Using CBD to help individuals at risk for Alzheimer's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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, or have symptoms of Mild Cognitive Impairment as determined by the study physician.
3. Functional Activities Questionnaire (FAQ) score of 8 or less and self-reported ability to function independently.
4. Montreal Cognitive Assessment (MoCa) score is ≤ 25
5. Participant must have a CDR score of .5 or 1 on the Clinical Dementia Rating scale (CDR), which includes an assessment of function and is often used to distinguish MCI from dementia. A score of 0.5 indicates mild cognitive impairment but not dementia and a score of 1 indicates mild-to-moderate cognitive impairment.
6. Must have an informant that will be utilized over the course of the 24 week study (must be the same person for all CDR assessments completed via phone).
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. History of brain injury resulting in current memory loss symptoms (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 more than 150mg of cannabis edible products per week.
9. Report using more than 7 grams of cannabis flower product (not including CBD) per week.
10. Recent history of, or meets criteria for major depression with suicidal ideation.
11. Reports use of medical CBD.
12. Liver function enzymes (AST, ALT) that are greater than 2x normal.
13. Currently taking medications known to be contraindicated with Epidiolex (buprenorphine, leflunomide, levomethadyl acetate, lomitapide, mipomersen, pexidartinib, propoxyphene, sodium oxybate, teriflunomide, clobazam, lamotrigine, valproate).
14. Pregnant at the time of study enrollment or unwilling to use contraception through the duration of the study (if not yet post-menopausal)
15. Individuals with potentially reversible causes of mild cognitive impairment (i.e., hypothyroidism, Vitamin B12 deficiency).

Where it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• One-day exercise test to see how brain and body react in epilepsy, cognitive disorders, Parkinson's, dementia, and related conditions

  A one-day study tests how an acute bout of exercise changes brain function and bodily signals in people with certain neurological conditions compared with healthy individuals.

  Recruiting Brigham and Women's Hospital · Boston, Massachusetts · NCT07883720

• Choose Myself (Before) Losing Myself

  We’re testing an educational interactive booklet to help people with dementia or memory problems think about future medical decisions and start conversations with family or caregivers.

  Recruiting The Cleveland Clinic · Cleveland, Ohio · NCT07846566

• Gut and Oral Microbiome and Cognitive Health in Aging

  This study tests whether differences in gut and mouth bacteria are linked to cognitive health in adults across ages and cognitive status.

  Recruiting University of South Florida · Tampa, Florida · NCT07799402

• Gut methane and Parkinson's: measuring if a probiotic helps people with Parkinson's, REM sleep behavior disorder, or cognitive concerns

  This study tests whether a probiotic containing Limosilactobacillus reuteri can help people with Parkinson's disease, those at high risk for PD, and related cognitive issues by potentially improving gut methane levels and overall symptoms.

  Recruiting University of Cambridge · Cambridge, CB2 · NCT07786116

• AI-supported sleep program for people with mild cognitive impairment or dementia

  A small randomized trial tests an AI-assisted behavioral sleep program to help people with mild cognitive impairment or mild dementia who have sleep problems.

  Recruiting The Hong Kong Polytechnic University · Kowloon, Hung Hom · NCT07784946

• Binaural beats for cognitive function in older adults with mild cognitive impairment in nursing homes

  This study tests whether listening to 10-Hz binaural beats for 30 minutes daily for 14 days can help cognitive function in older adults with mild cognitive impairment living in nursing homes.

  Recruiting at 3 sites China Medical University, China · Shenyang, Liaoning and 2 other locations · NCT07735910

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.