Retinal Neuro-vascular Coupling in Patients With Neurodegenerative Disease
1 other identifier
interventional
150
1 country
1
Brief Summary
Alzheimer´s disease (AD) in one of the most important causes of dementia and poses a considerable challenge in health care. Today, criteria for the diagnosis and the follow up of patients with AD mainly rely either on subjective tests or invasive methods. This limits the general applicability of the latter test for population screening and underlines the need for the identification of easily accessible tools for the identification of high-risk subjects. Because of its unique optical properties, the eye offers the possibility of the non-invasive assessment of both structural and functional alterations in neuronal tissue. As the neuro-retina is part of the brain, it does not come as a surprise that neuro-degenerative changes in the brain are accompanied by structural and possibly also functional changes in the neuro-retina and the ocular vasculature. The current study seeks to test the hypothesis that beside the known anatomical changes, also functional changes can be detected in the retina of patients with AD. For this purpose, flicker light induced hyperemia will be measured in the retina as a functional test to assess the coupling between neural activity and blood flow. Further, structural parameters such as retinal nerve fiber layer thickness and function parameters such as ocular blood flow and retinal oxygenation will be assessed and compared to age and sex matched controls.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 21, 2015
CompletedFirst Posted
Study publicly available on registry
January 26, 2016
CompletedStudy Start
First participant enrolled
September 27, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2023
CompletedApril 7, 2022
April 1, 2022
6.9 years
December 21, 2015
April 6, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Flicker induced increase in retinal blood flow
1 day
Study Arms (3)
Mild cognitive impairment
EXPERIMENTALPatients with mild cognitive impairment
Alzheimer Disease
EXPERIMENTALPatients with Alzheimer Disease
Healthy
EXPERIMENTALHealthy volunteers
Interventions
Eligibility Criteria
You may qualify if:
- Men and women aged over 50 years
- Non-smokers
- Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant
- Normal ophthalmic findings, ametropia \< 6 Dpt
- Men and women aged over 50 years
- Normal ophthalmic findings, ametropia \< 6 Dpt.
- Confirmed diagnosis of probable AD of mild to moderate degree defined as:
- Diagnosis of probable Alzheimer's disease based on the NINCDS/ADRDA criteria
- Assessing the severity of Alzheimer's disease of mild to moderate degree by the Mini Mental State Examination (MMSE). AD of mild to moderate degree has been confirmed if the MMSE score is in the range of 20 to 26 inclusive
- Hachinski Ischemia Scale is used to try and distinguish AD from multi-infarct dementia. A score of ≤ 4 suggests AD Informed consent capability
- Adequate visual and auditory acuity to allow neuropsychological testing and participation in the ocular blood flow measurements
- Men and women aged over 50 years
- Normal ophthalmic findings, ametropia \< 6 Dpt.
- Diagnosis of probable mild cognitive impairment (MCI) defined as:
- memory complaint, corroborated by an informant
- +6 more criteria
You may not qualify if:
- Presence or history of a severe medical condition other than cognitive impairment as judged by the clinical investigator
- Untreated Arterial hypertension
- History or family history of epilepsy
- Presence of any abnormalities preventing reliable measurements in the study eye as judged by the investigator
- Best corrected visual acuity \< 0.5 Snellen
- Ametropia greater than 6 Dpt
- pregnancy or planned pregnancy
- Major psychiatric disorder (e.g. schizophrenia), if considered relevant by the investigator
- Significant neurological disease other than AD or MCI, if considered relevant by the investigator
- Alcoholism or substance abuse
- Presence or history of a severe medical condition as judged by the clinical investigator
- Untreated Arterial hypertension
- History or family history of epilepsy
- Presence of any abnormalities preventing reliable measurements in the study eye as judged by the investigator
- Family history of AD
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, 1090, Austria
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gerhard Garhöfer, MD
Department of Clinical Pharmacology, Medical University of Vienna
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assoc. Prof. PD Dr.
Study Record Dates
First Submitted
December 21, 2015
First Posted
January 26, 2016
Study Start
September 27, 2016
Primary Completion
September 1, 2023
Study Completion
September 30, 2023
Last Updated
April 7, 2022
Record last verified: 2022-04