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. 2020 Feb 14;21(1):188.
doi: 10.1186/s13063-020-4085-x.

Use of cannabinoid-based medicine among older residential care recipients diagnosed with dementia: study protocol for a double-blind randomised crossover trial

Amanda Timler  1 , Caroline Bulsara  2 , Max Bulsara  2 , Alistair Vickery  3 , Jill Smith  2 , Jim Codde  2
Affiliations

Use of cannabinoid-based medicine among older residential care recipients diagnosed with dementia: study protocol for a double-blind randomised crossover trial

Amanda Timler et al. Trials. .

Abstract

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 because current treatment options (antidepressants and antipsychotics) can be ineffective and are associated with substantial side effects, including increased rate of mortality. Cannabinoid-based medicine (CBM) has shown an ability 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 delta-9-tetrahydrocannabinol:cannabidiol) on behaviour symptoms, quality of life and discomfort caused by pain.

Methods/design: We will carry out an 18-week, randomised, double-blind 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 will receive a dose of either CBM oil or placebo for the first treatment cycle and the opposite medication for the second. Data will be collected using the Neuropsychiatric Inventory Questionnaire, the Cohen-Mansfield Agitation Inventory, the Quality of Life in Alzheimer's Disease questionnaire, and the Abbey Pain Scale on seven occasions. These will be completed by the participants, aged-care staff, and nominated next of kin or family members. The participants' 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 of 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.

Trial registration: Australian New Zealand Clinical Trials Registry, ACTRN12619000474156. Registered on 21 March 2019.

Keywords: Behavioural and neuropsychiatric symptoms of dementia (BPSD); Crossover trial; Dementia; Medicinal cannabis; Pain; Quality of life.

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Conflict of interest statement

The authors declare that there may be a perceived conflict of interest in undertaking research funded by MGC Pharmaceuticals, the manufacturer of the drug used in the trial; a number of precautionary steps have been implemented to minimise these. These steps include input on study design and drug doses obtained in the development of the research protocol and securing TGA approval for provision of the drug. All MGC Pharmaceuticals staff will be excluded from the trial itself, including the data collection as well as analysis and interpretation of the data. In joint management meetings, the progress of the study will only be discussed in broad terms to ensure compliance with budgetary issues and appropriate responses to any serious adverse events. UNDA has written permission from MGC Pharmaceuticals Ltd. for a worldwide, non-exclusive, royalty-free license to use the project intellectual property for non-commercial research purposes, including consent to publish research findings regardless of the results. The results will be disseminated via brief reports provided to the participating aged care facilities, as well as through manuscript publications and conference presentations.

Figures

Fig. 1
Fig. 1
The key phases of the 18-week trial
See this image and copyright information in PMC

References

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