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Hallucinogen
Psilocybin for Depression in Alzheimer's
Verified Trial
Phase < 1
Recruiting
Led By Albert Garcia-Romeu, MD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have you been diagnosed with Alzheimer’s Disease, early Alzheimer’s Disease, or Mild Cognitive Impairment? Mild Cognitive Impairment is a condition in which people experience memory problems beyond association with normal aging, but these symptoms are not as severe as those associated with Alzheimer’s Disease.
This study typically involves two in-person screening meetings in Baltimore, MD as well as 1-2 treatment meetings per week for 8 weeks. Most of the treatment meetings will be about 8-10 hours in length. Treatment will be followed by 3 follow-up meetings at 1, 3, and 6 months after treatment. If you meet the criteria for the study, could you make this time commitment?
Timeline
Screening 2 days
Treatment Varies
Follow Up 1 day
Awards & highlights
Study Summary
This trial will test whether the hallucinogenic drug psilocybin is safe and effective for treating depression in people with Mild Cognitive Impairment or early Alzheimer's Disease.
Who is the study for?
This trial is for people with mild cognitive impairment or early Alzheimer's who are currently depressed. Participants must be able to commit to several long treatment sessions in Baltimore, MD, and have a close friend or family member involved in the study. Exclusions include severe mental health conditions, certain cardiovascular issues, insulin-dependent diabetes, and those on specific medications.Check my eligibility
What is being tested?
The trial is testing psilocybin's safety and effectiveness for treating depression in individuals with mild cognitive impairment or early Alzheimer's Disease. It aims to see if it can also improve their quality of life.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects of psilocybin may include nausea, headache, increased heart rate, blood pressure changes, and psychological effects such as anxiety or hallucinations.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with Alzheimer's or Mild Cognitive Impairment.
Select...
I can attend long treatment sessions in Baltimore and follow-up meetings.
Select...
I am currently experiencing a depressive episode.
Select...
I have been diagnosed with Alzheimer's or Mild Cognitive Impairment.
Select...
I have someone close who can discuss changes in my mood and behavior for the study.
Timeline
Screening ~ 2 days2 visits
Treatment ~ Varies
Follow Up ~ 1 day3 visits
Screening ~ 2 days
Treatment ~ Varies
Follow Up ~1 day
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Cornell Scale for Depression in Dementia (CSDD) score
Secondary outcome measures
Change in Quality of Life Alzheimer's Disease (QOL-AD) scale score
Side effects data
From 2021 Phase 2 trial • 95 Patients • NCT020612939%
Nausea
7%
Pain
7%
Viral upper resp. tract infection
7%
Back pain
7%
Bronchitis
4%
Suicidal Ideation
4%
Oropharyngeal pain
4%
Insomnia
4%
Influenza
4%
Depression
4%
Diarrhea
4%
Headache
4%
Sinus headache
4%
Depressed mood
4%
Lower resp. tract congestion
4%
Alcohol withdrawal syndrome
2%
Restlessness
2%
Fungal infection
2%
Pyrexia
2%
Hypoesthesia
2%
Oedema
2%
Vomiting
2%
Rhinorrhea
2%
Musculoskeletal pain
2%
Peripheral swelling
2%
Thrombocytosis
2%
Eye infection
2%
Constipation
2%
Dermatitis contact
2%
Bronchitis bacterial
2%
Traumatic lung injury
2%
Hyponatremia
2%
Arthralgia
2%
Pain in extremity
2%
Dizziness
2%
Migraine
2%
Sedation
2%
Anger
2%
Anxiety
2%
Cough
2%
Sexual abuse
2%
Sinus congestion
2%
Malignant melanoma
2%
Endodontic procedure
2%
Mallory-Weiss Syndrom
2%
Anemia
2%
Influenza like Illness
2%
Gingivitis
2%
Arthoscopic surgery
100%
80%
60%
40%
20%
0%
Study treatment Arm
Diphenhydramine
Psilocybin
Trial Design
1Treatment groups
Experimental Treatment
Group I: PsilocybinExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psilocybin
2021
Completed Phase 2
~730
Find a Location
Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,260 Previous Clinical Trials
14,820,760 Total Patients Enrolled
57 Trials studying Depression
29,595 Patients Enrolled for Depression
