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

Dementia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01779310
• Other study ID #: CENA731DCN01T
• Status: Completed
• Phase: N/A
• First received: January 24, 2013
• Last updated: July 22, 2017
• Start date: November 2012
• Est. completion date: April 2013

Study information

• Verified date: July 2017
• Source: Peking University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1024
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Cognition Disorders
• Dementia
• Mild Cognitive Impairment

Locations

Country	Name	City	State
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	Mental Health Center, West China Hospital, Sichuan University	Chengdu	Sichuan
China	Guangzhou Brain Hospital	Guangzhou	Guangdong
China	The Second Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong
China	Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang
China	The First Affiliated Hospital of Zhejiang University	Hangzhou	Zhejiang
China	The First Affiliated Hospital of Anhui Medical University	Hefei	Anhui
China	Shandong Mental Health Center	Jinan	Shandong
China	Shandong Provincial Hospital	Jinan	Shandong
China	The Second Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	Nanjing Brain Hospital	Nanjing	Jiangsu
China	Ningbo Kangning Hospital	Ningbo	Zhejiang
China	Huadong Hospital Affiliated to Fudan University	Shanghai	Shanghai
China	Shanghai Changzheng Hospital	Shanghai	Shanghai
China	Shanghai Mental Health Center	Shanghai	Shanghai
China	The First Hospital of Hebei Medical University	Shijiazhuang	Hebei
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	The First Affiliated Hospital, Wenzhou Medical College	Wenzhou	Zhejiang
China	Union Hospital Tongji Mecial College, Huazhong University of Science and Technology	Wuhan	Hebei
China	First Affiliated Hospital of Medical College of Xi'an Jiaotong University	Xi'an	Shaanxi

Sponsors (2)

Lead Sponsor	Collaborator
Peking University	Beijing Novartis Pharma

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	compliance rate of anti-dementia prescription	rate of continuous using anti-dementia drugs among patients with dementia	2 months
Primary	Rate of cognitive assessment administration	rate of cognitive assessment administration for diagnosing dementia	2 months
Secondary	Rate of anti-dementia prescription	rate of anti-dementia prescription for people with dementia	2 months