Psychotic disorders caused by drugs or a medical condition are exceptions.
  • Have used hallucinogens, drugs that change what you see or feel, in the past year.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 \>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. * Acetylcholinesterase inhibitors are allowed so long as the dose has been stable for \> 6 weeks. * Concurrent pharmacotherapy with selective serotonin reuptake inhibitors (SSRI), serotonin and norepinephrine reuptake inhibitors (SNRI), and/or bupropion is allowed if the type and frequency of the therapy has been stable for at least two months prior to screening. Allowable bupropion doses for participants will be ≤300mg/day. * Have a close friend or family member willing and able to serve the role of community observer / informant for data collection procedures Exclusion Criteria: * 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 * Cardiovascular conditions: angina, a clinically significant ECG abnormality (e.g. atrial fibrillation or heart-rate corrected QT interval (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) * Baseline liver enzyme elevation \>2x the upper limit of normal * 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 * Past-year hallucinogen use.

Study sites (1)

MD