Mild Cognitive ImpairmentNCT02663531
Retinal Neuro-vascular Coupling in Patients With Neurodegenerative Disease
A study testing DVA, FDOCT and Pattern ERG in people with Mild Cognitive Impairment and Alzheimer Disease, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment, Alzheimer Disease, Healthy
- What is being tested?
- DVA, FDOCT and Pattern ERG
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteAustria
- Study dates
- 27 Sep 2016to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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
- Best corrected visual acuity < 0.5 Snellen
- Ametropia 6 Dpt
- Pregnancy or planned pregnancy
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, 1090
Gerhard Garhöfer, MD, +43 (1) 40400 ext. 29810, gerhard.garhoefer@meduniwien.ac.at
Gerhard Garhöfer, MD
About this study
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.
- Conditions
- Mild Cognitive Impairment, Alzheimer Disease, Healthy
- Being tested
- DVA, FDOCT, Pattern ERG, Optical Coherence Tomography
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DVADevice
Also called Dynamic Vessel Analyzer
FDOCTDevice
Also called Fourier Domain Color Doppler Optical Coherence Tomography
Pattern ERGDevice
Optical Coherence TomographyDevice
| Study group | Role | What they receive |
|---|---|---|
| Mild cognitive impairment | Experimental | Patients with mild cognitive impairment Receives: Device: DVA; Device: FDOCT; Device: Pattern ERG; Device: Optical Coherence Tomography |
| Alzheimer Disease | Experimental | Patients with Alzheimer Disease Receives: Device: DVA; Device: FDOCT; Device: Pattern ERG; Device: Optical Coherence Tomography |
| Healthy | Experimental | Healthy volunteers Receives: Device: DVA; Device: FDOCT; Device: Pattern ERG; Device: Optical Coherence Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flicker induced increase in retinal blood flow
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2016 (estimated)
- Study start27 Sep 2016
- Primary completionSep 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gerhard Garhofer, Medical University of Vienna
- Investigators
- Gerhard Garhöfer, MD, Principal investigator, Department of Clinical Pharmacology, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02663531
- Sponsor's protocol ID
- OPHT-180515
- Status last verified
- Apr 2022
- First submitted
- 21 Dec 2015
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retinal Neuro-vascular Coupling in Patients With Neurodegenerative Disease
- ClinicalTrials.gov ID
- NCT02663531
- Acronym / sponsor ID
- OPHT-180515
- Conditions
- Mild Cognitive Impairment, Alzheimer Disease, Healthy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 27 Sep 2016 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 26 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mild cognitive impairment | Experimental | Device: DVA, Device: FDOCT, Device: Pattern ERG, Device: Optical Coherence TomographyPatients with mild cognitive impairment |
| Alzheimer Disease | Experimental | Device: DVA, Device: FDOCT, Device: Pattern ERG, Device: Optical Coherence TomographyPatients with Alzheimer Disease |
| Healthy | Experimental | Device: DVA, Device: FDOCT, Device: Pattern ERG, Device: Optical Coherence TomographyHealthy volunteers |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DVAAlso: Dynamic Vessel Analyzer | Device | Alzheimer Disease, Healthy, Mild cognitive impairment |
| FDOCTAlso: Fourier Domain Color Doppler Optical Coherence Tomography | Device | Alzheimer Disease, Healthy, Mild cognitive impairment |
| Pattern ERG | Device | Alzheimer Disease, Healthy, Mild cognitive impairment |
| Optical Coherence Tomography | Device | Alzheimer Disease, Healthy, Mild cognitive impairment |
Primary outcome
Flicker induced increase in retinal blood flow
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerhard Garhöfer, MD principal investigator
Department of Clinical Pharmacology, Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DVA, FDOCT and Pattern ERG in people with Mild Cognitive Impairment and Alzheimer Disease, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gerhard Garhöfer, MD (0043140400 ext. 29810, gerhard.garhoefer@medunwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flicker induced increase in retinal blood flow (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2022.