ACTRN12619000474156招募中1 期
Medicinal cannabis and dementia: Effects on behavioural symptoms among older residential care recipients.
niversity of Notre Dame Australia0 个研究点目标入组 50 人开始时间: 2019年3月22日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 65 Years 至 o limit(—)
- 性别
- All
入选标准
- •Live within a residential aged care facility,
- •Aged 65 year or older,
- •Have a diagnosis of dementia, and display at least 3 behavioural symptoms associated with dementia
- •Able to speak English,
- •Known compliance to taking medication, and
- •Not bed ridden.
- •Note those with mild dementia will be able to consent to participant in the study themselves. Those with moderate-to-severe dementia, their next of kin can consent on their behalf if they wish, but will need to speak with an independent medical practitioner prior to their involvement in the study (This is in keeping with the recent changes made to the Western Australian Guardianship and Administration Act of 1990).
排除标准
- •To minimize the likelihood of an adverse event, people with certain health conditions or on some medications will be excluded from the study. These include:
- •-Diagnosed of one or more of the following conditions:
- •-Frontotemporal or Lewy body dementia
- •-Neurodegenerative disease (Epilepsy or recurrent seizure, Anorexia nervosa)
- •-Significant psychiatric disorder other than BPSD associated with underlying condition
- •-Parkinson’s disease
- •-Significant cardiovascular disease (eg arrhythmias, fibrillation, CHF, angina) clinically uncontrolled in the last year Significant cardiovascular disease (eg arrhythmias, fibrillation, CHF, angina) clinically uncontrolled in the last year
- •-History of myocardial infarction with manifestations of active cardiac ischemia in the last year
- •-Clinical event of a stroke within the last 6 months
- •-Significant liver disease or presence of hepatic encephalopathy (where there are grounds to suspect liver disease excluded as per Child-Pugh classification B or C)
- •-Significant renal impairment (where there are grounds to suspect kidney disease excluded as per calculated GFR beneath 60ml/min)
- •-Taking medications that may interact with cannabis metabolism such as Primidone, Phenobarbital, Carbamazepine, Rifampicin, Rifabutin, Troglitazone, Hypericum perforatum, and valproic acid.
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