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THC-Free CBD Oil for Agitation in Alzheimer's Disease

This study is investigating if THC-free CBD Oil (a hemp-based gelcap) can help reduce agitation and aggression in people with Alzheimer's disease and other dementias. It also aims to see if this treatment can lessen the burden on caregivers and improve the participant's quality of life. You might be able to join if you are 50-90 years old, have a diagnosis of dementia with agitation, and a specific score on a memory test (MMSE between 4 and 28) and agitation score (NPI-agitation/aggression subscore > 3). The study is looking for 40 participants. The current status of the study is unclear, so it's not known if they are actively recruiting.

Study design
This is a randomized, double-blinded, placebo-controlled, crossover study involving 40 participants. This means participants will receive either THC-free CBD Oil or a placebo, and neither they nor their doctors will know which one.
What's involved
The study measures changes in agitation, caregiver burden, and quality of life every two weeks or three times over 15 weeks.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 15 weeks during the study enrollment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04436081

Effects of THC-Free CBD Oil on Agitation in Patients With Alzheimer's Disease

Recruiting
PHASE2Ages 50–90InterventionalTreatment
Eastern Virginia Medical School
~40 participants
Updated 2023-02-16 on ClinicalTrials.gov
What's tested:THC-free CBD OilPlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in agitation and aggression.
Measured over Every two weeks for 15 weeks during study enrollment.
+3 more outcomes measured

Conditions

Alzheimer Disease
Dementia
Major Neurocognitive Disorder With Aggressive Behavior

Explore related trials

Alzheimer's DiseaseDementia

Where it's being run

1 sites across 1 states
Virginia1

Study leadership

  • Hamid Okhravi, MD · PRINCIPAL_INVESTIGATOR · Eastern Virginia Medical School

Who to contact

David Elkins, MS
[email protected]
757.446.5675
Email the study team

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Do you actually qualify for this trial?

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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.

What this trial measures

  • Change in agitation and aggression.Every two weeks for 15 weeks during study enrollment.

    Change in agitation and aggression will be measured by the Cohen-Mansfield Agitation Inventory (CMAI), a validated 29-item questionnaire to assess agitation. Each item is rated on a 7-point scale ranging from 1 "Never" to 7 "Several times per hour". Higher scores indicate greater agitation.

  • Change in caregiver burden.Three times during the 15 weeks of study enrollment.

    Change in caregiver burden will be measured by the Zarit Burden Interview (ZBI), a validated 22-item questionnaire to assess caregiver burden. Each item is rated on a 5-point Likert scale that ranges from 0 "Never" to 4 "Nearly always," with the sum of scores ranging between 0-88. Higher scores indicate greater burden.

  • Change in the participant's quality of life.Three times during the 15 weeks of study enrollment.

    Change in the participant's quality of life will be measured by the Quality-of-life assessment in dementia (DEMQOL-proxy), a validated 32-item questionnaire to assess the health related quality of life of people with dementia. Each item is rated on a 4-point scale ranging from 1 "A lot" to 4 "Not at all". Higher scores indicate a healthier quality of life.

  • Change in caregiver's quality of life.Three times during the 15 weeks of study enrollment.

    Change in the caregiver's quality of life will be measured by the Measurement of quality of life in family carers of people with dementia (C-DEMQOL), a validated 30-item questionnaire to assess the quality of life for carers of someone with dementia. Each item is rated on a 5-point scale ranging from 1 "Completely" to 5 "Not at all." Higher scores indicate a healthier quality of life.