RecruitingPhase 2

Effects of THC-Free CBD Oil on Agitation in Patients With Alzheimer's Disease

United States40 participantsStarted 2021-02-26

Plain-language summary

This is a randomized, double-blinded, placebo-controlled, crossover trial that aims to 1) determine the efficacy of THC-free cannabidiol (CBD oil) in reducing the severity of agitation among participants and 2) determine whether THC-free CBD oil can reduce the burden on caregivers and increase the participants' quality of life.

Who can participate

Age range50 Years – 90 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Males/females over 50 years old. * Have a diagnosis of dementia due to AD or mixed AD with another type of dementia. * A Mini-Mental State Exam score (MMSE) between 4 and 28 inclusive. * Presence of agitation with a Neuropsychiatric Inventory (NPI)-agitation/aggression subscore \> 3. * Participants and their informal caregivers must be fluent in English (includes reading, writing, and speech) and able to give informed consent. * For patients treated with cognitive-enhancing medications (cholinesterase inhibitors (ChEI) and/or memantine), the dosage must be stable for at least 1 month (30 days). If the ChEI and/or memantine has been discontinued, patients may enroll after 15 days. * Eligible caregivers must either live with the participant or have a minimum of 4 hours of daily contact with them. Exclusion Criteria: * Diagnosis of non-AD or non-mixed dementias. * Very mild dementia or advanced dementia (MMSE: greater than 28 or less than 4). * NPI-agitation-aggression score \< 3. * Having a serious or unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease which might confound assessment of safety outcomes as determined by the study physician. * Presence or history of other serious psychiatric disorders or neurological conditions (e.g. psychotic disorders, bipolar disorder or schizophrenia). * Current abuse of/dependence on marijuana, current drug abuse, current alcohol abuse. * Having…

What they're measuring

Change in agitation and aggression.

Timeframe: Every two weeks for 15 weeks during study enrollment.

Change in caregiver burden.

Timeframe: Three times during the 15 weeks of study enrollment.

Change in the participant's quality of life.

Timeframe: Three times during the 15 weeks of study enrollment.

Change in caregiver's quality of life.

Timeframe: Three times during the 15 weeks of study enrollment.

Trial details

NCT IDNCT04436081

SponsorEastern Virginia Medical School

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-03

Contact for this trial

David Elkins, MS

757.446.5675 ELKINSDE@evms.edu

View on ClinicalTrials.gov More Alzheimer Disease trials

Plain-language summary

Who can participate

Age range50 Years – 90 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in agitation and aggression.

Timeframe: Every two weeks for 15 weeks during study enrollment.

Change in caregiver burden.

Timeframe: Three times during the 15 weeks of study enrollment.

Change in the participant's quality of life.

Timeframe: Three times during the 15 weeks of study enrollment.

Change in caregiver's quality of life.

Timeframe: Three times during the 15 weeks of study enrollment.