RECRUITING

CBD for Individuals at Risk for Alzheimer's Disease

Conditions

Mild Cognitive Impairment Cognition Cannabidiol Aging Memory Alzheimer's Disease CBD MCI Cognitive decline Healthy aging Older adults Brain Cannabis Marijuana

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-01-19

Study Completion:2029-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05822362

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:55 Years to 85 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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. 3. Functional Activities Questionnaire (FAQ) score of 8 or less and self-reported ability to function independently 4. Montreal Cognitive Assessment (MoCa) score is between 18-25 5. 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. 6. Must have an informant that will be utilized over the course of the 24 week study (must be the same person throughout study) 7. Participant must pass a test of consent comprehension 8. Must be interested in using CBD to help with cognitive function 9. Must plan on living in the Denver metro area over the next 6 months 10. Able to attend in-person visits at the study site	1. Any other central nervous system (CNS) 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 the DSM-5-TR 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. Report using cannabis, including products with or without CBD, more than four times per month. 9. Recent history of, or meets criteria for major depression with suicidal ideation. 10. Reports use of medical CBD. 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).

Inclusion Criteria

Exclusion 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.
3. Functional Activities Questionnaire (FAQ) score of 8 or less and self-reported ability to function independently
4. Montreal Cognitive Assessment (MoCa) score is between 18-25
5. 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.
6. Must have an informant that will be utilized over the course of the 24 week study (must be the same person throughout study)
7. Participant must pass a test of consent comprehension
8. Must be interested in using CBD to help with cognitive function
9. Must plan on living in the Denver metro area over the next 6 months
10. Able to attend in-person visits at the study site

1. Any other central nervous system (CNS) 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 the DSM-5-TR
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. Report using cannabis, including products with or without CBD, more than four times per month.
9. Recent history of, or meets criteria for major depression with suicidal ideation.
10. Reports use of medical CBD.
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).

Contacts and Locations

Study Contact

Raeghan Mueller, PhD

CONTACT

3037242210

raeghan.mueller@cuanschutz.edu

Study Locations (Sites)

University of Colorado - Anschutz Medical Campus

Aurora, Colorado, 80045

United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-19

Study Completion Date2029-04

Study Record Updates

Study Start Date2024-01-19

Study Completion Date2029-04

Terms related to this study

Keywords Provided by Researchers

Cognition
Cannabidiol
Aging
Memory
Alzheimer's Disease
CBD
MCI
Mild Cognitive Impairment
Cognitive decline
Healthy aging
Older adults
Brain
Cannabis
Marijuana

Additional Relevant MeSH Terms

Mild Cognitive Impairment