Prospective Research in Memory Clinics (PRIME)
2013年11月28日 更新者：Janssen-Cilag Pty Ltd
The purpose of the PRIME Study is to examine the current management and outcomes of patients with mild cognitive impairment or dementia.
Approximately 4500 patients will be enrolled in this disease registry across 12 sites in Australia.
Clinical, treatment, health status and economic data will be acquired over 3 years.
The study will identify the relationships among demographic variables, prognostic features, geographic setting, treatment options and clinical, economic and health status (activities of daily living and caregiver impact) outcomes.
研究概览
详细说明
A complete record of patient care will be collected to provide detailed information on the management and outcome of mild cognitive impairment and dementia and the profile of patients at participating sites.
The data will be used to build models looking at the effect of management of these conditions on principal clinical events, health status and economic outcomes.
This will provide the foundation for subsequent objective and prospective evaluation of evidence-based strategies for the optimal treatment of mild cognitive impairment and dementia in Australia.
This study is not prescriptive, but will instead examine the influence of a whole range of routinely used management strategies on clinical and economic outcomes among mild cognitive impaired and dementia patients in Australia.
This 'practice based' approach is increasingly widely used and is a useful tool for elucidating the relative effectiveness of different management strategies and for exploring relationships between patient characteristics, treatment and outcomes.
Observational study - no study drug administered.
研究类型
观察性的
注册 (实际的)
970
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Chermside N/A、澳大利亚
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Fremantle、澳大利亚
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Geelong、澳大利亚
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Heidelberg、澳大利亚
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Hornsby、澳大利亚
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Kew、澳大利亚
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Newcastle、澳大利亚
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Randwick、澳大利亚
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Woodville、澳大利亚
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Consenting patients with mild cognitrive impairement or dementia recruited at 12 participating sites accross Australia.
描述
Inclusion Criteria:
- Diagnosis of dementia under the DSM-IV criteria, or of Mild Cognitive Impairment, using the Peterson Criteria
- Living in the community (home, apartment or collective housing with nursing care available for less than 40 hours per week)
- Patient able to provide written informed consent, or provision of written informed consent by a legal guardian/proxy
- Availability of a caregiver willing to provide consent for required components of the study
- Fluent in English
- May be participating in a Phase IV or other post-marketing follow up study of an approved product for treatment of dementia
Exclusion Criteria:
- No concomitant life-threatening illness (a condition which is likely to interfere with the patient's ability to complete the study)
- Not unwilling or unable to complete the study
- Not concurrently participating in a clinical trial of an investigational drug (phase I, II or III)
- Unwillingness of patient or legal guardian / proxy to provide written informed consent
- Unwillingness of caregiver to provide written informed consent
- For patients with diagnosis of mild cognitive impairment: current or previous treatment with any cholinesterase or memantine
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 观测模型：队列
- 时间观点：预期
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Mild cognitive impairment or dementia
Patients with mild cognitive impairment or dementia.
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Patients will be observed for the evaluation of current management strategies.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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The primary objective of the study is to analyse the epidemiology and treatment outcomes of mild cognitive impairment and dementia under conditions of routine clinical practice
大体时间：6 months, 12 months and 36 months
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6 months, 12 months and 36 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change From Baseline in Clinical Dementia Rating Scale (total and overall score)
大体时间：Baseline, 3, 6, 12, 24, and 36 months
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CDR is a 5-point scale to evaluates the clinical patterns and severity of the patients suspected or diagnosed as dementia in 6 areas: memory, orientation, judgment and problem solving ability, social activity, domestic living and hobbies, and hygiene and dressing up, where 0 = no cognitive impairment, 0.5 = very mild dementia, 1 = mild, 2 = moderate, and 3 = severe.
Higher scores indicate worsening.
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Baseline, 3, 6, 12, 24, and 36 months
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Mini Mental State Examination (total score)
大体时间：Baseline, 3, 6, 12, 24 and 36 months
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The mini-mental state examination (MMSE) is a brief 30-point questionnaire test that is used or the assessment of dementia patients' cognitive impairment.
Evaluation of points are as follows: 24 to 30 = no cognitive impairment, 18 to 23 = mild cognitive impairment, 0 to 17 = severe cognitive impairment.
Lower scores indicate worsening.
