Shanghai Mild Cognitive Impairment Cohort Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Translational Research Informatics Center, Kobe, Hyogo, Japan
Sponsor:
Collaborator:
Fudan University
Information provided by (Responsible Party):
Translational Research Informatics Center, Kobe, Hyogo, Japan
ClinicalTrials.gov Identifier:
NCT01552265
First received: February 15, 2012
Last updated: February 20, 2014
Last verified: February 2014
  Purpose

This study was planned 1) to identify individuals with Mild Cognitive Impairment (MCI) who convert to Alzheimer's Disease (AD), and 2) to explore factors associated with the conversion.


Condition
Mild Cognitive Impairment

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Shanghai Cohort Study on Mild Cognitive Impairment for Early Detection of Alzheimer's Disease

Resource links provided by NLM:


Further study details as provided by Translational Research Informatics Center, Kobe, Hyogo, Japan:

Primary Outcome Measures:
  • Time to Conversion from MCI to "Probable AD Dementia" [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to Conversion from MCI to "Possible AD Dementia" or "Probable AD Dementia" [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Time to Conversion from MCI to "All-cause Dementia" [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Changes in Neuropsychological examinations [ Time Frame: baseline, annual and 3 years ] [ Designated as safety issue: No ]
  • Changes in MRI [ Time Frame: baseline, annual and 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: February 2012
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
single-group MCI patients

  Eligibility

Ages Eligible for Study:   up to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Subjects

Criteria

Inclusion Criteria:

  1. Cognitive concern reflecting a change in cognition reported by the patient or informant or clinician
  2. Mini-Mental State Examination (MMSE) scores between 18-30 (inclusive)
  3. Clinical Dementia Rating (CDR) =0.5; Memory Box score must be at least 0.5
  4. Objective memory loss* as evidenced by Auditory Verbal Learning test (AVLT-HS)
  5. Essentially preserved activities of daily living based on Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)
  6. Not-demented, as defined by '"All-cause Dementia" (see 3.4. All-cause Dementia)
  7. Willing to and able to undergo all test procedures including neuroimaging, and agree to longitudinal follow up
  8. Written informed consent for the participation of this study including repeated neuropsychological tests and MRI scans
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01552265

Contacts
Contact: Qianhua Zhao, MD,PhD +86-21-52888158

Locations
China, Shanghai
Department of Neurology, Huashan Hospital, Fudan University Recruiting
Shanghai, Shanghai, China, 200040
Contact: Qianhua Zhao, MD,PhD    +86-21-52888158      
Contact: Qihao Guo, MD,PhD    +86-21-52888158      
Principal Investigator: Zhen Hong, MD         
Sponsors and Collaborators
Translational Research Informatics Center, Kobe, Hyogo, Japan
Fudan University
Investigators
Study Director: Yoji Nagai, MD,PhD Translational Research Informatics Center, Foundation for Biomedical Research and Innovation, Kobe,Japan
  More Information

Additional Information:
No publications provided

Responsible Party: Translational Research Informatics Center, Kobe, Hyogo, Japan
ClinicalTrials.gov Identifier: NCT01552265     History of Changes
Other Study ID Numbers: TRIAD1109
Study First Received: February 15, 2012
Last Updated: February 20, 2014
Health Authority: China:Huashan Instututional Review Board

Keywords provided by Translational Research Informatics Center, Kobe, Hyogo, Japan:
Mild Cognitive Impairment
Alzheimer's Disease

Additional relevant MeSH terms:
Alzheimer Disease
Cognition Disorders
Dementia
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 July 10, 2014