ISRCTN02733714已完成不适用
Alzheimer?s Drug Duration - Impact on Functionality: a pragmatic trial of continuing, stopping or switching cholinesterase inhibitors among patients with indeterminate response
British Columbia Ministry of Health Services (Canada)0 个研究点目标入组 1,000 人开始时间: 2008年10月21日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Policy criteria:
- •The patient is approved at least once for insurance coverage of ChEIs by British Columbia PharmaCare (the publicly financed drug benefit plan), meaning:
- •1.1. They are residents of British Columbia eligible for PharmaCare coverage
- •1.2. They are not in a hospital or long-term care institution (because drugs of such patients are mostly covered by the Health Authorities)
- •1.3. A physician has reported on a Special-Authority Request (insurance coverage application) form that the patient has a diagnosis involving Alzheimer's disease, and the severity of dementia was mild-to-moderate (scoring greater than 10 but less than 26 on the Standardised Mini-Mental Status Examination [SMMSE]) when they were first covered by PharmaCare
- •2. Clinical criteria:
- •At enrolment:
- •2.1. The patient has taken ChEIs for no longer than 12 months and has not used them for at least 12 months prior to that 12 months
- •2.2. The patient has tolerated ChEIs for at least 5 months but may have switched within that time due to intolerance of one type of ChEI
- •2.3. A physician has reported on a Special-Authority Request (insurance coverage application) form that the patient's Overall Patient Assessment Rating (OPAR), including assessments of cognition, function and behaviour, has neither improved nor seriously declined (i.e. 'indeterminate response', which means the difference in OPAR score is 0 or -1) by 6 to 12 months after starting the medications
- •2.4. Males and females included with no set age
- •3. Social-logistical criteria:
- •The personal caregiver (e.g. spouse or guardian) must be informed and consent as well as the patient. Therefore, the patient and caregiver:
- •3.1. Must speak English
- •3.2. Must be available by telephone
- •3.3. Must be willing to communicate by telephone with the Centre on Ageing. The patient's physician must also agree to their prescribing decisions being directed by a study protocol.
排除标准
- •1. Non-Alzheimer-related dementia (for Special-Authority coverage, the diagnosis must be Alzheimer's disease, Alzheimer's disease with a vascular component, Alzheimer's disease with Lewy bodies or mixed dementia with predominant Alzheimer's disease)
- •2. Delay in recruitment of patients or their follow-up visit to their physician, so that they have taken ChEIs continuously for longer than 12 months prior to their availability to be randomised
- •3. Any use of ChEIs, even if brief, during the 12 months prior to the patient's most recent start of continuous use. However, patients who have used and stopped ChEIs more than 12 months before their most recent start of continuous use may be included.
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