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CompletedNCT02353884Updated Feb 3, 2015

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

An observational study in Mild Cognitive Impairment and Alzheimer's Disease, sponsored by XuanwuH 2. Completed at 1 site in China. Open to participants aged 55 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-02-03.

Sponsored by XuanwuH 2 · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
150
Ages
55 Years to 75 Years
Sex
All
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Study summary

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.

Read the detailed description

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.

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Conditions studied

  • Mild Cognitive Impairment
  • Alzheimer's Disease
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In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.

This study's enrollment of 150 is below the median of 200 across 751 observational studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

XuanwuH 2 is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
55 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

The cognition of MCI is between healthy control and AD, which is thought the transitional stage of AD. Patients with MCI have heavy risk to convert to AD.

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

Exclusion Criteria:

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

Observational model
Case-control
Time perspective
Prospective
Enrollment
150 participants (actual)
Patient registry
No

Groups and cohorts

  • MCIp,MCIs

    progressive MCI:those convert to AD in two years, stable MCI

  • MCI,HC

    mild cognitive impairment, healthy control

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What researchers measure

Primary outcomes

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

    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

    Time frame: 2 years

Secondary outcomes

  1. characteristic changes of brain structure in progressive MCI

    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

    Time frame: 2 years

  2. characteristic changes of anatomical connectivity in progressing MCI

    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).

    Time frame: 2 years

  3. characteristic changes of functional connectivity in progressing MCI

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

    Time frame: 2 years

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Study locations

1 site
  • Department of Neurolgy,Xuanwu Hospital of Capital Medical University
    Beijing, Beijing 100053, China
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References and documents

Publications

  • Sheng C, Sun Y, Wang M, Wang X, Liu Y, Pang D, Liu J, Bi X, Du W, Zhao M, Li Y, Li X, Jiang J, Han Y. Combining Visual Rating Scales for Medial Temporal Lobe Atrophy and Posterior Atrophy to Identify Amnestic Mild Cognitive Impairment from Cognitively Normal Older Adults: Evidence Based on Two Cohorts. J Alzheimers Dis. 2020;77(1):323-337. doi: 10.3233/JAD-200016. PubMed 32716355 ↗
  • Yang L, Yan Y, Wang Y, Hu X, Lu J, Chan P, Yan T, Han Y. Gradual Disturbances of the Amplitude of Low-Frequency Fluctuations (ALFF) and Fractional ALFF in Alzheimer Spectrum. Front Neurosci. 2018 Dec 20;12:975. doi: 10.3389/fnins.2018.00975. eCollection 2018. PubMed 30618593 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 3, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02353884
Lead sponsor
XuanwuH 2
Collaborators
Xuanwu Hospital, Beijing
Responsible party
XuanwuH 2 (Chief physician, Xuanwu Hospital, Beijing) — Sponsor-investigator
First posted
Feb 3, 2015
Start date
Jan 2010
Primary completion
Dec 2011
Completion
Dec 2012
Last update
Feb 3, 2015

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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