Fundus Camera Module for Early Detection of Alzheimer's Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-01

Study Completion Date

2026-03-31

Brief Summary

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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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Detailed Description

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Conditions

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Alzheimer Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Patients

Fundoscopic Exam

Intervention Type DIAGNOSTIC_TEST

visualization of the retina using an ophthalmoscope

Healthy Subjects

Fundoscopic Exam

Intervention Type DIAGNOSTIC_TEST

visualization of the retina using an ophthalmoscope

Interventions

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Fundoscopic Exam

visualization of the retina using an ophthalmoscope

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes