THC-free CBD oil to reduce agitation in Alzheimer's disease
Effects of THC-Free CBD Oil on Agitation in Patients With Alzheimer's Disease
This trial will test whether THC-free CBD oil can reduce agitation in people with Alzheimer's disease and related dementias and help reduce caregiver burden.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 50 Years to 90 Years |
| Sex | All |
| Sponsor | Eastern Virginia Medical School Academic / other |
| Locations | 1 site (Norfolk, Virginia) |
| Trial ID | NCT04436081 on ClinicalTrials.gov |
What this trial studies
This is a randomized, double-blind, placebo-controlled, crossover Phase 2 trial comparing THC-free cannabidiol (CBD) oil with placebo in people with Alzheimer's disease or mixed dementia who have clinically significant agitation. Eligible participants are adults over 50 with an MMSE between 4 and 28 and an NPI agitation/aggression subscore greater than 3, and must have an informal caregiver with regular daily contact. The study measures changes in agitation severity, caregiver burden, and participant quality of life across treatment and placebo periods. Participants and caregivers must be fluent in English and able to attend study visits at the lead site.
Who should consider this trial
Good fit: Ideal candidates are people over 50 with a diagnosis of Alzheimer's or mixed Alzheimer's dementia, MMSE 4–28, an NPI agitation/aggression subscore >3, a caregiver with regular daily contact, and stable cognitive-enhancing medications if applicable.
Not a fit: Patients with non-Alzheimer dementias, very mild or very advanced dementia (MMSE >28 or <4), insufficient caregiver contact, or who cannot travel to the site are unlikely to qualify or benefit from this protocol.
Why it matters
Potential benefit: If successful, the intervention could lessen agitation, improve quality of life for patients, and reduce caregiver burden.
How similar studies have performed: A few small studies of cannabinoids for dementia-related symptoms have suggested possible benefit for agitation, but the evidence is limited and remains inconclusive.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Norfolk, Virginia
- Eastern Virginia Medical School — Norfolk, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Hamid Okhravi, MD — Eastern Virginia Medical School
- Study coordinator: David Elkins, MS
- Email: ELKINSDE@evms.edu
- Phone: 757.446.5675
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.