Actively Recruiting

Phase 2
Age: 55Years - 85Years
All Genders
NCT05822362

CBD for Individuals at Risk for Alzheimer's Disease

Led by University of Colorado, Denver · Updated on 2024-10-01

236

Participants Needed

1

Research Sites

271 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

CBD for Individuals at Risk for Alzheimer's Disease

Who Can Participate

Age: 55Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Between 55 and 85 years old and able to provide informed consent
  • Diagnosed with mild cognitive impairment after clinical evaluation
  • Functional Activities Questionnaire score of 8 or less and able to function independently
  • Montreal Cognitive Assessment score between 18 and 25
  • Clinical Dementia Rating score of 0.5
  • Have an informant available for the 24-week study period
  • Pass a test of consent understanding
  • Interested in using CBD for cognitive function
  • Plan to live in the Denver metro area for the next 6 months
  • Able to attend in-person study visits
Not Eligible

You will not qualify if you...

  • Presence of other central nervous system diseases affecting cognition, such as Parkinson's disease or multiple sclerosis
  • History of brain injury with significant loss of consciousness
  • Significant systemic illness or unstable medical condition
  • Current use of Parkinson's, antipsychotic, anti-seizure, or anticholinergic medications
  • Diagnosis of schizophrenia spectrum, psychotic, bipolar I or II, cluster B personality, or eating disorders
  • Participation in other neuropsychological clinical studies more than once per year
  • Use of illicit drugs (cocaine, opiates, methamphetamine, MDMA) in the past 60 days or positive drug test
  • Use of cannabis products more than four times per month
  • Recent major depression with suicidal thoughts
  • Use of medical CBD
  • Liver enzyme levels greater than twice normal
  • Currently taking medications contraindicated with Epidiolex
  • Pregnant or unwilling to use contraception during the study if not post-menopausal
  • Reversible causes of mild cognitive impairment such as hypothyroidism or Vitamin B12 deficiency

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Colorado - Anschutz Medical Campus

Aurora, Colorado, United States, 80045

Actively Recruiting

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Research Team

R

Raeghan Mueller, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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