Fundus Camera Module for Early Detection of Alzheimer's Disease

Last updated: February 21, 2025
Sponsor: I.R.C.C.S. Fondazione Santa Lucia
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Fundoscopic Exam

Clinical Study ID

NCT06841848
CE/2023_023
  • Ages > 55
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 55 years or older

  • Diagnosis:

  1. For AD group: Clinically diagnosed with Alzheimer's disease (mild to moderatestage) based on Mini-Mental State Examination (MMSE) score between 10-26 andconfirmed by PET imaging or CSF.

  2. For Control group: No diagnosis of Alzheimer's disease or otherneurodegenerative disorders.

  • Signed informed consent by the patient. If there are any doubts that the patient ismentally capable of giving informed consent, the patient will be examined andverified to be mentally capable by an independent physician/ neurologist, prior tothe initiation of any study specific procedure

Exclusion

Exclusion Criteria:

  • Severe cognitive impairment (MMSE <10) preventing cooperation during the imagingprocess.

  • Inability to remain still during the fundus imaging procedure.

Study Design

Total Participants: 80
Treatment Group(s): 1
Primary Treatment: Fundoscopic Exam
Phase:
Study Start date:
May 01, 2023
Estimated Completion Date:
March 31, 2026

Connect with a study center

  • Santa Lucia Foundation

    Rome, 00179
    Italy

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.