Effects of THC-Free CBD Oil on Agitation in Patients With Alzheimer's Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age50-90
SponsorEastern Virginia Medical School
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Crossover
Treatments tested in this trial
THC-free CBD Oil
DrugHemp-based CBD oil Gelcaps
Placebo
DrugPlacebo Gelcaps
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Hemp-based CBD oil GelcapsActive comparator 1 intervention
Group B: Oral placebo GelcapsPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in agitation and aggression.
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.
Time frame
Every two weeks for 15 weeks during study enrollment.2
Change in caregiver burden.
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.
Time frame
Three times during the 15 weeks of study enrollment.3
Change in the participant's quality of life.
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.
Time frame
Three times during the 15 weeks of study enrollment.4
Change in caregiver's quality of life.
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.
Time frame
Three times during the 15 weeks of study enrollment.Secondary outcomes
1
Assessment of change in neuropsychiatric symptoms.
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".
Time frame
Three times during the 15 weeks of study enrollment.2
Assessment of change in cognitive skills.
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.
Time frame
Three times during the 15 weeks of study enrollment.3
The effect of CBD oil on sleep quantity measured by Fitbit
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.
Time frame
Measured on a daily basis during the 15 weeks of study enrollment.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Eastern Virginia Medical School
Lead sponsor
Old Dominion University
Collaborator
Ananda Hemp, Inc.
Collaborator
Source ClinicalTrials.gov