Actively Recruiting
CBD for Individuals at Risk for Alzheimer's Disease
Led by University of Colorado, Denver · Updated on 2024-10-01
236
Participants Needed
1
Research Sites
271 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
CBD for Individuals at Risk for Alzheimer's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Between 55 and 85 years old and able to provide informed consent
- Diagnosed with mild cognitive impairment after clinical evaluation
- Functional Activities Questionnaire score of 8 or less and able to function independently
- Montreal Cognitive Assessment score between 18 and 25
- Clinical Dementia Rating score of 0.5
- Have an informant available for the 24-week study period
- Pass a test of consent understanding
- Interested in using CBD for cognitive function
- Plan to live in the Denver metro area for the next 6 months
- Able to attend in-person study visits
You will not qualify if you...
- Presence of other central nervous system diseases affecting cognition, such as Parkinson's disease or multiple sclerosis
- History of brain injury with significant loss of consciousness
- Significant systemic illness or unstable medical condition
- Current use of Parkinson's, antipsychotic, anti-seizure, or anticholinergic medications
- Diagnosis of schizophrenia spectrum, psychotic, bipolar I or II, cluster B personality, or eating disorders
- Participation in other neuropsychological clinical studies more than once per year
- Use of illicit drugs (cocaine, opiates, methamphetamine, MDMA) in the past 60 days or positive drug test
- Use of cannabis products more than four times per month
- Recent major depression with suicidal thoughts
- Use of medical CBD
- Liver enzyme levels greater than twice normal
- Currently taking medications contraindicated with Epidiolex
- Pregnant or unwilling to use contraception during the study if not post-menopausal
- Reversible causes of mild cognitive impairment such as hypothyroidism or Vitamin B12 deficiency
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Colorado - Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Actively Recruiting
Research Team
R
Raeghan Mueller, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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