Who is eligible for clinical trial NCT04436081?

Participants must meet protocol criteria for Alzheimer Disease. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT04436081 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2023-02-15

Effects of THC-Free CBD Oil on Agitation in Patients With Alzheimer's Disease (NCT04436081)

🟢 Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Eastern Virginia Medical School

🩺 Plain-English Summary (8th-Grade Level)

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 join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (17 items).

Location: Eastern Virginia Medical School — Norfolk, Virginia

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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.

Usually NOT eligible if any of the following apply:

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 seizure disorders.
Pregnant or breastfeeding
Indication of baseline delirium as determined by the Confusion Assessment Method (CAM).
Current use of lithium.
Inability to swallow CBD oil softgels.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

Eastern Virginia Medical School — Norfolk, Virginia

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