Age Related Macular DegenerationNCT06883461
Association Between Age-related Macular Degeneration and Cognitive Impairment Based on Exosome Proteomics
An observational study of Age Related Macular Degeneration and Mild Cognitive Impairment (MCI), run by Shanghai 10th People's Hospital at 1 site in China.
Trial summary
Aim: Preliminary serum exosomal proteomics of patients with dry age-related macular degeneration (AMD) and mild cognitive impairment (MCI) were analyzed using proteomics technology. Methods: Peripheral serum samples were collected from patients with AMD, MCI, comorbid conditions, and the control group. Read more about this study
- Who is it for?
- Ages 40 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Age Related Macular Degeneration, Mild Cognitive Impairment (MCI), Alzheimer's Disease (AD)
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2019to 3 Jun 2024
- How long will I take part?
- 1 Day
- 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 40 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients who attended the Department of Ophthalmology or Department of Neurology of Shanghai Tenth People's Hospital affiliated with Tongji University School of Medicine
Who may be able to join
- All dry AMD patients were diagnosed based on the Clinical Classification of Age-Related Macular Degeneration issued by the American Academy of Ophthalmology.
- All patients with MCI meet the Petersen criteria, including memory impairment, no abnormal cognitive function, dementia, or some cognitive impairment in daily life. A Mini-Mental State Examination (MMSE) score ≥24 points and a Montreal Cognitive Assessment (MoCA) score between 18 and 25 points were required.
Who cannot join
- The systemic physical exclusion criteria were as follows:(a) Metabolic syndromes such as diabetes or obesity;(b) Uncontrolled hypertension or hypotension;(c) Serious cardiac disease;(d) Neurological diseases, including Parkinson's disease, multiple sclerosis, or peripheral neuropathy;(e) Psychiatric diseases such as hallucinations or depressive disorders;(f) a history of brain injury, stroke, or substance abuse.
- The ocular exclusion criteria were as follows: (a) intraocular pressure(IOP) > 21 mmHg; (b) axial length(AL) > 25 mm or <22 mm; (c) anterior segment disease affecting fundus examination; (d) retinal pathologic changes associated with high myopia or serious refractive errors (>5D of spherical equivalent refraction or >3D of astigmatism); (e) concomitant ocular diseases, such as glaucoma or retinal detachment; (f) other genetic ocular diseases; and (g) other fundus diseases, including macular hiatus, macular edema, retinal vascular occlusion, or central serous chorioretinopathy.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200070
About this study
Official title: A Cross-sectional Study Exploring the Proteomic Association of Serum Extracellular Vesicles in Patients with Age-related Macular Degeneration and Cognitive Impairment Using LC-MS/MS
Aim: Preliminary serum exosomal proteomics of patients with dry age-related macular degeneration (AMD) and mild cognitive impairment (MCI) were analyzed using proteomics technology.
Methods: Peripheral serum samples were collected from patients with AMD, MCI, comorbid conditions, and the control group. Exosomes were isolated from these samples and analyzed using liquid chromatography-tandem mass spectrometry (LC-MS/MS). Differentially expressed proteins (DEPs) associated with the two diseases were identified based on fold change and p-value. DEPs were analyzed by Gene Ontology (GO) enrichment, Kyoto Encyclopedia of Genes and Genomes (KEGG), and protein-protein interaction (PPI) network analysis. Western blot and enzyme-linked immunosorbent assay (ELISA) were used to validate the DEPs of interest.
- Conditions
- Age Related Macular Degeneration, Mild Cognitive Impairment (MCI), Alzheimer's Disease (AD)
- Keywords
- Age-related macular degeneration, Mild cognitive impairment, Alzheimer's disease, Serum exosomes, liquid chromatography-tandem mass spectrometry (LC-MS/MS), Differentially expressed proteins
- Medical subject headings
- Macular Degeneration, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| AMD | patients with only dry age-related macular degeneration | |
| MCI | patients with only mild cognitive impairment | |
| control | patients with no mild cognitive impairment and no age-related macular degeneration | |
| comorbid | patients with both mild cognitive impairment and dry age-related macular degeneration |
What is being measured
The primary outcome is the main question the study is designed to answer.
