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

NCT03466177 | Unknown

• 1 other identifier: S60932
• Study Type: observational
• Target: 320
• Locations: 1 country
• Sites: 1

Brief Summary

Because of a shared ontogenic origin, the retina displays similarities to the brain and spinal cord in terms of anatomy, functionality, response to insult, and immunology. Hence, the retina can be approached as an integral part of the central nervous system. The occurence of ocular manifestations in several neurodegenerative pathologies, such as Alzheimer's disease and Parkinson's disease, accentuates the strong relationship between eye and brain. Particularly retinal changes can present a substrate for cerebral changes in these disorders. Offering a 'window to the brain', the transparent eye enables non-invasive imaging of these changes in retinal structure and vasculature. In this project, the potential of retinal biomarkers for e.g. Alzheimer's will be explored with the aim to overcome some of the hurdles in the current management of these pathologies, mainly the lack of techniques for patient screening and early diagnosis. The aim of this clinical trial is to correlate the retinal biomarkers for Alzheimer's with neuro-imaging, and cognitive function. Integrating the results will yield non-invasive retinal biomarkers for clinical research, screening, and follow-up of disease progression in various neurodegenerative disorders.

Conditions

Alzheimer Disease; Alzheimer Dementia; Mild Cognitive Impairment; Dementia; Glaucoma; Age-Related Macular Degeneration; Diabetic Retinopathy

Keywords

Alzheimer's disease; Dementia; Mild cognitive impairment; Optical coherence tomography; Hyperspectral imaging; Multimodal retinal imaging

Outcome Measures

Primary Outcomes (5)

• Retinal biomarkers for AD: specificity

  To evaluate the diagnostic performance of selected ocular biomarkers for Alzheimer's disease

  5 years

• Retinal biomarkers for AD: sensitivity

  To evaluate the diagnostic performance of selected ocular biomarkers for Alzheimer's disease

  5 years

• Retinal biomarkers for AD: number needed to image

  To evaluate the diagnostic performance of selected ocular biomarkers for Alzheimer's disease

  5 years

• Retinal biomarkers for AD: area under the curve (AUC)

  To evaluate the diagnostic performance of selected ocular biomarkers for Alzheimer's disease

  5 years

• Retinal biomarkers for AD: receiver operating characteristic (ROC)

  To evaluate the diagnostic performance of selected ocular biomarkers for Alzheimer's disease

  5 years

Secondary Outcomes (2)

• Retinal biomarkers for AD: quantification of cerebral Aβ load by non-invasive retinal imaging against the cerebral Aβ load measured by cerebral imaging

  15 years

• Retinal biomarkers for AD: disease progression by measuring the change from baseline at 2 years and more

  15 years

Study Arms (7)

Ab+ AD patients

amyloid positive Alzheimer's Disease patients \- Ocular examination Visual acuity, biomicroscopy, funduscopy Fundus pictures, including hyperspectral imaging OCT + angio-OCT (Non-invasive, multimodal retinal imaging), Dynamic Vessel Analyzer (DVA)

Diagnostic Test: Non-invasive, multimodal retinal imaging

Ab+ Mild Cognitive Impairment (MCI) patients

amyloid positive Mild Cognitive Impairment patients \- Ocular examination Visual acuity, biomicroscopy, funduscopy Fundus pictures, including hyperspectral imaging OCT + angio-OCT (Non-invasive, multimodal retinal imaging), Dynamic Vessel Analyzer (DVA)

Diagnostic Test: Non-invasive, multimodal retinal imaging

Ab+ cognitively intact volunteers

amyloid positive cognitively intact volunteers \- Ocular examination Visual acuity, biomicroscopy, funduscopy Fundus pictures, including hyperspectral imaging OCT + angio-OCT (Non-invasive, multimodal retinal imaging), Dynamic Vessel Analyzer (DVA)

Diagnostic Test: Non-invasive, multimodal retinal imaging

Ab- cognitively intact volunteers

amyloid negative cognitively intact volunteers \- Ocular examination Visual acuity, biomicroscopy, funduscopy Fundus pictures, including hyperspectral imaging OCT + angio-OCT (Non-invasive, multimodal retinal imaging), Dynamic Vessel Analyzer (DVA)

Diagnostic Test: Non-invasive, multimodal retinal imaging

Glaucoma patients

\- Ocular examination Visual acuity, biomicroscopy, funduscopy Fundus pictures, including hyperspectral imaging OCT + angio-OCT (Non-invasive, multimodal retinal imaging), Dynamic Vessel Analyzer (DVA)

Diagnostic Test: Non-invasive, multimodal retinal imaging

Age-related macular degeneration patients

\- Ocular examination Visual acuity, biomicroscopy, funduscopy Fundus pictures, including hyperspectral imaging OCT + angio-OCT (Non-invasive, multimodal retinal imaging), Dynamic Vessel Analyzer (DVA)

Diagnostic Test: Non-invasive, multimodal retinal imaging

Diabetic retinopathy patients

\- Ocular examination Visual acuity, biomicroscopy, funduscopy Fundus pictures, including hyperspectral imaging OCT + angio-OCT (Non-invasive, multimodal retinal imaging), DVA

Diagnostic Test: Non-invasive, multimodal retinal imaging

Interventions

Non-invasive, multimodal retinal imaging DIAGNOSTIC_TEST

Ocular exam including the application of different non-invasive ocular imaging techniques

Ab+ AD patients; Ab+ Mild Cognitive Impairment (MCI) patients; Ab+ cognitively intact volunteers; Ab- cognitively intact volunteers; Age-related macular degeneration patients; Diabetic retinopathy patients; Glaucoma patients

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Cfr. eligibility criteria

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, Vlaams Brabant, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction; Dementia; Glaucoma; Macular Degeneration; Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders; Ocular Hypertension; Eye Diseases; Retinal Degeneration; Retinal Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Ingeborg Stalmans, MD PhD

  UZ Leuven/KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jan Van Eijgen, MD

CONTACT

+3216332387; jan.1.vaneijgen@uzleuven.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2018
• First Posted: March 15, 2018
• Study Start: March 1, 2018
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: October 10, 2023

Record last verified: 2023-10

Locations

BE (1)