CBD for Individuals at Risk for Alzheimer's Disease

• Status: Not yet recruiting
• Trial end date: 2029-04-01
• Target enrollment: 0
• Participant gender: All

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, behavioral and clinical measures, with putative mechanisms of CBD action.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Colorado, Denver
• Treatments: Cannabidiol

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 at the Memory Disorder Clinic at the University of Colorado School of Medicine

3. 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. A score of 0.5 (indicating mild cognitive impairment but not dementia) is required for inclusion.

Exclusion Criteria:

1. Any other central nervous system disease that would be expected to affect cognition, Parkinson's disease, multiple sclerosis.

2. Any history of brain injury (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 Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revised (DSM-5-TR, APA 2022)

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. Daily nicotine user

9. Report using cannabis or CBD more than once per month over the last 12 months.

10. Recent history of a psychotic disorder, bipolar disorder or meet criteria for major depression with suicidal ideation.

11. Liver function enzymes (AST, ALT) that are greater than 2x normal.

12. Currently taking medications known to be contraindicated with Epidiolex (buprenorphine, leflunomide, levomethadyl acetate, lomitapide, mipomersen, pexidartinib, propoxyphene, sodium oxybate, teriflunomide, clobazam, lamotrigine, valproate).

13. Pregnant at the time of study enrollment or unwilling to use contraception through the duration of the study (if not yet post-menopausal)

14. Individuals with potentially reversible causes of mild cognitive impairment (hypothyroidism, Vitamin B12 deficiency).