Albert Garcia-Romeu, MDPrincipal InvestigatorJohns Hopkins University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been diagnosed with schizophrenia, a psychotic disorder (unless it was caused by drugs or a medical condition), or bipolar I disorder in the past or currently.I have tried various treatments for my current depressive episode, including psychotherapy, medications, and possibly ECT.I have been diagnosed with Alzheimer's or Mild Cognitive Impairment.I agree not to take medications like sildenafil within 72 hours before taking psilocybin.You have been diagnosed with depression, which can be mild or moderate based on a test called the Cornell Scale for Depression in Dementia. Or, you have been diagnosed with specific types of depression according to the DSM-5 diagnostic criteria.I am currently on antidepressants, antipsychotics, or MAO inhibitors.I have been diagnosed with depression or show signs of distress.I have no recent severe heart issues or uncontrolled high blood pressure.I have been diagnosed with early-stage Alzheimer's or mild cognitive impairment.I have a close family member with Schizophrenia, Psychotic Disorder, or Bipolar I.I have someone close who can discuss changes in my mood and behavior for the study.I have been diagnosed with early-stage Alzheimer's or mild cognitive impairment.You have a close friend or family member willing and able to serve the role of community observer / informant for data collection procedures.I am currently experiencing a depressive episode.I can attend long treatment sessions in Baltimore and follow-up meetings.I am currently experiencing a depressive episode.I have someone close who can discuss changes in my mood and behavior for the study.I have been diagnosed with Alzheimer's, early Alzheimer's, or Mild Cognitive Impairment.I can attend all required meetings in Baltimore for the study.I have been diagnosed with Alzheimer's or Mild Cognitive Impairment.I have a seizure disorder.I require insulin for my diabetes.
Research Study Groups:
This trial has the following groups:- Group 1: Psilocybin
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 2 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 10 null
- Follow Ups: You may be asked to continue sharing information regarding the trial for 1 Months after you stop receiving the treatment.
Depression Patient Testimony for trial: Trial Name: NCT04123314 — Phase < 1
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent is this research project being participated in by test subjects?
"Affirmative. The clinicaltrials.gov website verifies that this trial, initially posted on March 24th 2021, is currently enrolling participants. Up to 20 patients can be enrolled from a single facility."
Answered by AI
Are there any vacancies for participants in this trial?
"This medical study, which has been actively searching for patients since 3/24/2021 and updated as recently as 3/9/2022 according to clinicaltrials.gov, is still in the process of recruitment."
Answered by AI
Are there any analogous experiments to the current Psilocybin study?
"Currently, 33 medical studies exploring the use of Psilocybin are in progress with none at Phase 3. Most trials are situated in Vancouver, Washington but there are 36 sites across the United States participating."
Answered by AI
Could I qualify to participate in this clinical research project?
"This clinical trial seeks 20 people with Alzheimer's disease, aged between 18 and 85. All enrollees must meet one of two criteria: they either possess a mild cognitive impairment or demonstrate symptoms that qualify them for a DSM-5 diagnosis; additionally, they must have Mini Mental State Examination scores ranging from 18 to 26 (inclusive), present higher than average Cornell Scale for Depression in Dementia scores (> 6) and secure the participation of an informant who is close to them."
Answered by AI
Is this medical trial open to individuals aged twenty-five and older?
"According to the regulations of this clinical trial, persons 18 years or older and no more than 85 can participate."
Answered by AI
Who else is applying?
What state do they live in?
California
Florida
Maryland
Other
How old are they?
65+
18 - 65
What site did they apply to?
Behavioral Pharmacology Research Unit
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
2
1
0
3+
What questions have other patients asked about this trial?
How long and often are the visits? What about medications that i am on? What is the length of the trial? Is treatment daily?
PatientReceived no prior treatments
Is the only way to get accepted is to go to Baltimore? How long are the visits? Have there been good results?
PatientReceived 2+ prior treatments
Why did patients apply to this trial?
I'm just desperate. I believe i can help. My family is concerned. We find the research promising.
PatientReceived 2+ prior treatments
Sometimes my memory is not so good.
PatientReceived no prior treatments
How responsive is this trial?
Most responsive sites:
- Behavioral Pharmacology Research Unit: < 24 hours
Typically responds via
Phone Call
Email
Average response time
- < 2 Days
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