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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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?
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.
Must not have
Be younger than 18 years old
Timeline
Screening 2 days
Treatment Varies
Follow Up1 day
Awards & highlights
No Placebo-Only Group
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.
Eligible Conditions
- Depression
- Alzheimer's Disease
- Mild Cognitive Impairment
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowTimeline
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 • NCT0206129344%
Headache
21%
Nausea
15%
Anxiety
8%
Suicidal Ideation
6%
Insomnia
6%
Depressed mood
4%
Abdominal pain upper
4%
Vomiting
4%
Corona virus infection
4%
Upper respiratory tract infection
4%
Viral upper resp. tract infection
4%
Alcohol poisoning
4%
Depression
4%
Pneumonia
2%
Illusion
2%
Urinary incontinence
2%
Biopsy cervix
2%
Palpitations
2%
Cataract
2%
Abdominal pain
2%
Toothache
2%
Pain
2%
Limb injury
2%
Muscle strain
2%
Blood pressure diastolic increased
2%
Blood pressure increased
2%
Back pain
2%
Musculoskeletal pain
2%
Myalgia
2%
Dizziness
2%
Psychomotor hyperactivity
2%
Alcohol withdrawal syndrome
2%
Dysphoria
2%
Testicular pain
2%
Hyperventilation
2%
Food poisoning
2%
Food allergy
2%
Dyspepsia
2%
Influenza
2%
Nasal congestion
2%
Skin cosmetic procedure
2%
Photopsia
2%
Diverticulitis
2%
Asthenia
2%
Fatigue
2%
Gingivitis
2%
Dyspnea
2%
Oropharyngeal pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Psilocybin
Diphenhydramine
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
~720
Find a Location
Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,192 Previous Clinical Trials
14,803,404 Total Patients Enrolled
54 Trials studying Depression
29,506 Patients Enrolled for Depression
Albert Garcia-Romeu, MDPrincipal InvestigatorJohns Hopkins University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a close friend or family member willing and able to serve the role of community observer / informant for data collection procedures.You have a condition that causes seizures.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.You have been diagnosed with mild Alzheimer's disease or mild cognitive impairment (MCI) with memory problems confirmed by a test.You have heart-related conditions such as chest pain or abnormal heart rhythm, history of stroke or mini-stroke, artificial heart valves, or high blood pressure that is not well controlled.A parent, sibling or child of yours has a history of Schizophrenia, Psychotic Disorder (unless caused by drugs or a medical condition), or Bipolar I Disorder.You are currently taking drugs for depression, antipsychotics, or Monoamine Oxidase (MAO) inhibitors.You cannot take certain medications used to treat erectile dysfunction within 72 hours of receiving psilocybin, as it can cause a dangerous drop in blood pressure.You have diabetes and require insulin for treatment.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.You have been diagnosed with a type of depression by a doctor or have a score higher than 6 on the Cornell Scale for Depression in Dementia.
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 impairmenth 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+
Why did patients apply to this trial?
I believe i can help. My family is concerned. We find the research promising.
PatientReceived no prior treatments
Sometimes my memory is not so good. Want to know my changes of developing.
PatientReceived no prior treatments
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
How responsive is this trial?
Typically responds via
Phone Call
Email
Most responsive sites:
- Behavioral Pharmacology Research Unit: < 24 hours
Average response time
- < 2 Days
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