NCT06841848 Fundus Camera Module for Early Detection of Alzheimer's Disease
| NCT ID | NCT06841848 |
| Status | Recruiting |
| Phase | — |
| Sponsor | I.R.C.C.S. Fondazione Santa Lucia |
| Condition | Alzheimer Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 80 participants |
| Start Date | 2023-05-01 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 80 participants in total. It began in 2023-05-01 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06841848 clinical trial?
This trial is open to participants of all sexes, aged 55 Years or older, studying Alzheimer Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06841848 currently recruiting?
Yes, NCT06841848 is actively recruiting participants. Contact the research team at f.dilorenzo@hsantalucia.it for enrollment information.
Where is the NCT06841848 trial being conducted?
This trial is being conducted at Rome, Italy.
Who is sponsoring the NCT06841848 clinical trial?
NCT06841848 is sponsored by I.R.C.C.S. Fondazione Santa Lucia. The trial plans to enroll 80 participants.
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