- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02663531
Retinal Neuro-vascular Coupling in Patients With Neurodegenerative Disease
April 6, 2022 updated by: Gerhard Garhofer, Medical University of Vienna
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
150
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Gerhard Garhöfer, MD
- Phone Number: 29810 0043140400
- Email: gerhard.garhoefer@medunwien.ac.at
Study Locations
-
-
-
Vienna, Austria, 1090
- Recruiting
- Department of Clinical Pharmacology, Medical University of Vienna
-
Principal Investigator:
- Gerhard Garhöfer, MD
-
Contact:
- Gerhard Garhöfer, MD
- Phone Number: 29810 +43 (1) 40400
- Email: gerhard.garhoefer@meduniwien.ac.at
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
Inclusion criteria for healthy subjects
- 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
Inclusion criteria for patients with AD:
- 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
- A potential participant has to be on stable doses of all medications he/she is taking because of consisting illnesses according to medical history (except AD therapy itself which will be recorded separately) for at least 30 days prior inclusion, if considered relevant by the investigator.
Inclusion criteria for patients with mild cognitive impairment:
- 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
- abnormal memory function, documented by delayed recall of one paragraph from the Logical Memory II subtest of the Wechsler Memory Scale-Revised (cutoff scores: ≤8 for ≥16 years of education; ≤4 for 8 to 15 years of education; and ≤2 for 0 to 7 years of education [the maximum number of paragraph items possible to correctly recall is 25])
- normal general cognitive function, as determined by a clinician's judgment based on a structured interview with the patient and an informant (Clinical Dementia Rating [CDR]) and a Mini-Mental State Examination (MMSE) score greater than 26
- no or minimal impairment in activities of daily living (ADLs), as determined by a clinical interview with the patient and informant
- not sufficiently impaired, cognitively and functionally, to meet the NINCDS/ADRDA criteria, as judged by an experienced AD research clinician
- Hachinski Ischemia Scale is used to try and distinguish MCI from multi-infarct dementia. A score of ≤ 4 suggests MCI Informed consent capability
- Adequate visual and auditory acuity to allow neuropsychological testing and participation in the ocular blood flow measurements
- A potential participant has to be on stable doses of all medications he/she is taking because of consisting illnesses according to medical for at least 30 days prior inclusion, if considered relevant by the investigator.
Exclusion Criteria for patients:
- 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
Exclusion criteria for healthy volunteers:
- 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
- Best corrected visual acuity < 0.5 Snellen
- Ametropia 6 Dpt
- Pregnancy or planned pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Healthy
Healthy volunteers
|
Other Names:
Other Names:
|
Experimental: Mild cognitive impairment
Patients with mild cognitive impairment
|
Other Names:
Other Names:
|
Experimental: Alzheimer Disease
Patients with Alzheimer Disease
|
Other Names:
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Flicker induced increase in retinal blood flow
Time Frame: 1 day
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 27, 2016
Primary Completion (Anticipated)
September 1, 2023
Study Completion (Anticipated)
September 30, 2023
Study Registration Dates
First Submitted
December 21, 2015
First Submitted That Met QC Criteria
January 21, 2016
First Posted (Estimate)
January 26, 2016
Study Record Updates
Last Update Posted (Actual)
April 7, 2022
Last Update Submitted That Met QC Criteria
April 6, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OPHT-180515
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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