NCT04277767

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

January 13, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 20, 2020

Completed
2.5 years until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

April 1, 2021

Status Verified

March 1, 2021

Enrollment Period

5 months

First QC Date

January 13, 2020

Last Update Submit

March 30, 2021

Conditions

Keywords

AD EEG OCT biomarker

Outcome Measures

Primary Outcomes (3)

  • OCT retinal and choroidal thickness

    retinal structural anatomy

    2 days

  • Retinal Photography vascular caliber

    use Retinal Photography to detect vascular caliber

    2 days

  • functional connection strength in the brain network

    record resting-state EEG, use graph theory to calculate the functional connection strength

    7 days

Study Arms (3)

mild cognitive impairment (MCI)

observational

Diagnostic Test: observational

Patients with mild to moderate AD

observational

Diagnostic Test: observational

Normal controls

observational

Diagnostic Test: observational

Interventions

observationalDIAGNOSTIC_TEST

No intervention

Normal controlsPatients with mild to moderate ADmild cognitive impairment (MCI)

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Clinical diagnosis of Alzheimer's Disease

You may not qualify if:

  • neurologic disorders
  • psychiatric disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Jin Yuan, phD

    Zhongshan Ophthalmological Center, Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant dean

Study Record Dates

First Submitted

January 13, 2020

First Posted

February 20, 2020

Study Start

September 1, 2022

Primary Completion

February 1, 2023

Study Completion

July 1, 2023

Last Updated

April 1, 2021

Record last verified: 2021-03

Locations