Using CBD to help individuals at risk for Alzheimer's disease
Cannabidiol for Individuals at Risk for Alzheimer's Disease: A Randomized Placebo Controlled Trial
This study is testing whether different types of CBD can help people with mild cognitive impairment feel better and slow down the progression of Alzheimer's disease.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 236 (estimated) |
| Ages | 55 Years to 85 Years |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Drugs / interventions | pexidartinib |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT05822362 on ClinicalTrials.gov |
What this trial studies
This Phase II clinical trial investigates the effects of cannabidiol (CBD) on individuals diagnosed with mild cognitive impairment (MCI). Participants will be randomly assigned to receive either Full Spectrum CBD, Broad Spectrum CBD, or a placebo for 24 weeks. The study aims to evaluate changes in biomarkers of Alzheimer's disease progression, cognitive function, and various health measures such as pain and sleep quality. The trial is designed to be double-blind and placebo-controlled to ensure the reliability of results.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 55-85 with a diagnosis of mild cognitive impairment and a willingness to use CBD for cognitive enhancement.
Not a fit: Patients with severe cognitive impairment or those not residing in the Denver metro area may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel therapeutic option for improving cognitive function and slowing the progression of Alzheimer's disease.
How similar studies have performed: While there is emerging interest in the use of CBD for cognitive health, this specific approach is relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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 Criteria: 1. Any other central nervous system (CNS) disease that would be expected to affect cognition, Parkinson's disease, multiple sclerosis. 2. Any history of brain injury (e.g., concussion with significant loss of consciousness) 3. Any significant systemic illness or unstable medical condition 4. Current use of Parkinson's medications, antipsychotic medications, anti-seizure medications, or anticholinergic medications 5. 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 6. Participation in other clinical studies involving neuropsychological measures being collected more than one time per year. 7. 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. 8. Report using cannabis, including products with or without CBD, more than four times per 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 through the duration of the study (if not yet post-menopausal) 14. Individuals with potentially reversible causes of mild cognitive impairment (hypothyroidism, Vitamin B12 deficiency).
Where this trial is running
Aurora, Colorado
- University of Colorado - Anschutz Medical Campus — Aurora, Colorado, United States (Recruiting)
Study contacts
- Study coordinator: Raeghan Mueller, PhD
- Email: raeghan.mueller@cuanschutz.edu
- Phone: 3037242210
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.