Device for early detection of Alzheimer's disease using eye imaging
Fundus Camera Module for Early Detection of Alzheimer's Disease
I.R.C.C.S. Fondazione Santa Lucia · NCT06841848
This study is testing a new eye imaging device to see if it can help detect Alzheimer's disease early in people aged 55 and older.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 55 Years and up |
| Sex | All |
| Sponsor | I.R.C.C.S. Fondazione Santa Lucia (other) |
| Locations | 1 site (Rome, Italy) |
| Trial ID | NCT06841848 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 55 and older, either diagnosed with mild to moderate Alzheimer's disease or without any neurodegenerative disorders.
Not a fit: Patients with severe cognitive impairment that prevents cooperation during the imaging process will not benefit from this study.
Why it matters
Potential benefit: If successful, this device could enable earlier detection of Alzheimer's disease, leading to improved treatment options and better patient outcomes.
How similar studies have performed: While the approach of using eye imaging for early detection of Alzheimer's is innovative, similar studies have shown promise in identifying neurodegenerative conditions through ocular assessments.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Rome, Italy
- Santa Lucia Foundation — Rome, Italy, Italy (RECRUITING)
Study contacts
- Study coordinator: Francesco Di Lorenzo, Dott
- Email: f.dilorenzo@hsantalucia.it
- Phone: +390651501181
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Alzheimer Disease