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RecruitingPhase 2

CBD for Individuals at Risk for Alzheimer's Disease

Cannabidiol for Individuals at Risk for Alzheimer's Disease: A Randomized Placebo Controlled Trial

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
55 Years to 85 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 24 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "If eligible for the study, subjects will be randomized to receive one of the conditions for 24 weeks."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how cannabidiol (CBD) affects signs of Alzheimer's disease, thinking, behavior, and health. It is for adults ages 55–85 who have mild problems with memory or thinking and may be at risk for Alzheimer's disease.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 55–85, agree to join, and pass a test showing you understand what joining means.
  • Have mild cognitive impairment (memory or thinking problems), or symptoms confirmed by the study doctor.
  • Be able to live independently and score 8 or less on the Functional Activities Questionnaire, a daily-task survey.
  • Score 25 or less on the Montreal Cognitive Assessment, a thinking and memory test.
  • Have a Clinical Dementia Rating score of 0.5 or 1, which measures thinking problems and daily function.
  • Have the same person available throughout the 24-week study to answer phone questions about your thinking and daily function.
  • Be interested in using CBD to help with thinking and memory.
  • Plan to live in the Denver metro area for the next 6 months and attend study visits in person.

Who can't join

  • Have another brain or nervous system disease that affects thinking, such as Parkinson's disease or multiple sclerosis; a past brain injury that still causes memory loss; or a treatable cause of thinking problems, such as low thyroid hormone or low vitamin B12.
  • Have a serious illness, an unstable health condition, or liver enzyme blood test results more than twice the normal level.
  • Have a current or past diagnosis of schizophrenia or a related disorder, psychosis (trouble knowing what is real), bipolar I or II disorder, an eating disorder, or certain personality disorders (antisocial, borderline, narcissistic, or histrionic). Recent or current major depression with thoughts of suicide also rules out joining.
  • Take medicines for Parkinson's disease, psychosis, or seizures, or anticholinergic medicines, which block a chemical messenger in the body.
  • Take medicines that cannot be used with Epidiolex: buprenorphine, leflunomide, levomethadyl acetate, lomitapide, mipomersen, pexidartinib, propoxyphene, sodium oxybate, teriflunomide, clobazam, lamotrigine, or valproate.
  • Have used cocaine, opiates, methamphetamine, or MDMA in the past 60 days, or test positive for them at the start. Also excluded: medical CBD use, more than 150 mg of cannabis edibles per week, or more than 7 grams of cannabis flower per week, not counting CBD.
  • Take part in another study that gives thinking and memory tests more than once a year.
  • Be pregnant when joining, or be unwilling to use birth control during the study if you have not yet gone through menopause.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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, 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).

Study sites (1)

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