Medicinal cannabis use among dementia patients

INTERVENTION: This study is a parallel mixed methods design that includes a randomised, double blinded, crossover, N‐of‐1, placebo‐control trial. This is similar to a phase II randomised control trial: Arm 1: Placebo Arm 2: Medicinal Cannabis oil This trial will run for 16 weeks. In a crossover design a number of treatment cycles occur where each participant will receive the placebo and the medicinal cannabis oil during one treatment cycle. This trial will include two, six‐week treatment cycles. For the first six week treatment cycle, participants will be randomised into the placebo group (Arm 1) or medicinal cannabis oil (Arm 2) group. After the first six week treatment cycle, a two‐week washout period will occur. During the second treatment cycle those who took the medicinal cannabis oil (Arm 2) in the first treatment cycle will take the placebo (Arm 1) during the second treatment cycle and vis versa. After the second treatment cycle, an additional two‐week washout period will occur to monitor the participants as they will no longer be taking any additional medication. The 16 week will comprise of two, six‐week treatment cycles, with a two, two‐week wash out periods. The mode of administration will be through an oral spray. The dose, will be increased from 2.5mg/day (1 spray) until the participant reaches their best, tolerated dose or a maximum of 50mg/day (20 sprays). The dose will be increased approximately every three days and on the days the dose has been increased, the resident will record the presence of any adverse events one hour after the dose has been administered. Following the recording of any moderate to severe adverse events (determined as ‘Somewhat worse’ [moderate] or ‘Much worse’ [severe] on the participants adverse event record) that has not ameliorated by the time for the next dose, the participant will receive the previous, best tolerated dose. If the effects of the adverse event(s) have disappeared or become CONDITION: Dementia; ; Dementia Neurological ‐ Dementias SECONDARY OUTCOME: Adverse events will be monitored by the participants each time they receive a higher dose of medication. If moderate to severe adverse events are recorded [determined as ‘Somewhat worse’ (moderate) or ‘Much worse’ (severe) on the participants adverse event record] and these events have not ameliorated by the time for the next dose, the participant will use the previous, best tolerated dose, or if the effects of the adverse event(s) have disappeared or become milder, and do not interfere with the participant’s daily function or well‐being, the caregivers may increase their dose at the indicated rate. For example, some adverse events may include, drowsiness, dizziness, dry mouth, lured vision).[This will be measured each time the dose of medication is increased (approximately every three days). (day 1, 3, 6, 9, 12, 15, 18, 21, 24, 27... etc...).] Focus groups with the primary carers and the family members will be used to assess their perceptions before and after the use of medicinal cannabis and will be used to gather more in‐depth information from the pre and post surveys. [Completed after the last dose is administered in the second treatment arm (Day 98)] post surveys will be completed by the primary carer and family members to assess their perceptions towards medicinal cannabis at the after of the treatment. These surveys have been designed specifically for this study.[This will be completed after the last dose of medication has been administered in the second treatment arm. (Day 98)] pre surveys will be completed by the primary carer and family members to assess their perceptions towards medicinal cannabis before the medication is being administered. These surveys have been designed specifically for this study.[This will be completed before the first dose of medication is administered (Days 0)] Quality of life Alzheimer’s disease (QOL‐AD; Logsdon, Gibbons, McCurry, & Teri, 2002) will be used to identify if any changes in QOL occur. The QOL‐AD consists of 13‐items,using a 4‐point Likert scale [poor (1), fair (2), good (3) and excellent (4)] and is designed for both self and proxy report. An overall total QOL score is derived, with a higher score indicating a higher QOL[The QOL‐AD will be collected at seven time points throughout the study at the same time as the NPI‐NH. This will be completed three times during the first treatment arm [baseline (Day 0), after maximum tolerated dose has been reached (Day 24), at the end of the