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NCT Number: NCT06841848

Fundus Camera Module for Early Detection of Alzheimer's Disease

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.

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

55 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Santa Lucia Foundation

Rome, Italy, 00179

Location status: Recruiting

Location contact

Francesco Di Lorenzo, Dott

CONTACT

[email protected]

+390651501181

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 55 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

Exclusion criteria

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

Treatment and study plan

Fundoscopic Exam

Diagnostic Test

visualization of the retina using an ophthalmoscope

Primary outcomes

  1. Validation of Multispectral Fundus Imaging for Alzheimer's Disease Detection

    Time frame: Baseline

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Francesco Di Lorenzo, Dott

CONTACT

[email protected]

+390651501181

Sponsors and collaborators

Lead sponsor

I.R.C.C.S. Fondazione Santa Lucia

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Feb 24, 2025
Registry last updated
Feb 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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