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

Status: Recruiting
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 55
Maximum Age: 85
Healthy Volunteers: f
View:

• 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.

• Functional Activities Questionnaire (FAQ) score of 8 or less and self-reported ability 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 from dementia.

• 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

Locations
United States
Colorado
University of Colorado - Anschutz Medical Campus
RECRUITING
Aurora
Contact Information
Primary
Raeghan Mueller, PhD
raeghan.mueller@cuanschutz.edu
3037242210
Time Frame
Start Date: 2024-01-19
Estimated Completion Date: 2029-04
Participants
Target number of participants: 236
Treatments
Active_comparator: Full Spectrum Cannabidiol
200mg/day of full-spectrum cannabidiol, containing less than 0.3% THC.
Active_comparator: Broad Spectrum Cannabidiol
200mg/day of broad-spectrum cannabidiol, containing 0.0% THC.
Placebo_comparator: Hemp Seed Oil
200mg/day of hemp seed oil with no cannabinoids present.
Related Therapeutic Areas
Sponsors
Leads: University of Colorado, Denver

This content was sourced from clinicaltrials.gov