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CBD for Individuals at Risk for Alzheimer's Disease
Cannabidiol for Individuals at Risk for Alzheimer's Disease: A Randomized Placebo Controlled Trial
Lead sponsor
Asset
Cannabidiol
Listed sites
1
Recruiting sites
1
Enrollment
236
estimated
Study population
Alzheimer’s disease, MCI / preclinical Alzheimer’s
Key I/E criterion
•MoCA ≤25
Primary endpoints
•Montreal Cognitive Assessment (MoCA)•Phosphorylated tau 181 (p-tau181)
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Drug assets
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Must be between the ages of 55 - 85 and provide valid informed consent.
2. 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.
3. Functional Activities Questionnaire (FAQ) score of 8 or less and self-reported ability to function independently.
4. Montreal Cognitive Assessment (MoCa) score is ≤ 25
5. 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.
6. 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).
7. Participant must pass a test of consent comprehension
8. Must be interested in using CBD to help with cognitive function
9. Must plan on living in the Denver metro area over the next 6 months
10. Able to attend in-person visits at the study site
Exclusion criteria
1. Any other central nervous system (CNS) disease that would be expected to affect cognition, Parkinson's disease, multiple sclerosis.
2. History of brain injury resulting in current memory loss symptoms (e.g., concussion with significant loss of consciousness)
3. Any significant systemic illness or unstable medical condition
4. Current use of Parkinson's medications, antipsychotic medications, anti-seizure medications, or anticholinergic medications
5. 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
6. Participation in other clinical studies involving neuropsychological measures being collected more than one time per year.
7. 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.
8. Report using more than 150mg of cannabis edible products per week.
9. Report using more than 7 grams of cannabis flower product (not including CBD) per week.
10. Recent history of, or meets criteria for major depression with suicidal ideation.
11. Reports use of medical CBD.
12. Liver function enzymes (AST, ALT) that are greater than 2x normal.
13. Currently taking medications known to be contraindicated with Epidiolex (buprenorphine, leflunomide, levomethadyl acetate, lomitapide, mipomersen, pexidartinib, propoxyphene, sodium oxybate, teriflunomide, clobazam, lamotrigine, valproate).
14. Pregnant at the time of study enrollment or unwilling to use contraception through the duration of the study (if not yet post-menopausal)
15. Individuals with potentially reversible causes of mild cognitive impairment (i.e., hypothyroidism, Vitamin B12 deficiency).
Endpoints (6)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Global cognition
1 endpointNeurocognitive Function
Time frame:Week 0 to Week 24
Montreal Cognitive Assessment (MoCA)
ratio, descriptive
Behavior / neuropsychiatric
2 endpointsChange in sleep
Time frame:Week 0 to Week 24
change from baseline, improvement
Change in anxiety
Time frame:Week 0 to Week 24
change from baseline, improvement
Disease progression
1 endpointBiomarkers of Alzheimer's Disease Progression
Time frame:Week 0 to Week 24
Phosphorylated tau 181 (p-tau181)
ratio, descriptive
Other (unclassified)
2 endpointsChange in pain
Time frame:Week 0 to Week 24
change from baseline, improvement
Change in plasma lipid biomarkers of inflammation and oxidative stress
Time frame:Week 0 to Week 24
change from baseline, improvement
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.