Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
50 – 90
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
40 (estimated)
Sponsor
Eastern Virginia Medical School · Other
Who this trial is looking for
This trial is looking for people over 50 with Alzheimer's-related agitation. Participants will receive CBD oil to see if it helps reduce agitation and improve their quality of life.
Are You a Good Fit for This Trial?
You may be able to join if
I am over 50 years old.
I have been diagnosed with dementia due to Alzheimer's disease.
I scored between 4 and 28 on the Mini-Mental State Exam.
I experience agitation with a specific score greater than 3.
I can read, write, and speak English.
If I take certain medications for cognition, my dosage has been stable for at least a month.
My caregiver has enough contact with me.
You may not be able to join if
I have a different type of dementia.
I scored higher than 28 or lower than 4 on the Mini-Mental State Exam.
I have a score lower than 3 for agitation.
I have a serious medical condition that could affect my safety.
I have any serious psychiatric disorder.
I currently abuse drugs or alcohol.
I have a history of seizures.
I am pregnant or breastfeeding.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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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 subscor…
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.
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