MMSE
Mini-Mental State Examination
Measured: On the first day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start1 Apr 2019
- Primary completion3 Jun 2024
- Study completion3 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age Related Macular DegenerationStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 120 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sun Yilin, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06883461
- Sponsor's protocol ID
- SHSY-IEC-4.1/156/01
- Status last verified
- Mar 2025
- First submitted
- 13 Mar 2025
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- 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 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-sectional Study Exploring the Proteomic Association of Serum Extracellular Vesicles in Patients with Age-related Macular Degeneration and Cognitive Impairment Using LC-MS/MS
- ClinicalTrials.gov ID
- NCT06883461
- Acronym / sponsor ID
- SHSY-IEC-4.1/156/01
- Conditions
- Age Related Macular Degeneration, Mild Cognitive Impairment (MCI), Alzheimer's Disease (AD)
- Keywords
- Age-related macular degeneration, Mild cognitive impairment, Alzheimer's disease, Serum exosomes, liquid chromatography-tandem mass spectrometry (LC-MS/MS), Differentially expressed proteins
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 3 Jun 2024 (actual)
- Study completion
- 3 Jun 2024 (actual)
- First posted
- 19 Mar 2025 (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.
Aim: Preliminary serum exosomal proteomics of patients with dry age-related macular degeneration (AMD) and mild cognitive impairment (MCI) were analyzed using proteomics technology.
Methods: Peripheral serum samples were collected from patients with AMD, MCI, comorbid conditions, and the control group. Exosomes were isolated from these samples and analyzed using liquid chromatography-tandem mass spectrometry (LC-MS/MS). Differentially expressed proteins (DEPs) associated with the two diseases were identified based on fold change and p-value. DEPs were analyzed by Gene Ontology (GO) enrichment, Kyoto Encyclopedia of Genes and Genomes (KEGG), and protein-protein interaction (PPI) network analysis. Western blot and enzyme-linked immunosorbent assay (ELISA) were used to validate the DEPs of interest.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AMD | – | –patients with only dry age-related macular degeneration |
| MCI | – | –patients with only mild cognitive impairment |
| control | – | –patients with no mild cognitive impairment and no age-related macular degeneration |
| comorbid | – | –patients with both mild cognitive impairment and dry age-related macular degeneration |
Who may qualify
- Ages
- 40 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients who attended the Department of Ophthalmology or Department of Neurology of Shanghai Tenth People's Hospital affiliated with Tongji University School of Medicine
Key inclusion criteria (2 listed)
- All dry AMD patients were diagnosed based on the Clinical Classification of Age-Related Macular Degeneration issued by the American Academy of Ophthalmology.
- All patients with MCI meet the Petersen criteria, including memory impairment, no abnormal cognitive function, dementia, or some cognitive impairment in daily life. A Mini-Mental State Examination (MMSE) score ≥24 points and a Montreal Cognitive Assessment (MoCA) score between 18 and 25 points were required.
Key exclusion criteria (2 listed)
- The systemic physical exclusion criteria were as follows:(a) Metabolic syndromes such as diabetes or obesity;(b) Uncontrolled hypertension or hypotension;(c) Serious cardiac disease;(d) Neurological diseases, including Parkinson's disease, multiple sclerosis, or peripheral neuropathy;(e) Psychiatric diseases such as hallucinations or depressive disorders;(f) a history of brain injury, stroke, or substance abuse.
- The ocular exclusion criteria were as follows: (a) intraocular pressure(IOP) > 21 mmHg; (b) axial length(AL) > 25 mm or <22 mm; (c) anterior segment disease affecting fundus examination; (d) retinal pathologic changes associated with high myopia or serious refractive errors (>5D of spherical equivalent refraction or >3D of astigmatism); (e) concomitant ocular diseases, such as glaucoma or retinal detachment; (f) other genetic ocular diseases; and (g) other fundus diseases, including macular hiatus, macular edema, retinal vascular occlusion, or central serous chorioretinopathy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
MMSE
Time frame: On the first day
Mini-Mental State Examination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Age Related Macular Degeneration and Mild Cognitive Impairment (MCI), run by Shanghai 10th People's Hospital 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 2 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: finished, as of the sponsor's last update on 19 Mar 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MMSE (time frame: On the first day). 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 19 Mar 2025.