Effects of THC-Free CBD Oil on Agitation in Patients With Alzheimer's Disease
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|ClinicalTrials.gov Identifier: NCT04436081|
Recruitment Status : Recruiting
First Posted : June 17, 2020
Last Update Posted : May 4, 2022
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer Disease Dementia Major Neurocognitive Disorder With Aggressive Behavior||Drug: THC-free CBD Oil Drug: Placebo||Phase 2|
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 with dementia (PWD) experience behavior problems at some point. BPSDs can be challenging for both unpaid family caregivers as well as paid caregivers. Family caregivers provide the bulk of care for PWD and number over 15 million. One of the most common types of BPSDs is agitation with a prevalence of up to 87%, based on a recent systematic review. Agitation can lead to impaired daily functioning, prolongation of hospitalization, reduced time to institutionalization, and is associated with higher mortality. Additionally, agitated behavior is associated with increased injury to both patients and caregivers. Based on the 2018 Alzheimer's disease drug development pipeline report almost 70% of clinical trials related to BPSD are dedicated to agitation behavior. Finding ways to address agitation is necessary to improve overall quality of life for PWD and their caregivers. Currently, there are no medications available specifically for the treatment of BPSDs. The use of benzodiazepines, antipsychotics and mood stabilizing agents are common, but the risks and side effects often outweigh any benefits.
Several small studies have investigated the use of cannabinoids in the treatment of pathology and symptomology of Alzheimer's disease (AD), as well as treatment of the agitation component of BPSD. A handful of these studies showed that the symptoms of BPSD were decreased with the use of cannabinoids. However, due to small sample sizes, study design, and short trial duration of these studies, the efficacy of these agents on BPSD cannot be confirmed. In addition, cannabinoids have demonstrated anti-oxidant and anti-inflammatory effects, and both processes have been indicated as major contributors to the neurologic effects of AD. Some evidence exists that agitation is related to this neuroinflammatory process. This study will examine the effects of cannabinoids on the behavioral and psychological symptoms of individuals with a dementia diagnosis.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Effects of THC-Free CBD Oil on Agitation in Patients With Alzheimer's Disease|
|Actual Study Start Date :||February 26, 2021|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||February 2023|
Active Comparator: Hemp-based CBD oil Gelcaps
The intervention consists of 6 weeks oral administration of CBD oil Gelcaps, starting at a dosage of 15 mg twice per day with up titration to 45 mg twice per day. At any given dose, if participants develop side effects, the dosage will be reduced to the previous dose.
Drug: THC-free CBD Oil
Hemp-based CBD oil Gelcaps
Placebo Comparator: Oral placebo Gelcaps
Participants in the control group will receive oral placebo Gelcaps that are identical in appearance to the CBD oil Gelcaps. Dosing will be identical to the intervention arm.
- Change in agitation and aggression. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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.
- Assessment of change in neuropsychiatric symptoms. [ Time Frame: Three times during the 15 weeks of study enrollment. ]Assessment of change in neuropsychiatric symptoms for the participant will be measured by the Neuropsychiatric Inventory (NPI), a validated questionnaire that assesses dementia-related behavioral symptoms. The NPI examines 12 sub-domains of behavioral functioning. Each sub-domain is rated on the frequency of the symptoms using a 4-point scale with 1 "Occasionally" and 4 "Very frequently", the severity of the symptoms using a 3-point scale with 1 "Mild" and 3 "Marked", and the distress the symptom causes them on a 5-point scale with 1 "Not at all" and 5 "Very severely or extremely".
- Assessment of change in cognitive skills. [ Time Frame: Three times during the 15 weeks of study enrollment. ]Assessment of change in cognitive skills for the participant will be measured by the Mini Mental State Exam (MMSE), a validated 30-item questionnaire used to measure cognitive impairment among the elderly. A 30-item, clinician-administered assessment of orientation, attention, calculation, learning and memory, language, and visuospatial skills. Each correct response is summed to produce a total score out of 30 possible points.
- The effect of CBD oil on sleep quantity measured by Fitbit [ Time Frame: Measured on a daily basis during the 15 weeks of study enrollment. ]The effect of CBD oil on sleep quality will be measured for the participant and caregiver using the actigraphy function of fit bit. These measures include the amount of total sleep, amount of rapid eye movement (REM) sleep and the amount of deep and light sleep.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04436081
|Contact: David Elkins, MS||757.446.5675||ELKINSDE@evms.edu|
|United States, Virginia|
|Eastern Virginia Medical School||Recruiting|
|Norfolk, Virginia, United States, 23510|
|Contact: Hamid Okhravi, MD 757-446-7040 okhravHR@evms.edu|
|Principal Investigator: Hamid Okhravi, MD|
|Principal Investigator:||Hamid Okhravi, MD||Eastern Virginia Medical School|