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Cannabinoid

Full Spectrum Cannabidiol for Mild Cognitive Impairment

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 0 to week 24

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I can go to the study site for visits.

Select...

I can do daily activities on my own and my FAQ score is 8 or less.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 0 to week 24

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Biomarkers of Alzheimer's Disease Progression

Neurocognitive Function

Secondary outcome measures

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor

1,746 Previous Clinical Trials

2,163,887 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What specific criteria should be considered when selecting participants for this research endeavor?

"For this research endeavor, the aim is to enroll 236 individuals experiencing mild cognitive impairment within the age range of 55 and 85. Notably, potential participants must adhere to specific criteria: Being aged between 55 - 85 and granting valid informed consent., Candidates are expected to have received a diagnosis indicating Mild Cognitive Impairment following an in-depth cognitive and functional assessment conducted by a clinician from the Memory Disorder Clinic at the University of Colorado School of Medicine. Furthermore, applicants should exhibit a CDR score of .5 on the Clinical Dementia Rating scale (CDR), which evaluates functionality and is commonly utilized to distinguish MCI"

Answered by AI

Are individuals currently able to apply and participate in this ongoing research study?

"As per the information provided on clinicaltrials.gov, this investigation is actively pursuing participants. The trial was first listed on January 19th, 2024, and last revised on February 2nd of the same year."

Answered by AI

Do individuals who have surpassed the age of 55 meet the criteria for participation in this research?

"To be eligible for this study, participants must fall between the ages of 55 and 85 years old."

Answered by AI

Has the FDA granted approval for Full Spectrum Cannabidiol?

"Based on our evaluation at Power, the safety rating for Full Spectrum Cannabidiol is a 2. This assessment stems from it being a Phase 2 trial with existing safety data but lacking efficacy evidence."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

CBD for Individuals at Risk for Alzheimer's Disease

2024. "CBD for Individuals at Risk for Alzheimer's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05822362.

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