Alzheimer Disease Clinical Trial
Official title:
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | March 2024 |
Est. primary completion date | March 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years to 90 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Eastern Virginia Medical School | Norfolk | Virginia |
Lead Sponsor | Collaborator |
---|---|
Eastern Virginia Medical School | Ananda Hemp, Inc., Old Dominion University |
United States,
Cerejeira J, Lagarto L, Mukaetova-Ladinska EB. Behavioral and psychological symptoms of dementia. Front Neurol. 2012 May 7;3:73. doi: 10.3389/fneur.2012.00073. eCollection 2012. — View Citation
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Cummings J, Lee G, Ritter A, Zhong K. Alzheimer's disease drug development pipeline: 2018. Alzheimers Dement (N Y). 2018 May 3;4:195-214. doi: 10.1016/j.trci.2018.03.009. eCollection 2018. — View Citation
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Kales HC, Gitlin LN, Lyketsos CG. Assessment and management of behavioral and psychological symptoms of dementia. BMJ. 2015 Mar 2;350:h369. doi: 10.1136/bmj.h369. — View Citation
Khan SS, Ye B, Taati B, Mihailidis A. Detecting agitation and aggression in people with dementia using sensors-A systematic review. Alzheimers Dement. 2018 Jun;14(6):824-832. doi: 10.1016/j.jalz.2018.02.004. Epub 2018 Mar 20. — View Citation
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* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Every two weeks for 15 weeks during study enrollment. | |
Primary | 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. | Three times during the 15 weeks of study enrollment. | |
Primary | 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. | Three times during the 15 weeks of study enrollment. | |
Primary | 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. | Three times during the 15 weeks of study enrollment. | |
Secondary | 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". | Three times during the 15 weeks of study enrollment. | |
Secondary | 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. | Three times during the 15 weeks of study enrollment. | |
Secondary | 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. | Measured on a daily basis during the 15 weeks of study enrollment. |
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