CBD for Individuals at Risk for Alzheimer's Disease

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Mild Cognitive Impairment

In brief

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.

Key facts

Study ID

NCT05822362

Run by

University of Colorado, Denver

People needed

236

Starts

2024-01-19

Expected to finish

2029-04-01

Last updated by the study team

2026-06-15

Who can join

Age: 55 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Must plan on living in the Denver metro area over the next 6 months
• Able to attend in-person visits at the study site

You may not qualify if…

• Any other central nervous system (CNS) disease that would be expected to affect cognition, Parkinson's disease, multiple sclerosis.
• 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.
• Report using more than 7 grams of cannabis flower product (not including CBD) per week.
• Recent history of, or meets criteria for major depression with suicidal ideation.
• Reports use of medical CBD.
• Liver function enzymes (AST, ALT) that are greater than 2x normal.
• Currently taking medications known to be contraindicated with Epidiolex (buprenorphine, leflunomide, levomethadyl acetate, lomitapide, mipomersen, pexidartinib, propoxyphene, sodium oxybate, teriflunomide, clobazam, lamotrigine, valproate).
• Pregnant at the time of study enrollment or unwilling to use contraception through the duration of the study (if not yet post-menopausal)
• Individuals with potentially reversible causes of mild cognitive impairment (i.e., hypothyroidism, Vitamin B12 deficiency).

Where it is running

• University of Colorado - Anschutz Medical Campus — Aurora, Colorado, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.