CBD for Individuals at Risk for Alzheimer's Disease
Cannabidiol for Individuals at Risk for Alzheimer's Disease: A Randomized Placebo Controlled Trial
University of Colorado, Denver
236 participants
Jan 19, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria10
- 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.
- Functional Activities Questionnaire (FAQ) score of 8 or less and self-reported ability to function independently
- Montreal Cognitive Assessment (MoCa) score is between 18-25
- Participant must have a CDR score of .5 on the Clinical Dementia Rating scale (CDR), which includes an assessment of function and is often used to distinguish MCI from dementia.
- Must have an informant that will be utilized over the course of the 24 week study (must be the same person throughout study)
- 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
Exclusion Criteria14
- Any other central nervous system (CNS) disease that would be expected to affect cognition, Parkinson's disease, multiple sclerosis.
- Any history of brain injury (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 cannabis, including products with or without CBD, more than four times per month.
- 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 (hypothyroidism, Vitamin B12 deficiency).
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Interventions
The current study will directly test the hypothesis that a moderate dose of CBD improves markers of Alzheimer's progression, cognitive function, sleep, pain, anxiety, oxidative stress, and inflammation.
Placebo arm.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05822362