Effects of THC-Free CBD Oil on Agitation in Patients With Alzheimer's Disease (NCT04436081)
🩺 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
Age range: 50 Years to 90 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck 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).
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
📞 Contact the Study Coordinator
Phone: (757) 446-5675
Email: ELKINSDE@evms.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 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.
More studies in Alzheimer Disease
- Automated, Assistive, Non-Contact Sleep Quality Monitor for Individuals With Alzheimer's Disease — Indianapolis, Indiana
- The Use of Memantine for Prevention of Alzheimer's Disease — Charlottesville, Virginia
- Low-Intensity Focused Ultrasound (LIFU) Neuromodulation — Morgantown, West Virginia
- 2-Hydroxybenzylamine (2-HOBA) Study in Early Alzheimer's Patients — Nashville, Tennessee
- [18F]PI-2620 Phase 3 Histopathological Study — Phoenix, Arizona
- A Master Protocol Studying Multiple Amyloid-Targeting Therapies in Healthy Participants and Participants With Alzheimer's Disease — Irvine, California
Explore by condition: All Alzheimer Disease clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.