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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01779310
First Posted: January 30, 2013
Last Update Posted: July 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Beijing Novartis Pharma
Information provided by (Responsible Party):
Huali Wang, Peking University
January 24, 2013
January 30, 2013
July 25, 2017
November 2012
April 2013   (Final data collection date for primary outcome measure)
Rate of cognitive assessment administration [ Time Frame: 2 months ]
rate of cognitive assessment administration for diagnosing dementia
Rate of cognitive assessment administration [ Time Frame: 2 months ]
Complete list of historical versions of study NCT01779310 on ClinicalTrials.gov Archive Site
Rate of anti-dementia prescription [ Time Frame: 2 months ]
rate of anti-dementia prescription for people with dementia
Rate of anti-dementia prescription [ Time Frame: 2 months ]
compliance rate of anti-dementia prescription [ Time Frame: 2 months ]
rate of continuous using anti-dementia drugs among patients with dementia
compliance rate of anti-dementia prescription [ Time Frame: 2 months ]
 
Clinical Pathway for Alzheimer's Disease in China (CPAD)
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

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.

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.

Observational [Patient Registry]
Observational Model: Case-Only
Time Perspective: Prospective
2 Months
Not Provided
Non-Probability Sample
Outpatients with clinically significant cognitive impairment per judgment of the participating physicians are registered.
  • Mild Cognitive Impairment
  • Alzheimer's Disease
  • Dementia
Not Provided
Alzheimer's disease
Outpatients with clinically significant cognitive impairment per judgment of the participating physicians are enrolled.
Not Provided
 
Completed
1024
April 2013
April 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
45 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01779310
CENA731DCN01T
Yes
Not Provided
Not Provided
Huali Wang, Peking University
Peking University
Beijing Novartis Pharma
Principal Investigator: Huali Wang, MD/PhD Peking University Institute of Mental Health (Sixth Hospital)
Peking University
July 2017