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Shanghai Mild Cognitive Impairment Cohort Study

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ClinicalTrials.gov Identifier: NCT01552265
Recruitment Status : Completed
First Posted : March 13, 2012
Last Update Posted : April 25, 2018
Sponsor:
Collaborator:
Fudan University
Information provided by (Responsible Party):
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Brief Summary:
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 or disease
Mild Cognitive Impairment

Study Type : Observational
Actual Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Shanghai Cohort Study on Mild Cognitive Impairment for Early Detection of Alzheimer's Disease
Study Start Date : February 2012
Actual Primary Completion Date : February 2017
Actual Study Completion Date : July 31, 2017

Resource links provided by the National Library of Medicine


Group/Cohort
single-group MCI patients



Primary Outcome Measures :
  1. Time to Conversion from MCI to "Probable AD Dementia" [ Time Frame: 3 years ]

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


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Ages Eligible for Study:   up to 90 Years   (Child, Adult, Older Adult)
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

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 Center for Medical Innovation, Kobe, Hyogo, Japan
Fudan University
Investigators
Study Director: Yoji Nagai, MD,PhD Translational Research Informatics Center, Foundation for Biomedical Research and Innovation, Kobe,Japan

Additional Information:
Responsible Party: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
ClinicalTrials.gov Identifier: NCT01552265     History of Changes
Other Study ID Numbers: TRIAD1109
First Posted: March 13, 2012    Key Record Dates
Last Update Posted: April 25, 2018
Last Verified: April 2018

Keywords provided by Translational Research Center for Medical Innovation, 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