Cannabidiol for Individuals at Risk for Alzheimer's Disease: A Randomized Placebo Controlled Trial
Overview
- Phase
- Phase 2
- Intervention
- Cannabidiol
- Conditions
- Mild Cognitive Impairment
- Sponsor
- University of Colorado, Denver
- Enrollment
- 236
- Locations
- 1
- Primary Endpoint
- Neurocognitive Function
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief 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.
Detailed 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, cognitive function, pain, sleep quality, anxiety, oxidative stress, and inflammation. If eligible for the study, subjects will be randomized to receive one of the conditions for 24 weeks. The current study will test the hypothesis that a moderate dose of CBD will improve measures of Alzheimer's disease progression, cognitive function, pain, sleep quality, anxiety, oxidative stress, and inflammation as compared to placebo. The study will also test whether endocannabinoids mediate the effects of CBD on these outcomes.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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.
Arms & Interventions
Full Spectrum Cannabidiol
200mg/day of full-spectrum cannabidiol, containing less than 0.3% THC.
Intervention: Cannabidiol
Broad Spectrum Cannabidiol
200mg/day of broad-spectrum cannabidiol, containing 0.0% THC.
Intervention: Cannabidiol
Hemp Seed Oil
200mg/day of hemp seed oil with no cannabinoids present.
Intervention: Placebo
Outcomes
Primary Outcomes
Neurocognitive Function
Time Frame: Week 0 to Week 24
The following assessments will be used to inform an aggregate measure of neurocognitive function: * The Clinical Dementia Rating Scale is a 5-point scale used to characterize six domains of cognitive and functional performance applicable to Alzheimer disease and related dementias. Higher scores indicate worse cognitive impairment. * NIH-Toolbox Cognitive Battery (NIH-TB CB) assessments are used to detect and measure specific aspects of cognition, including crystallized intelligence, psychomotor function, executive function, attention, and working memory. * Rey Auditory Verbal Learning Test to evaluate working memory and the Digit Symbol Substitution Task to evaluate global cognitive operations. * Montreal Cognitive Assessment (MoCa) * Functional Activities Questionnaire (FAQ) will be used to measure changes in dementia risk over the course of the clinical trial.
Biomarkers of Alzheimer's Disease Progression
Time Frame: Week 0 to Week 24
* Changes in plasma levels of N-p-tau181 will be measured in ng/dl. * Changes in plasma Aβ42/Aβ40 ratio will be measured in ng/dl. * Changes in plasma Neurofilament Light (Nfl) will be measured in ng/dl.
Secondary Outcomes
- Change in sleep(Week 0 to Week 24)
- Change in anxiety(Week 0 to Week 24)
- Change in pain(Week 0 to Week 24)
- Change in plasma lipid biomarkers of inflammation and oxidative stress(Week 0 to Week 24)