The Role of Ophthalmologic Tests and EEG Imaging in Alzheimer's Disease

March 30, 2021 updated by: Jin Yuan, Zhongshan Ophthalmic Center, Sun Yat-sen University

The Combination of Ophthalmologic Tests and EEG Imaging as a New Biomarker for Alzheimer's Disease

Alzheimer's disease (AD) is a prevalent, long-term progressive degenerative disorder with great social impact. It is currently thought that, in addition to neurodegeneration, vascular changes also play a role in the pathophysiology of the disease. Meantime, EEG resting state has also demonstrated significant change in patients with AD in neuroscience research area. Thus, the combination of these sensitive biomarkers would lead to a potential new biomarker for detection of AD, which has higher specificity and sensitivity.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

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

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Zhongshan Ophthalmic Center

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

50 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

We would recruit three groups of elders. One is the control group without cognitive impairment, one is the aMCI group which is deemed as the pre-stage of AD, and also the AD group.

Description

Inclusion Criteria:

  • Clinical diagnosis of Alzheimer's Disease

Exclusion Criteria:

  • neurologic disorders
  • psychiatric disorders

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
Intervention / Treatment
mild cognitive impairment (MCI)
observational
Diagnostic test: observational
No intervention
Patients with mild to moderate AD
observational
Diagnostic test: observational
No intervention
Normal controls
observational
Diagnostic test: observational
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OCT retinal and choroidal thickness
Time Frame: 2 days
retinal structural anatomy
2 days
Retinal Photography vascular caliber
Time Frame: 2 days
use Retinal Photography to detect vascular caliber
2 days
functional connection strength in the brain network
Time Frame: 7 days
record resting-state EEG, use graph theory to calculate the functional connection strength
7 days

Collaborators and Investigators

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

Sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

Investigators

  • Principal Investigator: Jin Yuan, phD, Zhongshan Ophthalmological Center, Sun Yat-sen University

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 (ANTICIPATED)

September 1, 2022

Primary Completion (ANTICIPATED)

February 1, 2023

Study Completion (ANTICIPATED)

July 1, 2023

Study Registration Dates

First Submitted

January 13, 2020

First Submitted That Met QC Criteria

February 18, 2020

First Posted (ACTUAL)

February 20, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 1, 2021

Last Update Submitted That Met QC Criteria

March 30, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AD2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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