Shanghai Mild Cognitive Impairment Cohort Study

Mild Cognitive Impairment Clinical Trial

Official title:

Shanghai Cohort Study on Mild Cognitive Impairment for Early Detection of Alzheimer's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01552265
• Other study ID #: TRIAD1109
• Status: Completed
• First received: February 15, 2012
• Last updated: April 24, 2018
• Start date: February 2012
• Est. completion date: July 31, 2017

Study information

• Verified date: April 2018
• Source: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: July 31, 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction
• Mild Cognitive Impairment

Locations

Country	Name	City	State
China	Department of Neurology, Huashan Hospital, Fudan University	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan	Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Conversion from MCI to "Probable AD Dementia"		3 years
Secondary	Time to Conversion from MCI to "Possible AD Dementia" or "Probable AD Dementia"		3 years
Secondary	Time to Conversion from MCI to "All-cause Dementia"		3 years
Secondary	Overall survival		3 years
Secondary	Changes in Neuropsychological examinations		baseline, annual and 3 years
Secondary	Changes in MRI		baseline, annual and 3 years

External Links

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