An observational study in Alzheimer Disease, Dementia Alzheimers and Dementia, sponsored by Universitaire Ziekenhuizen KU Leuven. Status unknown at 1 site in Belgium. Per ClinicalTrials.gov, last updated 2018-03-21.
Sponsored by Universitaire Ziekenhuizen KU Leuven · Observational
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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 2016, is one of 6 observational ones, and was the 3rd registered.
3,968 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 50–85
Universitaire Ziekenhuizen KU Leuven · Sites in Belgium
Ages 18+ · Healthy volunteers
By country, each count listing its studies:
Of the 643 Alzheimer Disease studies recruiting now, 284 (44%) set no upper age limit and 55 (9%) stop at 75 or younger; 34 take children under 18; 285 take healthy volunteers.
This study: all sexes · healthy volunteers too.
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 2016.
This study's planned enrollment of 85 is below 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.
In this observational study, the investigators aim to evaluate whether changes in the retinal and choroidal circulation, as assessed by Optical Coherence Tomography (OCT) and the quantification of retinal amyloid deposits using auto-fluorescence and hyperspectral retinal imaging, are correlated with the degree and subtype of dementia and with the presence or absence of a positive amyloid scan.
For this purpose, patients with established Alzheimer's Disease (AD) and Lewy Body Dementia (LBD), as well as amyloid positive and amyloid negative Mild Cognitive Impairment (MCI) and aged matched cognitively intact patients will be included in this cross-sectional study.
Being a direct extension of the central nervous system and the only place in the human body where the vessels of the central circulation can be visualized directly, the eye provides a unique window to investigate the central circulatory system. Several studies have demonstrated that retinal blood vessels show structural and functional alterations in patients with dementia. These measurements are based on fundus pictures and are hence limited to the larger retinal vessels.
Until recently, intravenous injection of a contrast agent was necessary to visualize the retinal microvasculature in detail. While indispensable for the diagnosis of some ocular vascular diseases (arterial/venous occlusion, neovascularization,...) the invasiveness of fluorescein angiography (and the risk of an allergic reaction) limits its use as a screening tool to detect alterations in the microvascular network of the retina and choroid.
Optical coherence tomography (OCT) is a non-invasive diagnostic tool capable of generating cross-sectional coupes of the retina and choroid. Novel algorithms allow to render a 3-dimensional model of the ocular microcirculation based merely on the motion contrast of the circulating blood. Since OCT is fast, easy to perform and completely non-invasive, this technique lends itself for screening purposes.
Auto-fluorescence retinal imaging is an imaging modality that is commonly used in ophthalmological practice to assess retinal pigment epithelium and photoreceptor function by quantifying the relative amount of auto-fluorescent lipofuscin. The images can be acquired using the OCT device but require pupil dilation. Using visible light of 488nm, it is a safe imaging technique with no short or late term side-effects to the patient. A recent study has described abnormal auto-fluorescence patterns in patients with cerebral amyloid deposition.
Hyperspectral fundus photography is comparable to regular fundus photography but uses an image sensor that can acquire images at multiple different wavelengths (unlike the classical red-green-blue colour sensors that are used in conventional cameras). Apart from a different image sensor, the device is identical to a regular fundus camera. Recent studies have emerged that describe a unique hyperspectral signature of aggregated retinal amyloid deposits.
The proposed study aims to investigate whether retinal or choroidal vascular parameters measured using OCT and the quantification of retinal amyloid deposits using auto-fluorescence and hyperspectral retinal imaging, could be useful to identify different subpopulations of cognitive intact, MCI and dementia patients.
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.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
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.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
amyloid-positive cognitively intact controls (55-80 years) interventions: non-invasive retinal imaging with Optical Coherence Tomography (OCT), OCT-angiography (OCT-A), Autofluorescence, Fundus Photography, Hyperspectral Imaging
Diagnostic Test: non-invasive retinal imaging
amyloid-negative cognitively intact controls (55-80 years) interventions: non-invasive retinal imaging with Optical Coherence Tomography (OCT), OCT-angiography (OCT-A), Autofluorescence, Fundus Photography, Hyperspectral Imaging
Diagnostic Test: non-invasive retinal imaging
amyloid-positive patients with Mild Cognitive Impairment interventions: non-invasive retinal imaging with Optical Coherence Tomography (OCT), OCT-angiography (OCT-A), Autofluorescence, Fundus Photography, Hyperspectral Imaging
Diagnostic Test: non-invasive retinal imaging
amyloid-negative patients with Mild Cognitive Impairment interventions: non-invasive retinal imaging with Optical Coherence Tomography (OCT), OCT-angiography (OCT-A), Autofluorescence, Fundus Photography, Hyperspectral Imaging
Diagnostic Test: non-invasive retinal imaging
patients in the dementia stage of Alzheimer's Disease interventions: non-invasive retinal imaging with Optical Coherence Tomography (OCT), OCT-angiography (OCT-A), Autofluorescence, Fundus Photography, Hyperspectral Imaging
Diagnostic Test: non-invasive retinal imaging
patients with Lewy Body Dementia interventions: non-invasive retinal imaging with Optical Coherence Tomography (OCT), OCT-angiography (OCT-A), Autofluorescence, Fundus Photography, Hyperspectral Imaging
Diagnostic Test: non-invasive retinal imaging
Diagnostic performance of OCT measurements in dementia
area under the curve (AUC) on receiver operating characteristic curves
Time frame: 2 years
Plan to share: Undecided
Started Mar 2016 (actual). Primary completion is estimated for Dec 2018, 33 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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