Clinical Pathway for Alzheimer's Disease in China (CPAD)

Completed

• Conditions: Alzheimer's Disease; Mild Cognitive Impairment; Dementia

• Registration Number: NCT01779310
• Lead Sponsor: Peking University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2013-01-24
• Study First Submitted QC: 2013-01-29
• Study First Posted: 2013-01-30
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-22
• Last Update Posted: 2017-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1024

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of cognitive assessment administration	2 months	rate of cognitive assessment administration for diagnosing dementia

Secondary Outcome Measures

Name	Time	Method
Rate of anti-dementia prescription	2 months	rate of anti-dementia prescription for people with dementia

Trial Locations

Locations (28)

The Second Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China

Nanjing Brain Hospital; 🇨🇳 Nanjing, Jiangsu, China

First Affiliated Hospital of Medical College of Xi'an Jiaotong University; 🇨🇳 Xi'an, Shaanxi, China

Shandong Mental Health Center; 🇨🇳 Jinan, Shandong, China

Shandong Provincial Hospital; 🇨🇳 Jinan, Shandong, China

Mental Health Center, West China Hospital, Sichuan University; 🇨🇳 Chengdu, Sichuan, China

General Hospital, Tianjin Medical University; 🇨🇳 Tianjin, Tianjin, China

Guangzhou Brain Hospital; 🇨🇳 Guangzhou, Guangdong, China

The First Hospital of Hebei Medical University; 🇨🇳 Shijiazhuang, Hebei, China

The First Affiliated Hospital of Anhui Medical University; 🇨🇳 Hefei, Anhui, China

Beijing Anzhen Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

Beijing Shijitan Hospital; 🇨🇳 Beijing, Beijing, China

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China

Peking University Sixth Hospital; 🇨🇳 Beijing, Beijing, China

Union Hospital Tongji Mecial College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hebei, China

The Second Affiliated Hospital of Nanchang University; 🇨🇳 Nanchang, Jiangxi, China

Huadong Hospital Affiliated to Fudan University; 🇨🇳 Shanghai, Shanghai, China

Shanghai Mental Health Center; 🇨🇳 Shanghai, Shanghai, China

Shanghai Changzheng Hospital; 🇨🇳 Shanghai, Shanghai, China

Tianjin Huanhu Hospital; 🇨🇳 Tianjin, Tianjin, China

The First Teaching Hospital of Xinjiang Medical University; 🇨🇳 Ürümqi, Xinjiang, China

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China

The First Affiliated Hospital of Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China

Ningbo Kangning Hospital; 🇨🇳 Ningbo, Zhejiang, China

The First Affiliated Hospital, Wenzhou Medical College; 🇨🇳 Wenzhou, Zhejiang, China

Peking University First Hospital; 🇨🇳 Beijing, Beijing, China