CompletedNot Applicable

Association Between Age-related Macular Degeneration and Cognitive Impairment Based on Exosome Proteomics

China120 participantsStarted 2019-04-01

Plain-language 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. 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.

Who can participate

Age range

40 Years – 100 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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 sero…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This study is already completed and looked at a possible link between age-related macular degeneration and cognitive decline — has any of its findings changed how my doctor thinks about monitoring my memory or thinking skills alongside my eye care?
2Since the study used exosome proteomics — proteins found in tiny particles from blood or tissue — is there any chance those types of biomarker tests could become relevant to my own care in the near future, or are they still purely research tools?
3The trial measured cognitive function using something called the MMSE — is that a test my doctor could use to give me a baseline assessment now, so we can track any changes in my thinking over time given my AMD diagnosis?
4Given that this study focused on the connection between AMD and conditions like mild cognitive impairment and Alzheimer's disease, should I be proactively screened for early signs of cognitive impairment as part of my ongoing care?
5Are there any follow-up studies or clinical trials building on this research that my doctor thinks might be worth knowing about, especially ones that are still enrolling and that could be relevant to my situation?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

MMSE

Timeframe: On the first day

Trial details

NCT IDNCT06883461

SponsorShanghai 10th People's Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-06-03

View on ClinicalTrials.gov More Age Related Macular Degeneration trials