Fundus Camera Module for Early Detection of Alzheimer's Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fundoscopic Exam.
- Who it may be relevant to
- Registry conditions: Alzheimer Disease. Basic parameters: from 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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 test Fundoscopic Exam
visualization of the retina using an ophthalmoscope
Primary outcome measures
- Validation of Multispectral Fundus Imaging for Alzheimer's Disease Detection [Time frame: Baseline]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Italy · 1 center
- Santa Lucia Foundation — Rome
Identifiers
NCT: NCT06841848 · CE/2023_023