Phase
Condition
Alzheimer's Disease
Memory Loss
Memory Problems
Treatment
Placebo
Cannabidiol
Clinical Study ID
Ages 55-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 carefulcognitive and functional evaluation by a clinician.
Functional Activities Questionnaire (FAQ) score of 8 or less and self-reportedability 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 fromdementia.
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
Exclusion Criteria:
Any other central nervous system (CNS) disease that would be expected to affectcognition, Parkinson's disease, multiple sclerosis.
Any history of brain injury (e.g., concussion with significant loss ofconsciousness)
Any significant systemic illness or unstable medical condition
Current use of Parkinson's medications, antipsychotic medications, anti-seizuremedications, or anticholinergic medications
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
Participation in other clinical studies involving neuropsychological measures beingcollected more than one time per year.
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.
Report using cannabis, including products with or without CBD, more than four timesper month.
Recent history of, or meets criteria for major depression with suicidal ideation.
Reports use of medical CBD.
Liver function enzymes (AST, ALT) that are greater than 2x normal.
Currently taking medications known to be contraindicated with Epidiolex (buprenorphine, leflunomide, levomethadyl acetate, lomitapide, mipomersen,pexidartinib, propoxyphene, sodium oxybate, teriflunomide, clobazam, lamotrigine,valproate).
Pregnant at the time of study enrollment or unwilling to use contraception throughthe duration of the study (if not yet post-menopausal)
Individuals with potentially reversible causes of mild cognitive impairment (hypothyroidism, Vitamin B12 deficiency).
Study Design
Study Description
Connect with a study center
University of Colorado - Anschutz Medical Campus
Aurora, Colorado 80045
United StatesActive - Recruiting
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