treatment cycle (Day 42)], three times during the second treatment arm [baseline (Day 56), After maximum tolerated dose has been reached (Day 80), End of the treatment cycle (Day 97)] and once following the two‐week washout period after the second treatment arm (Day 112). ] The Abbey Pain Assessment Scale (APAS; Abbey et al., 2004) will be used to assess the participants level of pain. The APAS assesses pain by examining vocalization, facial expression, change in body language, behavioural change, physiological change, and physical change. This questionnaire uses a 4‐point Likert scale [Absent (0), Mild (1), Moderate (2), Severe (3)] and a total score of 18 is calculated. The severity of pain is indicated as mild (3‐7), moderate (8‐13) and severe (14+). [The APAS will be collected at seven time points throughout the study at the same time as the NPI‐NH. This will be completed three times during the first treatment arm [baseline (Day 0), after maximum tolerated dose has been reached (Day 24), at the end of the treatment cycle (Day 42)], three times during the second treatment arm [baseline (Day 56), After maximum tolerated dose has been reached (Day 80), End of the treatment cycle (Day 97)] and once following the two‐week washout period after the second treatment arm (Day 112). ] The Cohen‐Mansfield Agitation Inventory‐ Community (CMAI‐C; Cohen‐Mansfield, 1996) will be collected to assess behavioral changes. The CMAI‐C is a 29 item questionnaire and examines three behavioral factors (aggressive behaviour, physically nonaggressive behaviour and verbally agitated behavior). A total score is calculated, from a 7‐point Likert scale [Never (1), Less than once a week (2), Once or twice a week (3), Several times a week (4), Once or twice a day (5), Several times a day (6), Several times an hour (7)] with a higher score indicating greater changes in behavior.[The CMAI‐C will be collected at seven time points throughout the study at the same time as the NPI‐NH. This will be completed three times during the first treatment arm [baseline (Day 0), after maximum tolerated dose has been reached (Day 24), at the end of the treatment cycle (Day 42)], three times during the second treatment arm [baseline (Day 56), After maximum tolerated dose has been reached (Day 80), End of the treatment cycle (Day 97)] and once following the two‐week washout period after the second treatment arm (Day 112). ] The participants blood pressure will be monitored by a research nurse using a blood pressure cuff and stethoscope.[twice a week during both treatment cycles (approximate every Monday and Thursday)] The participants body composition (using a scale) to measure lean body mass, bone mass and fat mass.[This will be measured once a week (approximately every Monday).] The participants heart rate will be monitored by a research nurse using a stethoscope. [The participants heart rate and blood pressure will be monitored twice a week and their weight and non‐invasive body composition measure will be taken once a week by a research nurse. Adverse events will be reported one hour after the dose of the medication has been increased. ] The participants weight will be monitored by a research nurse using a scale.[measured once a week (approximately every Monday)] INCLUSION CRITERIA: • Live within a residential aged care facility, • Aged 65 year or older, • Have a diagnosis of dementia, • Able to speak English, • Known compliance to taking medication, and • Not bed ridden. PRIMARY OUTCOME: The Neuropsychiatric Inventory Questionnaire‐Nursing Homes (NPI‐NH; Cummings et al., 1997) measures 12 neuropsychiatric symptoms (delusions, hallucinations, agitation, depression, anxiety, euphoria/ elation, apathy/ indifference, disinhibition, irritability, aberrant motor behaviour, night time disturbances and appetite changes). The primary outcome will derived from the total score of all 12 domain scores to examine the total number of behavioural symptoms. The higher the score, the greater the presence of behavioural symptoms present. [The NPI‐NH will be collected at seven time points throughout the study. This will be completed three times during the first treatment arm [baseline (Day 0), after maximum tolerated dose has been reached (Day 24), at the end of the treatment cycle (Day 42)], three times during the second treatment arm [baseline (Day 56), After maximum tolerated dose has been reached (Day 80), End of the treatment cycle (Day 97)] and once following the two‐week washout period after the second treatment arm (Day 112). ]