Clinical Pathway for Alzheimer's Disease in China (CPAD): A 8-week Multi-center Registry Study to Investigate AD Diagnostic Pattern in Chinese Local Real Clinical Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,024
- 试验地点
- 28
- 主要终点
- Rate of cognitive assessment administration
研究概览
简要总结
There are guidelines on the management of AD in China, the evidence adopted in the guidelines are mostly from the trials conducted in other countries due to very limited Chinese data available for local systematic review. Therefore, more local evidence on dementia care is needed for the development of an evidence-based guideline appropriate for people living in China. Meanwhile, the inadequate implementation of the current AD guideline, which results in the low diagnostic rate and high diagnostic leakage, may bring about extra barriers for AD patients to access dementia care service in different areas nationwide. However, there is no data on the clinical pathway about how physicians follow the dementia guideline in the routine practice.
Therefore, research is needed to learn clinical diagnostic process and treatment patterns of physicians to people with AD in routine practice and help address the low accurate rate of AD clinical diagnosis and low anti-dementia drug prescription in the real world and support guideline development.
详细描述
Outpatients who are visiting memory clinics and who are judged by physicians with clinically significant cognitive impairment will be invited to join the study during the study recruiting period (with informed consent signed).
- Patients enrolled into the study will be evaluated and diagnosed by participating physicians and may or may not be prescribed with therapy (pharmaceutical and/or non-pharmaceutical) based on physicians' medical judgment.
- For patients with routine clinical follow-up visits, their medical charts will be reviewed for documentation. The procedures of making diagnosis and developing treatment scheme will be retrieved and documented in clinical report form (CRF). Additional procedures ordered by the participating physician at current visits will also be documented in CRF.
All participants will be followed twice after baseline visit to re-evaluate and confirm the initial diagnosis (where applicable), and to record compliance to treatment scheme, including the process of medication titration.
This study does not recommend nor restrict any specific treatments.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female outpatients with clinically significant cognitive impairment per independent judgment of participating physicians;
- •Aged 45 year old and above;
- •Willing to receive 2 follow-up visits;
- •Having at least one informant or caregiver accompanying during each visit;
- •Willing to join the study and sign the informed consent prior to the study.
排除标准
- •Cognitive impairment is likely or identified as secondary to other disease condition(s) than AD (including but not limited to stroke, Parkinson's disease, brain trauma, central nervous system infection, etc.)
- •Unwilling to participate in the study;
- •Participating other studies during the registry study period.
结局指标
主要结局
Rate of cognitive assessment administration
时间窗: 2 months
rate of cognitive assessment administration for diagnosing dementia
次要结局
- Rate of anti-dementia prescription(2 months)
研究者
Huali Wang
Associate Professor
Peking University