Shanghai Mild Cognitive Impairment Cohort Study

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

Status: Completed

Conditions: Mild Cognitive Impairment

Study type: Observational

Funder types: Other

Identifiers

NCT01552265

TRIAD1109

Details and patient eligibility

About

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.

Enrollment: 400 patients

Sex: All

Ages: Under 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

400 participants in 1 patient group

single-group MCI patients