Shanghai Mild Cognitive Impairment Cohort Study
Shanghai Cohort Study on Mild Cognitive Impairment for Early Detection of Alzheimer's Disease
1 other identifier
observational
400
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2012
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 15, 2012
CompletedFirst Posted
Study publicly available on registry
March 13, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2017
CompletedApril 25, 2018
April 1, 2018
5 years
February 15, 2012
April 24, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to Conversion from MCI to "Probable AD Dementia"
3 years
Secondary Outcomes (5)
Time to Conversion from MCI to "Possible AD Dementia" or "Probable AD Dementia"
3 years
Time to Conversion from MCI to "All-cause Dementia"
3 years
Overall survival
3 years
Changes in Neuropsychological examinations
baseline, annual and 3 years
Changes in MRI
baseline, annual and 3 years
Study Arms (1)
single-group MCI patients
Eligibility Criteria
Subjects
You may qualify if:
- Cognitive concern reflecting a change in cognition reported by the patient or informant or clinician
- Mini-Mental State Examination (MMSE) scores between 18-30 (inclusive)
- Clinical Dementia Rating (CDR) =0.5; Memory Box score must be at least 0.5
- Objective memory loss\* as evidenced by Auditory Verbal Learning test (AVLT-HS)
- Essentially preserved activities of daily living based on Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)
- Not-demented, as defined by '"All-cause Dementia" (see 3.4. All-cause Dementia)
- Willing to and able to undergo all test procedures including neuroimaging, and agree to longitudinal follow up
- Written informed consent for the participation of this study including repeated neuropsychological tests and MRI scans
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Neurology, Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200040, China
Related Publications (1)
Zhou B, Zhao Q, Kojima S, Ding D, Higashide S, Nagai Y, Guo Q, Kagimura T, Fukushima M, Hong Z. One-year Outcome of Shanghai Mild Cognitive Impairment Cohort Study. Curr Alzheimer Res. 2019;16(2):156-165. doi: 10.2174/1567205016666181128151144.
PMID: 30484408DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Yoji Nagai, MD,PhD
Translational Research Informatics Center, Foundation for Biomedical Research and Innovation, Kobe,Japan
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2012
First Posted
March 13, 2012
Study Start
February 1, 2012
Primary Completion
February 1, 2017
Study Completion
July 31, 2017
Last Updated
April 25, 2018
Record last verified: 2018-04