NCT02225964

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 26, 2014

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

July 2, 2020

Status Verified

June 1, 2020

Enrollment Period

3.9 years

First QC Date

August 24, 2014

Last Update Submit

June 30, 2020

Conditions

Keywords

APOEε4

Outcome Measures

Primary Outcomes (1)

  • the conversion of aMCI patients with APOEε4 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

Study Arms (1)

aMCIp,aMCIs

progressive aMCI,stable aMCI

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

aMCI patients with APOEε4

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurolgy,Xuanwu Hospital of Capital Medical University

Beijing, Beijing Municipality, 100053, China

Location

Related Publications (3)

  • Lin H, Li M, Zhan Y, Lin L, Yang K, Hu S, Han Y. Disrupted white matter functional connectivity in aMCI APOEepsilon4 carriers: a resting-state study. Brain Imaging Behav. 2021 Aug;15(4):1739-1747. doi: 10.1007/s11682-020-00367-7.

  • 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.

  • Chen GQ, Sheng C, Li YX, Yu Y, Wang XN, Sun Y, Li HY, Li XY, Xie YY, Han Y. Neuroimaging basis in the conversion of aMCI patients with APOE-epsilon4 to AD: study protocol of a prospective diagnostic trial. BMC Neurol. 2016 May 12;16:64. doi: 10.1186/s12883-016-0587-2.

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chief physician

Study Record Dates

First Submitted

August 24, 2014

First Posted

August 26, 2014

Study Start

January 1, 2014

Primary Completion

December 1, 2017

Study Completion

December 1, 2018

Last Updated

July 2, 2020

Record last verified: 2020-06

Locations