Multi-modality MRI Study on Differences in Conversion of aMCI Patients With APOEε4 to AD

June 30, 2020 updated by: XuanwuH 2
This study is to find out the imaging marker and the changing laws of the marker during the course of the disease. The final purpose is to provide scientific evidence for new prevention, diagnosis and treatment of Alzheimer's disease.

Study Overview

Status

Completed

Conditions

Detailed Description

It is an urgent problem in the field of cognitive neuroscience to tell the conversion progression of amnestic mild cognitive impairment(aMCI) patients with Apolipoproteinε4(APOEε4) to Alzheimer's Disease(AD). Based on our preliminary work, we will study the special group of aMCI patients with APOEε4 with multi-modality magnetic resonance imaging (resting-state functional MRI, structural MRI and diffusion tensor imaging) longitudinally. Besides, we will also detect the APOE genotype of each sample and enlarge the sample size. According to situation of the conversion or non-conversion and differences in the conversion progression, we will analyze the data between the inter-groups and intra-groups, compare the imaging data of baseline and follow-up, find the prediction imaging marker of AD and optimize the reliability and validity.

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100053
        • Department of Neurolgy,Xuanwu Hospital of Capital Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

aMCI patients with APOEε4

Description

Inclusion Criteria:

  • Complaint about memory loss 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
  • Failure to meet the criteria for dementia
  • Carrying susceptible gene APOEε4
  • Must be able to accept examination of MRI, sight and hearing allow to complete test

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
aMCIp,aMCIs
progressive aMCI,stable aMCI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the conversion of aMCI patients with APOEε4 to AD
Time Frame: one year
According to situation of the conversion or non-conversion and differences in the conversion progression, we will analyze the data between the inter-groups and intra-groups, compare the imaging data of baseline and follow-up, find the prediction imaging marker of AD and optimize the reliability and validity.
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

XuanwuH 2

Collaborators

Xuanwu Hospital, Beijing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

August 24, 2014

First Submitted That Met QC Criteria

August 24, 2014

First Posted (Estimate)

August 26, 2014

Study Record Updates

Last Update Posted (Actual)

July 2, 2020

Last Update Submitted That Met QC Criteria

June 30, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XuanwuH 2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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