Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
236 participants
INTERVENTIONAL
2024-01-19
2029-04-30
Brief Summary
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Detailed Description
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This is a double-blind, placebo-controlled, parallel group study designed to assess the efficacy of fsCBD and bsCBD, compared to a placebo control, on biomarkers of Alzheimer's disease progression, cognitive function, pain, sleep quality, anxiety, oxidative stress, and inflammation. If eligible for the study, subjects will be randomized to receive one of the conditions for 24 weeks.
The current study will test the hypothesis that a moderate dose of CBD will improve measures of Alzheimer's disease progression, cognitive function, pain, sleep quality, anxiety, oxidative stress, and inflammation as compared to placebo. The study will also test whether endocannabinoids mediate the effects of CBD on these outcomes.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Full Spectrum Cannabidiol
200mg/day of full-spectrum cannabidiol, containing less than 0.3% THC.
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.
Broad Spectrum Cannabidiol
200mg/day of broad-spectrum cannabidiol, containing 0.0% THC.
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.
Hemp Seed Oil
200mg/day of hemp seed oil with no cannabinoids present.
Placebo
Placebo arm.
Interventions
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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.
Placebo
Placebo arm.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
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).
55 Years
85 Years
ALL
No
Sponsors
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University of Colorado, Denver
OTHER
Responsible Party
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Locations
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University of Colorado - Anschutz Medical Campus
Aurora, Colorado, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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23-0619
Identifier Type: -
Identifier Source: org_study_id
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