CBD for Individuals at Risk for Alzheimer's Disease
ConditionMild Cognitive Impairment
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age55-85
SponsorUniversity of Colorado, Denver
About this trial
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
Qualifiers
Must be between the ages of 55 - 85 and provide valid informed consent.
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.
Functional Activities Questionnaire (FAQ) score of 8 or less and self-reported ability to function independently.
Montreal Cognitive Assessment (MoCa) score is ≤ 25
Disqualifiers
Any other central nervous system (CNS) disease that would be expected to affect cognition, Parkinson's disease, multiple sclerosis.
History of brain injury resulting in current memory loss symptoms (e.g., concussion with significant loss of consciousness)
Any significant systemic illness or unstable medical condition
Current use of Parkinson's medications, antipsychotic medications, anti-seizure medications, or anticholinergic medications
Trial design
Treatments tested in this trial
- Cannabidiol
- Placebo
Treatment groups
236 Participants
are divided into 3 treatment groupsLocations
1University of Colorado - Anschutz Medical Campus80045, AuroraColorado, United States
Sponsors and collaborators
University of Colorado, Denver
Lead sponsor
Source ClinicalTrials.gov