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Fundus Camera Module for Early Detection of Alzheimer's Disease

Fundus Camera Module for Early Detection of Alzheimer's Disease

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06841848
Enrollment
80
Registered
2025-02-24
Start date
2023-05-01
Completion date
2026-03-31
Last updated
2025-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease

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.

Interventions

DIAGNOSTIC_TESTFundoscopic Exam

visualization of the retina using an ophthalmoscope

Sponsors

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

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Validation of Multispectral Fundus Imaging for Alzheimer's Disease DetectionBaselineCreate 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.

Countries

Italy

Contacts

Primary ContactFrancesco Di Lorenzo, Dott
f.dilorenzo@hsantalucia.it+390651501181

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026