Status:
UNKNOWN
Effects of THC-Free CBD Oil on Agitation in Patients With Alzheimer's Disease
Lead Sponsor:
Eastern Virginia Medical School
Collaborating Sponsors:
Old Dominion University
Ananda Hemp, Inc.
Conditions:
Alzheimer Disease
Dementia
Eligibility:
All Genders
50-90 years
Phase:
PHASE2
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 participa...
Detailed Description
Individuals with Alzheimer's and other forms of dementia often go through a period of significant behavioral and psychological symptoms of dementia (BPSD). It is estimated that up to 90% of persons wi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04436081
Start Date
February 26 2021
End Date
March 1 2024
Last Update
February 16 2023
Active Locations (1)
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1
Eastern Virginia Medical School
Norfolk, Virginia, United States, 23510