NCT05822362 · University of Colorado, Denver
CBD for Individuals at Risk for Alzheimer's Disease
What this study is about
This is a where neither patients nor doctors know which treatment is given, randomly assigned 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.
View original scientific 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.
Interventions
DRUG
Cannabidiol
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.
OTHER
Placebo
Placebo arm.
Primary outcome measures
Neurocognitive Function
Time frame: Week 0 to Week 24
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.
Biomarkers of Alzheimer's Disease Progression
Time frame: Week 0 to Week 24
* 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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, or have symptoms of Mild Cognitive Impairment as determined by the study physician.
- Functional Activities Questionnaire (FAQ) score of 8 or less and self-reported ability to function independently.
- Montreal Cognitive Assessment (MoCa) score is ≤ 25
- Participant must have a CDR score of .5 or 1 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 indicates mild cognitive impairment but not dementia and a score of 1 indicates mild-to-moderate cognitive impairment.
- Must have an informant that will be utilized over the course of the 24 week study (must be the same person for all CDR assessments completed via phone).
- 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
Exclusion criteria
- Any other central nervous system (CNS) disease that would be expected to affect cognition, Parkinson's disease, multiple sclerosis.
- History of brain injury resulting in current memory loss symptoms (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 more than 150mg of cannabis edible products per week.
- Report using more than 7 grams of cannabis flower product (not including CBD) per week.
- 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 (i.e., hypothyroidism, Vitamin B12 deficiency).
Where
- Aurora, Colorado
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 15, 2026 · Source of record for eligibility and locations