NCT06883461Completed
Association Between Age-related Macular Degeneration and Cognitive Impairment Based on Exosome Proteomics
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
Source: ClinicalTrials.gov · Last updated 19 Mar 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 120 (actual)
- First submitted
- 13 Mar 2025
- Start date
- 1 Apr 2019
- Primary completion date
- 3 Jun 2024
- Lead sponsor
- Shanghai 10th People's Hospital
- Diseases
- Macular degeneration, Alzheimer disease
- NCT number
- NCT06883461
What you commit to
- Study type: Observational
- Participants enrolled: 120
- From 1 Apr 2019 to the primary completion date, 3 Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Who the study is looking for
- 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.
Age in the registry: 40 years to 100 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Tenth People's Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.