Overview

This trial is active, not recruiting.

Condition mild cognitive impairment
Sponsor Translational Research Informatics Center, Kobe, Hyogo, Japan
Collaborator Fudan University
Start date February 2012
End date June 2017
Trial size 400 participants
Trial identifier NCT01552265, TRIAD1109

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm

Primary Outcomes

Measure
Time to Conversion from MCI to "Probable AD Dementia"
time frame: 3 years

Secondary Outcomes

Measure
Time to Conversion from MCI to "Possible AD Dementia" or "Probable AD Dementia"
time frame: 3 years
Time to Conversion from MCI to "All-cause Dementia"
time frame: 3 years
Overall survival
time frame: 3 years
Changes in Neuropsychological examinations
time frame: baseline, annual and 3 years
Changes in MRI
time frame: baseline, annual and 3 years

Eligibility Criteria

Male or female participants up to 90 years old.

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

Additional Information

Official title Shanghai Cohort Study on Mild Cognitive Impairment for Early Detection of Alzheimer's Disease
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Translational Research Informatics Center, Kobe, Hyogo, Japan.