CBD for Individuals at Risk for Alzheimer's Disease (NCT05822362) | Clinical Trial Compass
RecruitingPhase 2
CBD for Individuals at Risk for Alzheimer's Disease
United States236 participantsStarted 2024-01-19
Plain-language summary
This is a double-blind, randomized controlled trial designed to test the effects of cannabidiol (CBD) on validated biomarkers of Alzheimer's disease (AD) progression, and behavioral, neurocognitive, and clinical measures, with putative mechanisms of action.
Who can participate
Age range
55 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Must be between the ages of 55 - 85 and provide valid informed consent.
. Participant must receive a diagnosis of Mild Cognitive Impairment after a careful cognitive and functional evaluation by a clinician, or have symptoms of Mild Cognitive Impairment as determined by the study physician.
. Functional Activities Questionnaire (FAQ) score of 8 or less and self-reported ability to function independently.
. Montreal Cognitive Assessment (MoCa) score is ≤ 25
. Participant must have a CDR score of .5 or 1 on the Clinical Dementia Rating scale (CDR), which includes an assessment of function and is often used to distinguish MCI from dementia. A score of 0.5 indicates mild cognitive impairment but not dementia and a score of 1 indicates mild-to-moderate cognitive impairment.
. Must have an informant that will be utilized over the course of the 24 week study (must be the same person for all CDR assessments completed via phone).
. Participant must pass a test of consent comprehension
. Must be interested in using CBD to help with cognitive function
Exclusion criteria
. Any other central nervous system (CNS) disease that would be expected to affect cognition, Parkinson's disease, multiple sclerosis.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. History of brain injury resulting in current memory loss symptoms (e.g., concussion with significant loss of consciousness)
. Any significant systemic illness or unstable medical condition
. Current use of Parkinson's medications, antipsychotic medications, anti-seizure medications, or anticholinergic medications
. Current or lifetime diagnosis of a schizophrenia spectrum disorder, psychotic disorder, bipolar disorder type I \& II, cluster B personality disorders (antisocial, borderline, narcissistic, histrionic), eating disorders, as defined by the DSM-5-TR
. Participation in other clinical studies involving neuropsychological measures being collected more than one time per year.
. Reported use of other drugs (cocaine, opiates, methamphetamine, MDMA) in the past 60 days or test positive on a urine test for those drugs of abuse at baseline.
. Report using more than 150mg of cannabis edible products per week.