RecruitingEarly Phase 1NCT04075435

Cannabidiol Solution for the Treatment of Behavioral Symptoms in Older Adults With Mild Cognitive Impairment or Alzheimer's Dementia

Open-Label Trial of a Cannabidiol Solution for the Treatment of Behavioral Symptoms in Older Adults With Mild Cognitive Impairment or Alzheimer's Dementia


Sponsor

Mclean Hospital

Enrollment

12 participants

Start Date

Jan 11, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

This is an open label, eight week, clinical trial of a proprietary high CBD/low THC sublingual solution for the treatment of clinically significant anxiety and agitation in individuals with mild cognitive impairment (MCI) or mild to moderate Alzheimer's Disease (AD).


Eligibility

Min Age: 55 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether cannabidiol (CBD) — a compound derived from cannabis that does not cause a high — can reduce anxiety and behavioral symptoms in older adults with mild cognitive impairment or Alzheimer's disease. **You may be eligible if...** - You are between 55 and 90 years old - You have been diagnosed with probable Alzheimer's disease or mild cognitive impairment (MCI) - You are experiencing clinically significant anxiety or behavioral symptoms - You score between 15 and 30 on the MMSE (a standard memory and thinking test) - You have a caregiver who spends at least 10 hours per week with you and can attend all study visits - You and your caregiver are fluent in English **You may NOT be eligible if...** - You have serious or unstable heart, liver, kidney, lung, or neurological disease that could confound the study - You are currently taking medications that might interact with CBD - Your caregiver is unable to participate in all required visits Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGhigh CBD/low THC sublingual solution

Hemp derived solution to be administered sublingually twice daily.


Locations(1)

McLean Hospital

Belmont, Massachusetts, United States

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NCT04075435


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