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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02225964
Other study ID # XuanwuH 2
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2014
Est. completion date December 2018

Study information

Verified date June 2020
Source Xuanwu Hospital, Beijing
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date December 2018
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 APOEe4

- 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Department of Neurolgy,Xuanwu Hospital of Capital Medical University Beijing Beijing

Sponsors (2)

Lead Sponsor Collaborator
XuanwuH 2 Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary the conversion of aMCI patients with APOEe4 to AD 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
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