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

NCT ID: NCT01779310

Last Updated: 2017-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1024 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-11-30

Study Completion Date

2013-04-30

Brief Summary

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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

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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.

Conditions

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Mild Cognitive Impairment Alzheimer's Disease Dementia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Alzheimer's disease

Outpatients with clinically significant cognitive impairment per judgment of the participating physicians are enrolled.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Novartis Pharma

INDUSTRY

Sponsor Role collaborator

Peking University

OTHER

Sponsor Role lead

Responsible Party

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Huali Wang

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Huali Wang, MD/PhD

Role: PRINCIPAL_INVESTIGATOR

Peking University Institute of Mental Health (Sixth Hospital)

Locations

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The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Site Status

Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status

Beijing Shijitan Hospital

Beijing, Beijing Municipality, China

Site Status

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Site Status

Peking University First Hospital

Beijing, Beijing Municipality, China

Site Status

Peking University People's Hospital

Beijing, Beijing Municipality, China

Site Status

Peking University Sixth Hospital

Beijing, Beijing Municipality, China

Site Status

Peking University Third Hospital

Beijing, Beijing Municipality, China

Site Status

Guangzhou Brain Hospital

Guangzhou, Guangdong, China

Site Status

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Site Status

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Site Status

Union Hospital Tongji Mecial College, Huazhong University of Science and Technology

Wuhan, Hebei, China

Site Status

Nanjing Brain Hospital

Nanjing, Jiangsu, China

Site Status

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Site Status

First Affiliated Hospital of Medical College of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Site Status

Shandong Mental Health Center

Jinan, Shandong, China

Site Status

Shandong Provincial Hospital

Jinan, Shandong, China

Site Status

Huadong Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, China

Site Status

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, China

Site Status

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China

Site Status

Mental Health Center, West China Hospital, Sichuan University

Chengdu, Sichuan, China

Site Status

General Hospital, Tianjin Medical University

Tianjin, Tianjin Municipality, China

Site Status

Tianjin Huanhu Hospital

Tianjin, Tianjin Municipality, China

Site Status

The First Teaching Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

Site Status

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Site Status

The First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

Site Status

Ningbo Kangning Hospital

Ningbo, Zhejiang, China

Site Status

The First Affiliated Hospital, Wenzhou Medical College

Wenzhou, Zhejiang, China

Site Status

Countries

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China

Other Identifiers

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CENA731DCN01T

Identifier Type: -

Identifier Source: org_study_id

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