Last reviewed · How we verify
Effects of THC-Free CBD Oil on Agitation in Patients With Alzheimer's Disease
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.
Details
| Lead sponsor | Eastern Virginia Medical School |
|---|---|
| Phase | Phase 2 |
| Status | RECRUITING |
| Enrolment | 40 |
| Start date | 2021-02-26 |
| Completion | 2024-03 |
Conditions
- Alzheimer Disease
- Dementia
- Major Neurocognitive Disorder With Aggressive Behavior
Interventions
- THC-free CBD Oil
- Placebo
Primary outcomes
- 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.
Countries
United States