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

Last updated: March 13, 2025
Sponsor: Shanghai 10th People's Hospital
Overall Status: Completed

Phase

N/A

Condition

Memory Loss

Memory Problems

Mild Cognitive Impairment

Treatment

N/A

Clinical Study ID

NCT06883461
SHSY-IEC-4.1/156/01
  • Ages 40-100
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • All dry AMD patients were diagnosed based on the Clinical Classification ofAge-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

Exclusion Criteria:

  • The systemic physical exclusion criteria were as follows:(a) Metabolic syndromessuch as diabetes or obesity;(b) Uncontrolled hypertension or hypotension;(c) Seriouscardiac disease;(d) Neurological diseases, including Parkinson's disease, multiplesclerosis, or peripheral neuropathy;(e) Psychiatric diseases such as hallucinationsor 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.

Study Design

Total Participants: 120
Study Start date:
April 01, 2019
Estimated Completion Date:
June 03, 2024

Connect with a study center

  • Shanghai Tenth People's Hospital

    Shanghai, Shanghai 200070
    China

    Site Not Available

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