CBD for Individuals at Risk for Alzheimer's Disease

Last updated: September 27, 2024
Sponsor: University of Colorado, Denver
Overall Status: Active - Recruiting

Phase

2

Condition

Alzheimer's Disease

Memory Loss

Memory Problems

Treatment

Placebo

Cannabidiol

Clinical Study ID

NCT05822362
23-0619
  • Ages 55-85
  • All Genders

Study 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 Criteria

Inclusion

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 carefulcognitive and functional evaluation by a clinician.

  3. Functional Activities Questionnaire (FAQ) score of 8 or less and self-reportedability 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 fromdementia.

  6. Must have an informant that will be utilized over the course of the 24 week study (must be the same person throughout study)

  7. Participant must pass a test of consent comprehension

  8. Must be interested in using CBD to help with cognitive function

  9. Must plan on living in the Denver metro area over the next 6 months

  10. Able to attend in-person visits at the study site

Exclusion

Exclusion Criteria:

  1. Any other central nervous system (CNS) disease that would be expected to affectcognition, Parkinson's disease, multiple sclerosis.

  2. Any history of brain injury (e.g., concussion with significant loss ofconsciousness)

  3. Any significant systemic illness or unstable medical condition

  4. Current use of Parkinson's medications, antipsychotic medications, anti-seizuremedications, or anticholinergic medications

  5. Current or lifetime diagnosis of a schizophrenia spectrum disorder, psychoticdisorder, bipolar disorder type I & II, cluster B personality disorders (antisocial,borderline, narcissistic, histrionic), eating disorders, as defined by the DSM-5-TR

  6. Participation in other clinical studies involving neuropsychological measures beingcollected more than one time per year.

  7. Reported use of other drugs (cocaine, opiates, methamphetamine, MDMA) in the past 60days or test positive on a urine test for those drugs of abuse at baseline.

  8. Report using cannabis, including products with or without CBD, more than four timesper month.

  9. Recent history of, or meets criteria for major depression with suicidal ideation.

  10. Reports use of medical CBD.

  11. Liver function enzymes (AST, ALT) that are greater than 2x normal.

  12. Currently taking medications known to be contraindicated with Epidiolex (buprenorphine, leflunomide, levomethadyl acetate, lomitapide, mipomersen,pexidartinib, propoxyphene, sodium oxybate, teriflunomide, clobazam, lamotrigine,valproate).

  13. Pregnant at the time of study enrollment or unwilling to use contraception throughthe duration of the study (if not yet post-menopausal)

  14. Individuals with potentially reversible causes of mild cognitive impairment (hypothyroidism, Vitamin B12 deficiency).

Study Design

Total Participants: 236
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
January 19, 2024
Estimated Completion Date:
April 30, 2029

Study 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.

Connect with a study center

  • University of Colorado - Anschutz Medical Campus

    Aurora, Colorado 80045
    United States

    Active - Recruiting

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