An observational study in Alzheimer Disease, Alzheimer Dementia and Mild Cognitive Impairment, sponsored by Universitaire Ziekenhuizen KU Leuven. Recruiting at 1 site in Belgium. Open to participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-10-10.
Sponsored by Universitaire Ziekenhuizen KU Leuven · Observational
Among 10 studies in Alzheimer Disease by Universitaire Ziekenhuizen KU Leuven — 5 open to participants now, 5 under way, none of them phase 3. Alzheimer Disease · Universitaire Ziekenhuizen KU Leuven.
Among the 10 studies in Alzheimer Disease by Universitaire Ziekenhuizen KU Leuven, this one is the only one that started in 2018, is one of 6 observational ones, and was the 4th registered.
3,967 studies on the registry are indexed under Alzheimer Disease; 928 are open to participants now.
Browse Alzheimer Disease studies →5 of the 10 studies in Alzheimer Disease by Universitaire Ziekenhuizen KU Leuven are open now, in 1 country. Recruiting first, the newest first:
Universitaire Ziekenhuizen KU Leuven · Sites in Belgium
Ages 55–85 · Healthy volunteers
Universitaire Ziekenhuizen KU Leuven · Sites in Belgium
Ages 18–90 · Healthy volunteers
Universitaire Ziekenhuizen KU Leuven · Sites in Belgium
Ages 18–70 · Healthy volunteers
Universitaire Ziekenhuizen KU Leuven · Sites in Belgium
Ages 18+ · Healthy volunteers
By country, each count listing its studies:
Of the 642 Alzheimer Disease studies recruiting now, 283 (44%) set no upper age limit and 55 (9%) stop at 75 or younger; 34 take children under 18; 284 take healthy volunteers.
This study: 50 Years to 85 Years · all sexes.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
10 studies; the count open now beside each. This study's row is marked.
First in 2012; this study’s year is marked. 1 started in 2018.
This study's planned enrollment of 320 is above the median of 200 across 815 observational studies indexed under Alzheimer Disease.
Median enrollment 159 across the 4 interventional studies, 78 across the 6 observational. Of the 2 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 963 studies on the registry; 267 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 10 studies in Alzheimer Disease by Universitaire Ziekenhuizen KU Leuven, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Alzheimer's disease (AD) is the most common neurodegenerative disorder and the leading cause of dementia worldwide. A growing number of people are surviving into their 80s-90s and the number of AD patients projected to nearly triple in the next three decades, affecting 80-90 million people worldwide by 2040. As such, AD will become the third cause of death for older people, just behind cardiovascular disease and cancer. In contrast to the latter, AD cannot be prevented, slowed or cured. AD represents an enormous socio-economic burden and has become a trillion dollar disease. Despite decades of intensive research, diagnosis and treatment remain challenging for AD. A string of recent failures in clinical trials for AD drugs has pointed out that our understanding of the disease is still far from complete. More in detail, three major reasons underlying this treatment gap have been identified:
i. The lack of techniques for patient screening and early diagnosis. ii. The incomplete understanding of the complex interplay of pathological processes that underlie AD.
iii. The many hurdles between drug discovery and approval.
With this study, the investigators propose a novel way to address these needs, by using the retina as a model organ to study the central nervous system (CNS). Many of the hallmark cerebral pathophysiological processes of AD have also been observed in the retina. Unlike the rest of the CNS, the retina can be visualized directly, with an imaging resolution up to 100x higher than PET and MRI scans. Using these high-resolution imaging tools such as Optical Coherence Tomography (OCT), studies have demonstrated microvascular changes and neuro-retinal thinning in AD patients. Pilot data show that retinal Aβ can be visualized non-invasively solely based on the intrinsic hyperspectral signature of aggregated amyloid deposits. Non-invasive retinal imaging (e.g., fundus photography, OCT, hyperspectral imaging (HSI)) - which are all available at affordable cost -, could therefore represent novel means for identifying patients at risk, for longitudinal follow-up of disease progression in AD patients, and for research in a quest for more effective treatments.
This is an open-label longitudinal biomarker study without investigational medicinal product in subjects in different stages of the AD spectrum.
The data that we will collect consist of amyloid imaging, MRI, blood, genetic, general health and cognitive data, as well as visual acuity, ocular biomicroscopy and funduscopy, fundus photographs, hyperspectral retinal images, Optical Coherence Tomography (OCT) retinal images and OCT angiography (OCT-A) retinal images. Subjects will be followed longitudinally. In the current study the investigators will primarily investigate the potential of non-invasive, multimodal retinal imaging for the early detection of Alzheimer's disease and for the evaluation of disease progression. This will be done in comparison with amyloid imaging and neuropsychological evaluations.
The investigators will build a longitudinal database of ocular, systemic, neuro-psychiatric, MRI and PET imaging parameters of Aβ-positive and Aβ-negative patients with different stages of cognitive impairment. This database will be used to provide proof-of-concept that retinal biomarkers provide an early, accurate and non-invasive tool for AD detection and follow-up. All data will be collected in a database for statistical analysis.
Cfr. eligibility criteria
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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
- 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
- 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
- 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
Ocular exam including the application of different non-invasive ocular imaging techniques
Retinal biomarkers for AD: specificity
To evaluate the diagnostic performance of selected ocular biomarkers for Alzheimer's disease
Time frame: 5 years
Retinal biomarkers for AD: sensitivity
To evaluate the diagnostic performance of selected ocular biomarkers for Alzheimer's disease
Time frame: 5 years
Retinal biomarkers for AD: number needed to image
To evaluate the diagnostic performance of selected ocular biomarkers for Alzheimer's disease
Time frame: 5 years
Retinal biomarkers for AD: area under the curve (AUC)
To evaluate the diagnostic performance of selected ocular biomarkers for Alzheimer's disease
Time frame: 5 years
Retinal biomarkers for AD: receiver operating characteristic (ROC)
To evaluate the diagnostic performance of selected ocular biomarkers for Alzheimer's disease
Time frame: 5 years
Retinal biomarkers for AD: quantification of cerebral Aβ load by non-invasive retinal imaging against the cerebral Aβ load measured by cerebral imaging
To deliver a proof-of-concept for the use of retinal biomarkers to quantitatively measure cerebral Aβ load by comparing the results of cerebral imaging (Standard Uptake Value ratio (SUVr) on amyloid-PET) with the results of retinal hyperspectral imaging (area of retinal Aβ detected, in µm²)
Time frame: 15 years
Retinal biomarkers for AD: disease progression by measuring the change from baseline at 2 years and more
To deliver a proof-of-concept for the use of retinal biomarkers to follow Alzheimer's disease progression by measuring the change from baseline at 2 years and after and to compare the results of the cerebral imaging and neuropsychiatric tests with the results from the selected retinal biomarkers for AD at different time points (t0, t 6 months, t 12 months, t 18 months, t 24 months, yearly for 15y)
Time frame: 15 years
Plan to share: Undecided
Started Mar 2018 (actual). Primary completion is estimated for Dec 2024, 81 months after the start.
Of 364 non-industry observational studies under Alzheimer Disease, half reached primary completion within 81 months of starting (the median), counting those still running; a quarter within 39 and three quarters within 203. This study's planned 81 months is close to that.
Counting every sponsor, half of 405 studies reached it within 67 months; a quarter within 35 and three quarters within 171.
How these figures are worked out, and which studies are left out of them.
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