Optical Coherence Tomography in Cerebral Amyloidosis

NCT03472482 | Unknown

• 1 other identifier: S59048
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alzheimer Disease; Dementia Alzheimers; Dementia; Lewy Body Disease; Dementia, Lewy Body; Mild Cognitive Impairment

Keywords

Alzheimer's disease; Dementia; Lewy body disease; Retina; Retinal imaging; Optical Coherence Tomography; Hyperspectral imaging; Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• Diagnostic performance of OCT measurements in dementia

  area under the curve (AUC) on receiver operating characteristic curves

  2 years

Study Arms (6)

Ab+ cognitively intact volunteers

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

Ab- cognitively intact volunteers

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 MCI patients

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 MCI patients

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

AD patients

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

LBD patients

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

Interventions

non-invasive retinal imaging DIAGNOSTIC_TEST

AD patients; Ab+ cognitively intact volunteers; Ab- cognitively intact volunteers; LBD patients; amyloid-negative MCI patients; amyloid-positive MCI patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Cfr. Eligibility Criteria

You may qualify if:

• Cognitively intact healthy controls will be recruited from an ongoing community-recruited longitudinal cohort of cognitively intact older adults (55-85 years, S51125) who all have undergone amyloid Positron Emission Tomography (PET) at the baseline visit in the context of study S51125. Half of the subjects will be amyloid-positive and half will be amyloid-negative. In the context of study S51125 these subjects receive two-yearly neuropsychological assessment.
• MCI patients (Petersen et al., 2004 criteria) will be recruited from an ongoing memory-clinic recruited longitudinal cohort of patients with amnestic mild cognitive impairment who participate in study S55892. All subjects have undergone an amyloid PET at the baseline study in the context of study S55892. Half of the subjects will be amyloid-positive and half will be amyloid negative.
• Clinically probable AD subjects (National Institute of Neurological Disorders and Stroke (NINDS) and the Association Internationale pour la Recherche et l'Enseignement en Neurosciences (AIREN) criteria) will be recruited from the memory clinic University Hospitals Leuven (MMSE 12-28). Subjects will be recruited only if they are capable of providing written informed consent.
• Clinically probable LBD (McKeith et al. criteria, 2005) will be recruited from the memory clinic University Hospitals Leuven (MMSE 12-28). Subjects will be recruited only if they are capable of providing written informed consent.
• Capable and willing to participate

You may not qualify if:

• Personal medical history of retinal neovascularization
• Unable or unwilling to give consent

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease; Dementia; Lewy Body Disease; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Cognition Disorders

Study Officials

• Evelien Vandewalle, MD PhD

  UZ Leuven/KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karel Van Keer, MD

CONTACT

+3216332387; karel.vankeer@uzleuven.be

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2018
• First Posted: March 21, 2018
• Study Start: March 25, 2016
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2019
• Last Updated: March 21, 2018

Record last verified: 2018-01

Locations

BE (1)