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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.
- Alzheimer's Disease
- Mild Cognitive Impairment
Inclusion CriteriaYou will be eligible if you check “Yes” for the criteria below
Study ObjectivesOutcome measures can provide a clearer picture of what you can expect from a treatment.
Side effects dataFrom 2021 Phase 2 trial • 95 Patients • NCT02061293
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Who is running the clinical trial?
- 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.
- Group 1: Psilocybin
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
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."
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."
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."
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."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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What questions have other patients asked about this trial?
How responsive is this trial?
Typically responds via
Most responsive sites:
- Behavioral Pharmacology Research Unit: < 24 hours
Average response time
- < 2 Days
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