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

NCT ID: NCT06883461

Last Updated: 2025-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-01

Study Completion Date

2024-06-03

Brief Summary

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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.

Detailed Description

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Conditions

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Age Related Macular Degeneration Mild Cognitive Impairment (MCI) Alzheimer's Disease (AD)

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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AMD

patients with only dry age-related macular degeneration

No interventions assigned to this group

MCI

patients with only mild cognitive impairment

No interventions assigned to this group

control

patients with no mild cognitive impairment and no age-related macular degeneration

No interventions assigned to this group

comorbid

patients with both mild cognitive impairment and dry age-related macular degeneration

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shanghai 10th People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Sun Yilin

Training physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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SHSY-IEC-4.1/156/01

Identifier Type: -

Identifier Source: org_study_id

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