Actively Recruiting
Effects of THC-Free CBD Oil on Agitation in Patients With Alzheimer's Disease
Led by Eastern Virginia Medical School · Updated on 2023-02-16
40
Participants Needed
1
Research Sites
157 weeks
Total Duration
On this page
Sponsors
E
Eastern Virginia Medical School
Lead Sponsor
O
Old Dominion University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effects of THC-Free CBD Oil on Agitation in Patients With Alzheimer's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged over 50 years
- Diagnosed with dementia due to Alzheimer's disease or mixed Alzheimer's with another dementia
- Mini-Mental State Exam (MMSE) score between 4 and 28 inclusive
- Agitation with a Neuropsychiatric Inventory (NPI) agitation/aggression subscore greater than 3
- Participants and informal caregivers fluent in English and able to give informed consent
- Stable dose of cognitive-enhancing medications for at least 30 days or 15 days after discontinuation
- Caregivers living with the participant or having at least 4 hours of daily contact
You will not qualify if you...
- Diagnosis of non-Alzheimer's or non-mixed dementias
- Very mild dementia or advanced dementia (MMSE score less than 4 or greater than 28)
- NPI agitation/aggression score less than or equal to 3
- Serious or unstable medical illnesses that could affect safety assessments
- History or presence of serious psychiatric or neurological disorders such as psychotic disorders, bipolar disorder, or schizophrenia
- Current abuse or dependence on marijuana, drugs, or alcohol
- Seizure disorders
- Pregnant or breastfeeding individuals
- Baseline delirium as per Confusion Assessment Method
- Current use of lithium
- Inability to swallow CBD oil softgels
- Recent changes in antidepressant, antipsychotic, or benzodiazepine dosages
- Hypersensitivity to cannabinoids
- Frequent falls due to orthostatic hypotension
- Use of tricyclic antidepressants, fluoxetine, or carbamazepine
- Residence in nursing homes
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Eastern Virginia Medical School
Norfolk, Virginia, United States, 23510
Actively Recruiting
Research Team
D
David Elkins, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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