Skip to main content
OpenTrials
Completed

NCT Number: NCT02353884

Multi-modality MRI Study on Prediction for Mild Cognitive Impairment Conversion

The purpose of this study is to find the characteristics of mild cognitive impairment (MCI) using technology of Multi-Modality MRI , including structural MRI, functional MRI and diffusion tensor imaging(DTI). Then analyze the difference between progressive MCI (MCIp) and stable MCI (MCIs) and further construct the predictable classifier from MCI to Alzheimer's disease (AD) based on Multi-Modality MRI characteristics of MCI patients.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

55 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Neurolgy,Xuanwu Hospital of Capital Medical University

Beijing, Beijing Municipality, 100053, China

About this study

The cognition of MCI is between normal healthy and AD, which is thought the transitional stage of AD. Patients with MCI have heavy risk to convert to AD, so in this study, the investigators focus on the exploration of the characteristics of mild cognitive impairment (MCI) using technology of Multi-Modality MRI, including structural MRI, functional MRI and DTI. Then the investigators further study the patients who convert to AD and explore their MRI characteristics on baseline, in order to construct the predictable classifier from MCI to AD. The investigators want to achieve the early diagnosis of AD and help clinicians interfere with the progress of this disease.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age is between 55 to 75 years old
  • Memory loss complaint and confirmed by an informant
  • Cognitive impairment in single or multiple domains, adjusted for age and education
  • Normal or near-normal performance on general cognitive function and no or minimum impairment of daily life activities
  • A Clinical Dementia Rating (CDR) score is 0.5 and consistent with the boundary of neuropsychological scale
  • Failure to meet the criteria for dementia
  • Must be able to accept examination of MRI, sight and hearing allow to complete test
  • Right handedness

Exclusion criteria

  • Other diseases that cause cognitive impairment, such as thyroid disease, stroke and so on
  • People who have severe visual and hearing impairment

Treatment and study plan

Primary outcomes

  1. the accuracy of a predictable classifier from MCI to AD based on Multi-Modality MRI characteristics of MCI patients.

    Time frame: 2 years

    one-hundred MCI subjects and 50 healthy controls recruited underwent structure,resting-state functional magnetic resonance imaging and diffusion tensor imaging.After 2-year follow-up,the MCI subjects were divided into progressive MCI(MCIp) and stable MCI(MCIs).Based on differences among MCIp，MCIs and healthy controls in baseline neuroimaging data，some suitable indicators were selected，and then a predictable classifier from MCI to AD based on multi-modality MRI was constructed.At last，the leave-one-out cross validation analysis were conducted to estimate the accuracy of the classifier.The classification accuracy was measured by the proportion of MCI subjects that were correctly classified into the MCIp or MCIs groups

Secondary outcomes

  1. characteristic changes of brain structure in progressive MCI

    Time frame: 2 years

    voxel based morphometry (VBM) and cortical-thicknessanalysis（CTA）based on structural MRI were used to characterize the changes of brain structure in the MCIp comparing with the MCIs and healthy control

  2. characteristic changes of anatomical connectivity in progressing MCI

    Time frame: 2 years

    region of interest(ROI),voxel and fiber bundle analysis based on diffusion tensor imaging were used to detect differences among the MCIp，MCIs and healthy control in fractional anisotropy(FA) and mean diffusivity(MD).

  3. characteristic changes of functional connectivity in progressing MCI

    Time frame: 2 years

    functional connectivity（FC） was compared among the MCIp, MCIs and healthy control using resting-state functional magnetic resonance imaging.

Sponsors and collaborators

Lead sponsor

XuanwuH 2

Other

Collaborators

  • Xuanwu Hospital, Beijing

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Feb 3, 2015
Registry last updated
Feb 3, 2015

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.