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

NCT06883461 | Completed

• 1 other identifier: SHSY-IEC-4.1/156/01
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

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

Outcome Measures

Primary Outcomes (1)

• MMSE

  Mini-Mental State Examination

  On the first day

Study Arms (4)

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

Eligibility Criteria

• Age: 40 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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.

Sponsors & Collaborators

• Shanghai 10th People's Hospital: lead

Study Sites (1)

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, 200070, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

MeSH Terms

Conditions

Macular Degeneration; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Training physician

Study Record Dates

• First Submitted: March 13, 2025
• First Posted: March 19, 2025
• Study Start: April 1, 2019
• Primary Completion: June 3, 2024
• Study Completion: June 3, 2024
• Last Updated: March 19, 2025

Record last verified: 2025-03

Locations

CN (1)