- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04236375
Eye Movement and Cognitive Dysfunction (EMCD)
January 18, 2020 updated by: Haotian Lin, Sun Yat-sen University
The Development of an Artificial Intelligence Platform for Screening and Referral of Cognitive Dysfunction
There is association between eye movement disorder and cognitive dysfunction.
Therefore, utilizing eye movement and screening for cognitive dysfunction is feasible.
In the present study, we will develop an artificial intelligence platform to screening for cognitive dysfunction by inspecting the function of eye movement.
Futher more, based on the screening results, the platform will offer referral suggestions.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
700
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
- Name: Haotian Lin, M.D.,Ph.D
- Phone Number: 86-13802793086
- Email: gddlht@aliyun.com
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
45 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Subjects who are over 45 years old with or without cognitive dysfunction.
Description
Inclusion Criteria:
- ①Subjects who are diagnosed as mild cognitive decline, Alzheimer's disease, Vascular dementia, Lewy body dementia, Frontotemporal dementia, other dementia and normal by neurologist.
- ②Subjects who can cooperate with the inspection.
- ③Subjects who agree to participate in the study and sign the consent form
Exclusion Criteria:
- ①Subjects who cannot do the inspection.
- ②Subjects who suffer from diseases that compromise the inspection.
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 |
---|
Normal
Subjects over 45 years old without cognitive dysfunction
|
Mild cognitive decline
Subjects who are diagnosed as mild cognitive decline(MCI) according to neurologists.
|
Alzheimer's disease
Subjects who are diagnosed as Alzheimer's disease(AD) according to neurologists.
|
Vascular dementia
Subjects who are diagnosed as vascular dementia(VD) according to neurologists.
|
Lewy body dementia
Subjects who are diagnosed as Lewy body demenita (DLB) according to neurologists.
|
Frontotemporal dementia
Subjects who are diagnosed as Frontotemporal demenita (FD) according to neurologists.
|
Other dementia
Subjects who are diagnosed as dementia but are not as AD, VD, DLB OR FD.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Area under the curve
Time Frame: up to 1 month
|
AUC values for predicting whether subject has cognitive impairment or not
|
up to 1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Accuracy, true positive rate, and true negetive rate
Time Frame: up to 1 month
|
The performance of this artificial platform
|
up to 1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Haotian Lin, M.D.,Ph.D, Zhongshan Ophthalmic Center, Sun Yat-sen University
- Study Director: Xun Wang, M.D.,Ph.D, Zhongshan Ophthalmic Center, Sun Yat-sen University
- Principal Investigator: Shuyi Zhang, M.D., Zhongshan Ophthalmic 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)
February 1, 2020
Primary Completion (ANTICIPATED)
August 1, 2020
Study Completion (ANTICIPATED)
December 1, 2020
Study Registration Dates
First Submitted
January 18, 2020
First Submitted That Met QC Criteria
January 18, 2020
First Posted (ACTUAL)
January 22, 2020
Study Record Updates
Last Update Posted (ACTUAL)
January 22, 2020
Last Update Submitted That Met QC Criteria
January 18, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Eye movement-cognitive decline
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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