Examining the use of Cannabinoid-based Medicine among older residential care recipients diagnosed with dementia: A study protocol for a double blind randomised cross-over trial
Background: Dementia is a neurological condition that affects the cognitive and functional ability of the brain and is the leading cause of disability among those aged 65-years and above. More effective ways to manage dementia symptoms are needed as current treatment options (anti-depressant and antipsychotic) can be ineffective and associated with substantial side-effects, including increased rate of mortality. Cannabinoid-based medicines (CBM) has shown to inhibit some symptoms associated with dementia and the adverse effects are often minimal, yet little research has explored the use of CBM among this population. Aim. To monitor the safety of a purified dose of CBM oil (3:2 THC:CBD) on behaviour symptoms, Quality of life (QOL), and discomfort caused by pain. Methods/Design: We will carry out an 18-week randomised, double-blinded, crossover trial that consists of a 2-week eligibility period, two, 6-week treatment cycles and two, 2-week washout periods (between both cycles, and after the second treatment cycle). We aim to recruit 50 participants with dementia who are living in residential aged-care facilities. The participants will be randomised into two groups, and receive a dose of either CBM oil or placebo for the first treatment cycle and receive the opposite medication for the second. The Neuropsychiatric Inventory Questionnaire, Cohen Mansfield Agitation Inventor, Quality of Life-Alzheimer’s Disease questionnaire, and the Abbey Pain Scale will be collected on seven occasions, and completed by the participants, aged-care staff, and nominated next of kin or family member. The participant’s heart rate and blood pressure will be monitored weekly and their body composition and weight will be monitored fortnightly by a research nurse to assess individual dose response and frailty. In addition, pre- and post-surveys will be administered to aged-care staff and family members to understand their perceptions towards CBM, and to inform proposed focus groups consisting of the aged care staff and next of kin. Discussion: The study design has been informed by medical professionals and key stakeholders including those working in the residential aged-care industry to ensure patient safety, collection of non-invasive measures, and methodological rigor and study feasibility.
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Posted 19 Dec, 2019
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Received 10 Sep, 2019
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On 09 Sep, 2019
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On 16 May, 2019
Examining the use of Cannabinoid-based Medicine among older residential care recipients diagnosed with dementia: A study protocol for a double blind randomised cross-over trial
Posted 19 Dec, 2019
On 14 Feb, 2020
On 18 Jan, 2020
Received 17 Jan, 2020
On 07 Jan, 2020
Invitations sent on 06 Jan, 2020
On 06 Jan, 2020
Received 06 Jan, 2020
On 16 Dec, 2019
On 15 Dec, 2019
Received 13 Dec, 2019
On 13 Dec, 2019
Received 09 Dec, 2019
Received 20 Nov, 2019
On 18 Nov, 2019
Received 14 Nov, 2019
On 12 Nov, 2019
On 12 Nov, 2019
On 08 Nov, 2019
Invitations sent on 08 Nov, 2019
On 08 Nov, 2019
On 07 Nov, 2019
On 12 Oct, 2019
Received 12 Oct, 2019
On 12 Oct, 2019
Received 04 Oct, 2019
Received 10 Sep, 2019
Received 10 Sep, 2019
Received 10 Sep, 2019
On 09 Sep, 2019
Invitations sent on 09 Sep, 2019
On 09 Sep, 2019
On 09 Sep, 2019
On 09 Sep, 2019
On 17 Jul, 2019
On 30 May, 2019
On 16 May, 2019
Background: Dementia is a neurological condition that affects the cognitive and functional ability of the brain and is the leading cause of disability among those aged 65-years and above. More effective ways to manage dementia symptoms are needed as current treatment options (anti-depressant and antipsychotic) can be ineffective and associated with substantial side-effects, including increased rate of mortality. Cannabinoid-based medicines (CBM) has shown to inhibit some symptoms associated with dementia and the adverse effects are often minimal, yet little research has explored the use of CBM among this population. Aim. To monitor the safety of a purified dose of CBM oil (3:2 THC:CBD) on behaviour symptoms, Quality of life (QOL), and discomfort caused by pain. Methods/Design: We will carry out an 18-week randomised, double-blinded, crossover trial that consists of a 2-week eligibility period, two, 6-week treatment cycles and two, 2-week washout periods (between both cycles, and after the second treatment cycle). We aim to recruit 50 participants with dementia who are living in residential aged-care facilities. The participants will be randomised into two groups, and receive a dose of either CBM oil or placebo for the first treatment cycle and receive the opposite medication for the second. The Neuropsychiatric Inventory Questionnaire, Cohen Mansfield Agitation Inventor, Quality of Life-Alzheimer’s Disease questionnaire, and the Abbey Pain Scale will be collected on seven occasions, and completed by the participants, aged-care staff, and nominated next of kin or family member. The participant’s heart rate and blood pressure will be monitored weekly and their body composition and weight will be monitored fortnightly by a research nurse to assess individual dose response and frailty. In addition, pre- and post-surveys will be administered to aged-care staff and family members to understand their perceptions towards CBM, and to inform proposed focus groups consisting of the aged care staff and next of kin. Discussion: The study design has been informed by medical professionals and key stakeholders including those working in the residential aged-care industry to ensure patient safety, collection of non-invasive measures, and methodological rigor and study feasibility.
Figure 1