Clinical trial NCT01779310: Clinical Pathway for Alzheimer's Disease in China (CPAD)
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mild Cognitive Impairment
Alzheimer's Disease
Dementia
Lead sponsor: Peking University
Sponsor class: OTHER
Collaborators: name: Beijing Novartis Pharma
First posted: 2013-01-30
Enrollment: 1024
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatients with clinically significant cognitive impairment per judgment of the participating physicians are registered.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of cognitive assessment administration
timeFrame: 2 months
Secondary outcomes:
measure: Rate of anti-dementia prescription
timeFrame: 2 months
Other outcomes:
measure: compliance rate of anti-dementia prescription
timeFrame: 2 months
Locations:
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical University
state: Anhui
city: Beijing
country: China
facility: Beijing Anzhen Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Shijitan Hospital
state: Beijing
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University Sixth Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Guangzhou
country: China
facility: Guangzhou Brain Hospital
state: Guangdong
city: Guangzhou
country: China
facility: The Second Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Shijiazhuang
country: China
facility: The First Hospital of Hebei Medical University
state: Hebei
city: Wuhan
country: China
facility: Union Hospital Tongji Mecial College, Huazhong University of Science and Technology
state: Hebei
city: Nanjing
country: China
facility: Nanjing Brain Hospital
state: Jiangsu
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University
state: Jiangxi
city: Xi'an
country: China
facility: First Affiliated Hospital of Medical College of Xi'an Jiaotong University
state: Shaanxi
city: Jinan
country: China
facility: Shandong Mental Health Center
state: Shandong
city: Jinan
country: China
facility: Shandong Provincial Hospital
state: Shandong
city: Shanghai
country: China
facility: Huadong Hospital Affiliated to Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Changzheng Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Mental Health Center
state: Shanghai
city: Chengdu
country: China
facility: Mental Health Center, West China Hospital, Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: General Hospital, Tianjin Medical University
state: Tianjin
city: Tianjin
country: China
facility: Tianjin Huanhu Hospital
state: Tianjin
city: Ürümqi
country: China
facility: The First Teaching Hospital of Xinjiang Medical University
state: Xinjiang
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
state: Zhejiang
city: Hangzhou
country: China
facility: The First Affiliated Hospital of Zhejiang University
state: Zhejiang
city: Ningbo
country: China
facility: Ningbo Kangning Hospital
state: Zhejiang
city: Wenzhou
country: China
facility: The First Affiliated Hospital, Wenzhou Medical College
state: Zhejiang
Study officials:
affiliation: Peking University Institute of Mental Health (Sixth Hospital)
name: Huali Wang, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References: