NCT04436081RecruitingPhase 2
Effects of THC-Free CBD Oil on Agitation in Patients With Alzheimer's Disease
Source: ClinicalTrials.gov · Last updated 16 Feb 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 12 Jun 2020
- Start date
- 26 Feb 2021
- Primary completion date
- 31 Mar 2024
- Lead sponsor
- Eastern Virginia Medical School
- Diseases
- Alzheimer disease
- NCT number
- NCT04436081
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 40
- From 26 Feb 2021 to the primary completion date, 31 Mar 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current abuse of/dependence on marijuana, current drug abuse, current alcohol abuse.
- 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.
Other illness
- Very mild dementia or advanced dementia (MMSE: greater than 28 or less than 4).
- 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).
- Having seizure disorders.
- Contraindications to CBD oil (history of hypersensitivity to any cannabinoid).
Other
- Diagnosis of non-AD or non-mixed dementias.
- NPI-agitation-aggression score \< 3.
- 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.
- Frequent falling due to orthostatic hypotension.
- Use of tricyclic antidepressants (TCA), fluoxetine, and/or carbamazepine. -Patients who reside in nursing homes.
Who the study is looking for
- 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.
Age in the registry: 50 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Eastern Virginia Medical School Coordinator of this site? Confirm its status | Norfolk | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.