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Completed

NCT Number: NCT01552265

Shanghai Mild Cognitive Impairment Cohort Study

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.

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Key information

Conditions

Mild Cognitive Impairment Alzheimer Disease Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

Up to 90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Neurology, Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200040, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Time to Conversion from MCI to "Probable AD Dementia"

    Time frame: 3 years

Secondary outcomes

  1. Time to Conversion from MCI to "Possible AD Dementia" or "Probable AD Dementia"

    Time frame: 3 years

  2. Time to Conversion from MCI to "All-cause Dementia"

    Time frame: 3 years

  3. Overall survival

    Time frame: 3 years

  4. Changes in Neuropsychological examinations

    Time frame: baseline, annual and 3 years

  5. Changes in MRI

    Time frame: baseline, annual and 3 years

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Fudan University

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Mar 13, 2012
Registry last updated
Apr 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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