Mild Cognitive ImpairmentNCT04277767
The Role of Ophthalmologic Tests and EEG Imaging in Alzheimer's Disease
An observational study of Mild Cognitive Impairment, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- observational
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2022to 1 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Clinical diagnosis of Alzheimer's Disease
Who cannot join
- neurologic disorders
- psychiatric disorders
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Ophthalmic Center
Guangzhou, Guangdong, 510000
Li Gu, Dr., 15889937313 ext. +86, guli7@mail2.sysu.edu.cn
Jin yuan, Prof.
About this study
Official title: 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.
- Conditions
- Mild Cognitive Impairment
- Being tested
- observational
- Keywords
- AD EEG OCT biomarker
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observationalDiagnostic test
No intervention
| Study group | Role | What they receive |
|---|---|---|
| mild cognitive impairment (MCI) | observational Receives: Diagnostic Test: observational | |
| Patients with mild to moderate AD | observational Receives: Diagnostic Test: observational | |
| Normal controls | observational Receives: Diagnostic Test: observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
OCT retinal and choroidal thickness
retinal structural anatomy
Measured: 2 days
Retinal Photography vascular caliber
use Retinal Photography to detect vascular caliber
Measured: 2 days
functional connection strength in the brain network
record resting-state EEG, use graph theory to calculate the functional connection strength
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start1 Sep 2022 (estimated)
- Primary completion1 Feb 2023 (estimated)
- Study completion1 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Zhongshan Ophthalmic Center, Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin Yuan, Zhongshan Ophthalmic Center, Sun Yat-sen University
- Investigators
- Jin Yuan, phD, Principal investigator, Zhongshan Ophthalmological Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04277767
- Sponsor's protocol ID
- AD2020
- Status last verified
- Mar 2021
- First submitted
- 13 Jan 2020
- Last updated
- 1 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Combination of Ophthalmologic Tests and EEG Imaging as a New Biomarker for Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT04277767
- Acronym / sponsor ID
- AD2020
- Conditions
- Mild Cognitive Impairment
- Keywords
- AD EEG OCT biomarker
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 1 Feb 2023 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 20 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| mild cognitive impairment (MCI) | – | Diagnostic Test: observationalobservational |
| Patients with mild to moderate AD | – | Diagnostic Test: observationalobservational |
| Normal controls | – | Diagnostic Test: observationalobservational |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Clinical diagnosis of Alzheimer's Disease
Key exclusion criteria (2 listed)
- neurologic disorders
- psychiatric disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observationalNo intervention | Diagnostic test | Normal controls, Patients with mild to moderate AD, mild cognitive impairment (MCI) |
Primary outcome
OCT retinal and choroidal thickness
Time frame: 2 days
retinal structural anatomy
Retinal Photography vascular caliber
Time frame: 2 days
use Retinal Photography to detect vascular caliber
functional connection strength in the brain network
Time frame: 7 days
record resting-state EEG, use graph theory to calculate the functional connection strength
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Mild Cognitive Impairment
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingObservational study
Community-based Screening for Alzheimer's Disease
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
RecruitingObservational study
InRAD Observational Study
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
Recruiting
Treating Insomnia in Mild Cognitive Impairment
Mild Cognitive Impairment (MCI), Insomnia
Recruiting
Telehealth-Adapted Compensatory Training and Intervention for Cognition
MCI, Mild Cognitive Impairment
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jin Yuan, phD principal investigator
Zhongshan Ophthalmological Center, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild Cognitive Impairment, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jin Yuan, phD (13825141659, yuanjincornea@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OCT retinal and choroidal thickness (time frame: 2 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2021.