NCT05822362 · Phase 2 · RECRUITING

CBD for Individuals at Risk for Alzheimer's Disease

This trial tests whether cannabidiol (CBD), a compound from the cannabis plant, changes blood and brain markers linked to Alzheimer's progression, along with memory, thinking, and daily function. Some people get CBD, others a placebo, and no one knows which. It is a Phase 2 trial: testing whether it works and is safe, not yet proven or approved.

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're excluded 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).

The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.

Eligibility criteria as of 2026-06-15

View full record on ClinicalTrials.gov

All APOE4 clinical trials