Device for early detection of Alzheimer's disease using eye imaging

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate a novel device that utilizes high-resolution multispectral imaging of the eye fundus to detect Alzheimer's disease (AD) at an early stage. The device is designed to be non-invasive and affordable, making it suitable for routine population screening. Participants will include individuals aged 55 and older, with either a diagnosis of mild to moderate AD or no neurodegenerative disorders. The study seeks to establish the effectiveness of this imaging technique in identifying AD before significant cognitive decline occurs.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 55 years or older
* Diagnosis:

  1. 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.
  2. 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.

Where it's running

• Santa Lucia Foundation
  Rome, Italy, Italy Recruiting

Study contacts

• Study coordinator: Francesco Di Lorenzo, Dott
• Email: f.dilorenzo@hsantalucia.it
• Phone: +390651501181

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.