Cannabidiol for Individuals at Risk for Alzheimer's Disease: A Randomized Placebo Controlled Trial
University of Colorado, Denver
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.
Description
To better understand the effects of hemp-derived CBD with and without a small amount of THC, we propose a Phase II randomized clinical trial (RCT) to examine the clinical effects of Full Spectrum CBD (fsCBD, contains less than 0.3% THC) vs. Broad Spectrum CBD (bsCBD, does not contain THC), vs. a matching placebo in a population of individuals diagnosed with mild cognitive impairment (MCI). This is a double-blind, placebo-controlled, parallel group study designed to assess the efficacy of fsCBD and bsCBD, compared to a placebo control, on biomarkers of Alzheimer's disease progression, cognitiv…
Eligibility
- Age range
- 55–85 years
- Sex
- All
- Healthy volunteers
- No
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. 3. Functional Activities Questionnaire (FAQ) score of 8 or less and self-reported ability to function independently 4. Montreal Cognitive Assessment (MoCa) score is between 18-25 5. 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. 6. Must…
Interventions
- DrugCannabidiol
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.
- OtherPlacebo
Placebo arm.
Location
- University of Colorado - Anschutz Medical CampusAurora, Colorado