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Baseline, 3, 6, 12, 24 and 36 months
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The Alzheimer's Disease Assessment Scale (cognitive total score)
大体时间：Baseline, 3, 6, 12, 24 and 36 months
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Alzheimer's Disease Assessment Scale is consists of 11 items, which assess memory, language and praxis, and can be administered independently of the non-cognitive portion.
The total score ranges between 0 (best) and 70 (worst), with eight of the eleven items scoring between 0 (no impairment) and 5 (most impairment), and three of the items scoring from 0 to 8 (orientation questions), 0 to 10 (word recall) and 0 to 12 (word recognition).
Higher scores indicate worsening
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Baseline, 3, 6, 12, 24 and 36 months
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The Clock Drawing Test (total score)
大体时间：Baseline, 3, 6, 12, 24 and 36 months
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The Clock Drawing Test is a simple and reliable measure of visuospatial ability.
The test requires the participant to draw the face of a clock reading ten minutes after eleven, and the rater scores the result from 10 (best) to 1 (worst).
Lower scores indicate worsening.
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Baseline, 3, 6, 12, 24 and 36 months
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Frontal Assessment Battery (total score)
大体时间：Baseline, 3, 6, 12, 24 and 36 months
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Frontal Assessment Battery is a short, simple testing for frontal lobe function that explores six domains of frontal lobe activity; conceptualization, mental flexibility, motor programming, sensitivity to interference, inhibitory control, and environmental autonomy.
It takes approximately 10 minutes to administer.
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Baseline, 3, 6, 12, 24 and 36 months
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Functional Autonomy Measurement System (total score and subscores)
大体时间：Baseline, 3, 6, 12, 24 and 36 months
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Functional Autonomy Measurement System is a 29-item scale developed according to the WHO classification of disabilities.
It measures functional ability in five areas: activities of daily living (ADL), mobility, communication, mental functions and instrumental activities of daily living (IADL).
For each item, the disability is scored on a 5-point scale: 0 (independent), -0.5 (with difficulty), -1 (needs supervision), -2 (needs help), -3 (dependent).
A disability score (up to -87) can be calculated, together with sub-scores for each dimension.
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Baseline, 3, 6, 12, 24 and 36 months
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Neuropsychiatric Inventory (total score, total distress to caregivers score, and total number of behaviors)
大体时间：Baseline, 3, 6, 12, 24 and 36 months
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The neuropsychiatric inventory is used to characterize the neuropsychiatric symptom profiles in a variety of neurological diseases.
Categories include symptoms like delusions, hallucinations, dysphoria, anxiety, agitation/aggression, euphoria, disinhibition, irritability, apathy, Night-time behaviour, appetite and eating, and aberrant motor activity.
For each symptom, responder has to indicate "yes", if the symptom has been present since a month.
The responder then rate the severity of the symptom on a 3-point scale for which scores range from "1 = Mild (noticeable, but not a significant change)" to "3 = Severe (very marked or prominent; a dramatic change)" and also rate the distress experienced due to the symptom on a 6-point scale for which scores range from "0 = Not distressing at all" to "5 = Extreme or very severe (extremely distressing, unable to cope with)".
Higher scores indicate more behavioural disturbance.
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Baseline, 3, 6, 12, 24 and 36 months
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Zarit caregiver burden interview (total score)
大体时间：Baseline, 3, 6, 12, 24 and 36 months
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Zarit caregiver burden scale is used to measure caregiver burden as it relates to time, developmental comparison with peers, physical health, social relationships, and emotional health.
It has 22 item and each question is scored on a 5-point Likert scale ranging from 0 = never present to 4 = nearly always present.
The sum of the total scores of the 22-items is calculated in the range from 0 (low burden) to 88 (high burden).
Higher scores indicate worsening.
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Baseline, 3, 6, 12, 24 and 36 months
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Resource Utilization
大体时间：Every month up to 36 months
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Resource utilization questionnaire will be completed at the end of each calendar month by participant/caregiver.
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Every month up to 36 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2005年8月1日
初级完成 (实际的)
2011年8月1日
研究完成 (实际的)
2011年8月1日
研究注册日期
首次提交
2006年2月24日
首先提交符合 QC 标准的
2006年2月24日
首次发布 (估计)
2006年2月28日
研究记录更新
最后更新发布 (估计)
2013年12月2日
上次提交的符合 QC 标准的更新
2013年11月28日
最后验证
2013年11月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.