Shanghai Mild Cognitive Impairment Cohort Study

NCT ID: NCT01552265

Last Updated: 2018-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-02-29

Study Completion Date

2017-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Mild Cognitive Impairment

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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single-group MCI patients

No interventions assigned to this group

Eligibility Criteria

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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
Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role collaborator

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yoji Nagai, MD,PhD

Role: STUDY_DIRECTOR

Translational Research Informatics Center, Foundation for Biomedical Research and Innovation, Kobe,Japan

Locations

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Department of Neurology, Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 30484408 (View on PubMed)

Related Links

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Other Identifiers

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TRIAD1109

Identifier Type: -

Identifier Source: org_study_id

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