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CompletedNCT01779310Updated Jul 25, 2017

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

An observational study in Mild Cognitive Impairment, Alzheimer's Disease and Dementia, sponsored by Peking University. Completed at 28 sites in China. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2017-07-25.

Sponsored by Peking University · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
1,024
Ages
45 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Mild Cognitive Impairment
  • Alzheimer's Disease
  • Dementia
03

In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.

This study's enrollment of 1,024 is above the median of 200 across 751 observational studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Peking University is the lead sponsor of 411 studies on the registry; 122 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

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.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
1,024 participants (actual)
Target follow-up
2 Months
Patient registry
Yes

Groups and cohorts

  • Alzheimer's disease

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

06

What researchers measure

Primary outcomes

  1. Rate of cognitive assessment administration

    rate of cognitive assessment administration for diagnosing dementia

    Time frame: 2 months

Secondary outcomes

  1. Rate of anti-dementia prescription

    rate of anti-dementia prescription for people with dementia

    Time frame: 2 months

Other outcomes

  1. compliance rate of anti-dementia prescription

    rate of continuous using anti-dementia drugs among patients with dementia

    Time frame: 2 months

07

Study locations

28 sites
  • 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 First Hospital
    Beijing, Beijing, China
  • Peking University People's Hospital
    Beijing, Beijing, China
  • Peking University Sixth Hospital
    Beijing, Beijing, China
  • Peking University Third Hospital
    Beijing, Beijing, China
  • Guangzhou Brain Hospital
    Guangzhou, Guangdong, China
  • The Second Affiliated Hospital of Guangzhou Medical University
    Guangzhou, Guangdong, China
  • The First Hospital of Hebei Medical University
    Shijiazhuang, Hebei, China
  • Union Hospital Tongji Mecial College, Huazhong University of Science and Technology
    Wuhan, Hebei, China
  • Nanjing Brain Hospital
    Nanjing, Jiangsu, China
  • The Second Affiliated Hospital of Nanchang University
    Nanchang, Jiangxi, 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
  • Huadong Hospital Affiliated to Fudan University
    Shanghai, Shanghai, China
  • Shanghai Changzheng Hospital
    Shanghai, Shanghai, China
  • Shanghai Mental Health Center
    Shanghai, Shanghai, China
  • Mental Health Center, West China Hospital, Sichuan University
    Chengdu, Sichuan, China
  • General Hospital, Tianjin Medical University
    Tianjin, Tianjin, 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
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 25, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01779310
Lead sponsor
Peking University
Collaborators
Beijing Novartis Pharma
Responsible party
Huali Wang (Associate Professor, Peking University) — Principal investigator
First posted
Jan 30, 2013
Start date
Nov 2012
Primary completion
Apr 2013
Completion
Apr 2013
Last update
Jul 25, 2017

Study contacts

Huali Wang, MD/PhD
principal investigator · Peking University Institute of Mental Health (Sixth Hospital)

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.

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