Using retinal imaging to detect and monitor Alzheimer's disease
Multimodal Retinal Imaging in the Detection and Follow-up of Alzheimer's Disease
This study is testing if looking at the eye can help find and track Alzheimer's disease in people aged 50 to 85.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 320 (estimated) |
| Ages | 50 Years to 85 Years |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 1 site (Leuven, Vlaams Brabant) |
| Trial ID | NCT03466177 on ClinicalTrials.gov |
What this trial studies
This observational study explores the potential of multimodal retinal imaging as a non-invasive method to detect and monitor Alzheimer's disease and related conditions. By examining the retina, which shares similarities with the brain, researchers aim to identify retinal biomarkers that could aid in early diagnosis and patient screening. The study focuses on individuals aged 50 to 85 and utilizes advanced imaging techniques to correlate retinal changes with cognitive impairment. The findings could provide insights into the pathophysiology of Alzheimer's and improve management strategies for the disease.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 50 to 85 who are fluent in Dutch and in stable medical condition.
Not a fit: Patients with a history of neurological disorders or significant strokes that could affect cognitive function may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier and more accurate diagnosis of Alzheimer's disease, improving patient outcomes.
How similar studies have performed: While the use of retinal imaging in neurodegenerative diseases is an emerging field, this specific approach is novel and has not been extensively tested in previous studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Between ≥ 50 and ≤ 85 years of age. * In the opinion of the investigator, the patient is in stable medical condition and willing and able to perform study procedures. * Patient is fluent in written and verbal Dutch. * Patient is capable of giving informed consent. Exclusion Criteria: * Patient has a history or current evidence of a neurological disorder, which, in the opinion of the primary investigator, may contribute to the subject's cognitive impairment. * Patient has a history of large-vessel stroke or evidence of a large-vessel infarction or other focal lesions on baseline MRI scan, which may contribute to the cause of the memory impairment in the opinion of the investigator. Vascular white matter lesions or other signs of microangiopathy will not be considered an exclusion. * Patient has a history of malignancy ≤ 5 years prior to signing informed consent, except for patients who have undergone potentially curative therapy with no evidence of recurrence for 1 year, and who are deemed at low risk for recurrency by her/his treating physician. * Patient is currently participating or has participated in a study with an investigational compound within 30 days of signing informed consent. * Subject has any magnetizable metal prostheses, implants or foreign objects that could pose a hazard during MRI scans. * Patient has a known history of ocular diseases other than the exception of cataract and/or wearing glasses/contact lenses.
Where this trial is running
Leuven, Vlaams Brabant
- UZ Leuven — Leuven, Vlaams Brabant, Belgium (Recruiting)
Study contacts
- Principal investigator: Ingeborg Stalmans, MD PhD — UZ Leuven/KU Leuven
- Study coordinator: Jan Van Eijgen, MD
- Email: jan.1.vaneijgen@uzleuven.be
- Phone: +3216332387
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.