Actively Recruiting

Age: 55Years +
All Genders
Healthy Volunteers
NCT06841848

Fundus Camera Module for Early Detection of Alzheimer's Disease

Led by I.R.C.C.S. Fondazione Santa Lucia · Updated on 2025-02-24

80

Participants Needed

1

Research Sites

147 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Alzheimer's Disease (AD) affects tens of millions of people just in Europe. It is typically detected in its late stage when irreversible damage has already occurred, and current treatments are mostly conservative or palliative. Here we developed a device performing high-resolution multispectral imaging of the eye fundus to detect AD in its early stage. After clinical testing, the proposed device has a high potential to become a method for routine population screening, as it is non-invasive and affordable. The possibility of AD detection in an early stage is crucial for developing a new pharmaceutical treatment that would dramatically improve the lives of millions and save the expenses connected to lifelong healthcare assistance to people with AD in later stages.

CONDITIONS

Official Title

Fundus Camera Module for Early Detection of Alzheimer's Disease

Who Can Participate

Age: 55Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 55 years or older
  • For AD group: Clinically diagnosed with Alzheimer's disease (mild to moderate stage) based on Mini-Mental State Examination (MMSE) score between 10-26 and confirmed by PET imaging or CSF
  • For Control group: No diagnosis of Alzheimer's disease or other neurodegenerative disorders
  • Signed informed consent by the patient, with mental capability verified if there is any doubt
Not Eligible

You will not qualify if you...

  • Severe cognitive impairment (MMSE <10) preventing cooperation during the imaging process
  • Inability to remain still during the fundus imaging procedure

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Santa Lucia Foundation

Rome, Italy, Italy, 00179

Actively Recruiting

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Research Team

F

Francesco Di Lorenzo, Dott

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Fundus Camera Module for Early Detection of Alzheimer's Disease | DecenTrialz