CBD for Individuals at Risk for Alzheimer's Disease

NCT05822362 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 23-0619
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mild Cognitive Impairment

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Neurocognitive Function

  The following assessments will be used to inform an aggregate measure of neurocognitive function: * The Clinical Dementia Rating Scale is a 5-point scale used to characterize six domains of cognitive and functional performance applicable to Alzheimer disease and related dementias. Higher scores indicate worse cognitive impairment. * NIH-Toolbox Cognitive Battery (NIH-TB CB) assessments are used to detect and measure specific aspects of cognition, including crystallized intelligence, psychomotor function, executive function, attention, and working memory. * Rey Auditory Verbal Learning Test to evaluate working memory and the Digit Symbol Substitution Task to evaluate global cognitive operations. * Montreal Cognitive Assessment (MoCa) * Functional Activities Questionnaire (FAQ) will be used to measure changes in dementia risk over the course of the clinical trial.

  Week 0 to Week 24

• Biomarkers of Alzheimer's Disease Progression

  * Changes in plasma levels of N-p-tau181 will be measured in ng/dl. * Changes in plasma Aβ42/Aβ40 ratio will be measured in ng/dl. * Changes in plasma Neurofilament Light (Nfl) will be measured in ng/dl.

  Week 0 to Week 24

Secondary Outcomes (4)

• Change in pain

  Week 0 to Week 24

• Change in sleep

  Week 0 to Week 24

• Change in anxiety

  Week 0 to Week 24

• Change in plasma lipid biomarkers of inflammation and oxidative stress

  Week 0 to Week 24

Study Arms (3)

Full Spectrum Cannabidiol

ACTIVE COMPARATOR

200mg/day of full-spectrum cannabidiol, containing less than 0.3% THC.

Drug: Cannabidiol

Broad Spectrum Cannabidiol

ACTIVE COMPARATOR

200mg/day of broad-spectrum cannabidiol, containing 0.0% THC.

Drug: Cannabidiol

Hemp Seed Oil

PLACEBO COMPARATOR

200mg/day of hemp seed oil with no cannabinoids present.

Other: Placebo

Interventions

Cannabidiol DRUG

The current study will directly test the hypothesis that a moderate dose of CBD improves markers of Alzheimer's progression, cognitive function, sleep, pain, anxiety, oxidative stress, and inflammation.

Also known as: CBD

Broad Spectrum Cannabidiol; Full Spectrum Cannabidiol

Placebo OTHER

Placebo arm.

Hemp Seed Oil

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Any other central nervous system (CNS) disease that would be expected to affect cognition, Parkinson's disease, multiple sclerosis.
• Any history of brain injury (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
• 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
• Participation in other clinical studies involving neuropsychological measures being collected more than one time per year.
• 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.
• Report using cannabis, including products with or without CBD, more than four times per month.
• Recent history of, or meets criteria for major depression with suicidal ideation.
• Reports use of medical CBD.
• Liver function enzymes (AST, ALT) that are greater than 2x normal.
• Currently taking medications known to be contraindicated with Epidiolex (buprenorphine, leflunomide, levomethadyl acetate, lomitapide, mipomersen, pexidartinib, propoxyphene, sodium oxybate, teriflunomide, clobazam, lamotrigine, valproate).
• Pregnant at the time of study enrollment or unwilling to use contraception through the duration of the study (if not yet post-menopausal)
• Individuals with potentially reversible causes of mild cognitive impairment (hypothyroidism, Vitamin B12 deficiency).

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado - Anschutz Medical Campus

Aurora, Colorado, 80045, United States

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease; Marijuana Abuse

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Substance-Related Disorders; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Central Study Contacts

Raeghan Mueller, PhD

CONTACT

3037242210; raeghan.mueller@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a double-blind, placebo-controlled, parallel group study.

Study Record Dates

• First Submitted: April 7, 2023
• First Posted: April 20, 2023
• Study Start: January 19, 2024
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2029
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)