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Cannabinoid

CBD for Alzheimer's Disease

Phase 2
Recruiting
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Able to attend in-person visits at the study site
Functional Activities Questionnaire (FAQ) score of 8 or less and self-reported ability to function independently
Must not have
Reports use of medical CBD
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 0 to week 24

Summary

This trial aims to test how CBD affects the progression of Alzheimer's disease by looking at various biomarkers and measures, using a randomized and double-blind approach.

Who is the study for?
This trial is for individuals aged 55-85 who have been diagnosed with Mild Cognitive Impairment (MCI) at the University of Colorado School of Medicine. They must show specific signs of cognitive decline but not full-blown dementia, as indicated by a score of .5 on the Clinical Dementia Rating scale.
What is being tested?
The study is testing whether cannabidiol (CBD), a compound found in cannabis plants, can slow down or affect Alzheimer's disease progression compared to a placebo. Participants won't know if they're getting CBD or the placebo in this double-blind study.
What are the potential side effects?
While not specified here, CBD may cause side effects such as tiredness, diarrhea, changes in appetite/weight and could interact with other medications. The exact side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can go to the study site for visits.
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I can do daily activities on my own and my FAQ score is 8 or less.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I use medical CBD.
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I have used drugs like cocaine or opiates in the last 60 days.
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I have been diagnosed with major depression and have had thoughts of suicide.
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I do not have any brain conditions like Parkinson's or multiple sclerosis.
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I have had a brain injury with significant loss of consciousness.
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I am not taking any medications that cannot be mixed with Epidiolex.
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I am currently taking medication for Parkinson's, seizures, psychosis, or using anticholinergics.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 0 to week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 0 to week 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Biomarkers of Alzheimer's Disease Progression
Neurocognitive Function
Secondary study objectives
Change in anxiety
Change in pain
Change in plasma lipid biomarkers of inflammation and oxidative stress
+1 more

Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: Full Spectrum CannabidiolActive Control1 Intervention
200mg/day of full-spectrum cannabidiol, containing less than 0.3% THC.
Group II: Broad Spectrum CannabidiolActive Control1 Intervention
200mg/day of broad-spectrum cannabidiol, containing 0.0% THC.
Group III: Hemp Seed OilPlacebo Group1 Intervention
200mg/day of hemp seed oil with no cannabinoids present.

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Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,806 Previous Clinical Trials
2,822,641 Total Patients Enrolled
~157 spots leftby Apr 2028
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