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Shanghai Mild Cognitive Impairment Cohort Study

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2015 by Translational Research Informatics Center, Kobe, Hyogo, Japan.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01552265
First Posted: March 13, 2012
Last Update Posted: September 21, 2015
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:
Fudan University
Information provided by (Responsible Party):
Translational Research Informatics Center, Kobe, Hyogo, Japan
  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 ]

Secondary Outcome Measures:
  • Time to Conversion from MCI to "Possible AD Dementia" or "Probable AD Dementia" [ Time Frame: 3 years ]
  • Time to Conversion from MCI to "All-cause Dementia" [ Time Frame: 3 years ]
  • Overall survival [ Time Frame: 3 years ]
  • Changes in Neuropsychological examinations [ Time Frame: baseline, annual and 3 years ]
  • Changes in MRI [ Time Frame: baseline, annual and 3 years ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 90 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01552265


Locations
China, Shanghai
Department of Neurology, Huashan Hospital, Fudan University
Shanghai, Shanghai, China, 200040
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:
Responsible Party: Translational Research Informatics Center, Kobe, Hyogo, Japan
ClinicalTrials.gov Identifier: NCT01552265     History of Changes
Other Study ID Numbers: TRIAD1109
First Submitted: February 15, 2012
First Posted: March 13, 2012
Last Update Posted: September 21, 2015
Last Verified: September 2015

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

Additional relevant MeSH terms:
Alzheimer Disease
Cognitive Dysfunction
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders