Fundus Camera Module for Early Detection of Alzheimer's Disease

NCT06841848 | Recruiting DMC

• 1 other identifier: CE/2023_023
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

• Validation of Multispectral Fundus Imaging for Alzheimer's Disease Detection

  Create an automatic AD detection model using advanced data processing, such as machine learning, that would be able to distinguish between AD and a healthy retina.

  Baseline

Study Arms (2)

Patients

Diagnostic Test: Fundoscopic Exam

Healthy Subjects

Diagnostic Test: Fundoscopic Exam

Interventions

Fundoscopic Exam DIAGNOSTIC_TEST

visualization of the retina using an ophthalmoscope

Healthy Subjects; Patients

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population is enrolled by Santa Lucia Foundation

You may qualify if:

• years or older
• Diagnosis:
• 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. If there are any doubts that the patient is mentally capable of giving informed consent, the patient will be examined and verified to be mentally capable by an independent physician/ neurologist, prior to the initiation of any study specific procedure

You may not qualify if:

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

Sponsors & Collaborators

• I.R.C.C.S. Fondazione Santa Lucia: lead

Study Sites (1)

Santa Lucia Foundation

Rome, Italy, 00179, Italy

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Ophthalmoscopy

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Ophthalmological; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Francesco Di Lorenzo, Dott

CONTACT

+390651501181; f.dilorenzo@hsantalucia.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2025
• First Posted: February 24, 2025
• Study Start: May 1, 2023
• Primary Completion: December 1, 2025
• Study Completion: March 1, 2026
• Last Updated: February 24, 2025

Record last verified: 2025-02

Locations

IT (1)