Fundus Camera Module for Early Detection of Alzheimer's Disease

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

Status

Enrolling

Conditions

Alzheimer Disease

Treatments

Diagnostic Test: Fundoscopic Exam

Study type

Observational

Funder types

Other

Identifiers

NCT06841848

CE/2023_023

Details and patient eligibility

About

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.

Enrollment

80 estimated patients

Sex

All

Ages

55+ years old

Volunteers

Accepts Healthy Volunteers

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.