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Search / Trial NCT03466177

Multimodal Retinal Imaging in the Detection and Follow-up of Alzheimer's Disease

Launched by UNIVERSITAIRE ZIEKENHUIZEN KU LEUVEN · Mar 7, 2018

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Alzheimer's Disease Dementia Mild Cognitive Impairment Optical Coherence Tomography Hyperspectral Imaging Multimodal Retinal Imaging

ClinConnect Summary

This clinical trial is studying how changes in the retina, the light-sensitive layer at the back of the eye, may help identify and monitor Alzheimer's disease and other related conditions. Researchers believe that the retina can provide important clues about the health of the brain, similar to how brain scans work. By examining these retinal changes, the study aims to develop non-invasive methods for early diagnosis and tracking the progression of Alzheimer's and similar neurodegenerative diseases.

To participate in this trial, individuals must be between 50 and 85 years old, in stable health, and able to understand and communicate in Dutch. Participants will undergo various imaging tests to look at their eyes and brain, and they should expect a supportive environment where their contributions could lead to better ways to diagnose and manage Alzheimer's disease. It's important to note that some individuals may not be eligible if they have certain neurological disorders, recent strokes, or specific eye conditions, among other criteria.

Gender

ALL

Eligibility 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.

About Universitaire Ziekenhuizen Ku Leuven

Universitaire Ziekenhuizen KU Leuven is a leading academic medical center in Belgium, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. Affiliated with KU Leuven, one of Europe’s premier universities, the institution integrates cutting-edge scientific inquiry with high-quality patient care. It plays a pivotal role in the development and implementation of clinical trials, fostering collaboration between researchers, healthcare professionals, and industry partners to translate scientific discoveries into effective treatments. The hospital's multidisciplinary approach ensures comprehensive patient safety and ethical standards, positioning it as a trusted sponsor in the realm of clinical research.

Locations

Leuven, , Belgium

Patients applied

0 patients applied

Trial Officials

Ingeborg Stalmans, MD PhD

Principal Investigator

UZ Leuven/KU Leuven

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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