NCT04436081 Effects of THC-Free CBD Oil on Agitation in Patients With Alzheimer's Disease
| NCT ID | NCT04436081 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Eastern Virginia Medical School |
| Condition | Alzheimer Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2021-02-26 |
| Primary Completion | 2024-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 40 participants in total. It began in 2021-02-26 with a primary completion date of 2024-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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 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. * Changes in dosage of anti-depressives within 4 weeks before randomization and during the study. * Changes in dosage of antipsychotics or benzodiazepines within 1 week prior to randomization and during the study. * Contraindications to CBD oil (history of hypersensitivity to any cannabinoid). * Frequent falling due to orthostatic hypotension. * Use of tricyclic antidepressants (TCA), fluoxetine, and/or carbamazepine. -Patients who reside in nursing homes.
Contact & Investigator
Hamid Okhravi, MD
PRINCIPAL INVESTIGATOR
Eastern Virginia Medical School
Frequently Asked Questions
Who can join the NCT04436081 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 90 Years, studying Alzheimer Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04436081 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04436081 currently recruiting?
Yes, NCT04436081 is actively recruiting participants. Contact the research team at ELKINSDE@evms.edu for enrollment information.
Where is the NCT04436081 trial being conducted?
This trial is being conducted at Norfolk, United States.
Who is sponsoring the NCT04436081 clinical trial?
NCT04436081 is sponsored by Eastern Virginia Medical School. The principal investigator is Hamid Okhravi, MD at Eastern Virginia Medical School. The trial plans to enroll 40 participants.
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