CBD for Individuals at Risk for Alzheimer's Disease

Prior treatment

• 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.

Other illness

• 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
• Recent history of, or meets criteria for major depression with suicidal ideation.
• Individuals with potentially reversible causes of mild cognitive impairment (i.e., hypothyroidism, Vitamin B12 deficiency).

Lab values

• 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).

Other

• Participation in other clinical studies involving neuropsychological measures being collected more than one time per year.
• 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.
• Reports use of medical CBD.
• Pregnant at the time of study enrollment or unwilling to use contraception through the duration of the study (if not yet post-menopausal)

• 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