Shanghai Mild Cognitive Impairment Cohort Study | NCT01552265

Studies
Shanghai Mild Cognitive Impairment Cohort Study

NCT01552265

Sponsor

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

Status

Completed

Last Update Posted

Apr 25, 2018Actual

Enrollment

400Actual

Phase

Not provided

Conditions

Mild Cognitive Impairment

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2012

Primary Completion Date

Feb 2017Actual

Completion Date

Jul 31, 2017Actual

First Submitted Date

Feb 15, 2012

First Submission Date that Met QC Criteria

Mar 8, 2012

First Posted Date

Mar 13, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 24, 2018

Last Update Posted Date

Apr 25, 2018Actual

Name	Class
Fudan University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

400Actual

Label	Type	Description	Intervention Names
single-group MCI patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to Conversion from MCI to "Probable AD Dementia"		3 years

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

90 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Subjects

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yoji Nagai, MD,PhD	Translational Research Informatics Center, Foundation for Biomedical Research and Innovation, Kobe,Japan	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Neurology, Huashan Hospital, Fudan University		Shanghai	Shanghai Municipality	200040	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30484408	Derived	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.

ID	Term
D060825	Cognitive Dysfunction
D000544	Alzheimer Disease

ID	Term
D003072	Cognition Disorders
D019965	Neurocognitive Disorders
D001523	Mental Disorders
D003704	Dementia