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

This study has been completed.
Sponsor:
Collaborator:
Beijing Novartis Pharma
Information provided by (Responsible Party):
Huali Wang, Peking University
ClinicalTrials.gov Identifier:
NCT01779310
First received: January 24, 2013
Last updated: April 23, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition
Mild Cognitive Impairment
Alzheimer's Disease
Dementia

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 2 Months
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Peking University:

Primary Outcome Measures:
  • Rate of cognitive assessment administration [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of anti-dementia prescription [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • compliance rate of anti-dementia prescription [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Enrollment: 1024
Study Start Date: November 2012
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Alzheimer's disease
Outpatients with clinically significant cognitive impairment per judgment of the participating physicians are enrolled.

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

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
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.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01779310

  Show 28 Study Locations
Sponsors and Collaborators
Peking University
Beijing Novartis Pharma
Investigators
Principal Investigator: Huali Wang, MD/PhD Peking University Institute of Mental Health (Sixth Hospital)
  More Information

No publications provided

Responsible Party: Huali Wang, Associate Professor, Peking University
ClinicalTrials.gov Identifier: NCT01779310     History of Changes
Other Study ID Numbers: CENA731DCN01T
Study First Received: January 24, 2013
Last Updated: April 23, 2013
Health Authority: China: Ethics Committee

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Cognition Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 22, 2013