OCT-Angiography and Adaptive Optics in Patients With Memory Impairment (OCTAVO)
Primary Purpose
Amnesia, Alzheimer Disease, Lewy Body Disease
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Ophthalmological exam
Blood pressure measurement
Sponsored by
About this trial
This is an interventional diagnostic trial for Amnesia focused on measuring OCT-A, adaptative optics
Eligibility Criteria
Inclusion Criteria:
- Patient presenting in memory consultation for memory complaint or person accompanying a patient in memory consultation for memory complaint
Exclusion Criteria:
- pregnant or lactating women
- history of known non-degenerative neurological pathology (tumor, stroke territorial, in particular multiple sclerosis)
- history of retinal pathology
- ametropia greater in absolute value than 3 diopters on the sphere, and 1.5 diopters on the cylinder.
- history of taking ethambutol or synthetic antimalarial
- Mini Mental State Score (MMS) and / or Montreal Cognitive Assessment (MoCA) <10 for patients and 26 for accompanying persons
- MRI contraindication (for patients only)
Sites / Locations
- Hôpital Fondation A. de RothschildRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Other
Other
Arm Label
NCD patients (case)
Control patients with memory complaint
Control patients without memory complaint
Arm Description
Patient diagnosed with Alzheimer's disease or parkinsonian dementia / Lewy body dementia or other mild or severe NCD defined by international criteria.
Normal neuropsychological evaluation during assessment
MMS score and / or the Montreal Cognitive Assessment grid (MoCA) ≥26 / 30, No memory complaint
Outcomes
Primary Outcome Measures
Wall to lumen ratio (WLR)
Measured in adaptive optics, compared between patients case with NCD and patient controls without NDC found
Secondary Outcome Measures
Full Information
NCT ID
NCT04389437
First Posted
May 12, 2020
Last Updated
July 28, 2023
Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
1. Study Identification
Unique Protocol Identification Number
NCT04389437
Brief Title
OCT-Angiography and Adaptive Optics in Patients With Memory Impairment
Acronym
OCTAVO
Official Title
OCT-Angiography and Adaptive Optics in Patients With Memory Impairment
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 26, 2020 (Actual)
Primary Completion Date
June 2026 (Anticipated)
Study Completion Date
June 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Studies suggest an association between retinal abnormalities and NCD (Neuro Cognitive Disorders) whether they are linked to proven or prodromal Alzheimer's disease (aMCI : amnestic mild cognitive impairment), or to other neurodegenerative diseases such as frontotemporal dementia or Lewy body diseases.
These retinal anomalies objectified by OCT-A (Optical coherence tomography angiography) and adaptive optics (AO) appear different depending on the pathologies and could therefore serve as markers in vivo of the pathophysiological processes underlying NCD.
No study to date has studied the retina and its vessels in NCD using adaptive optics. In this pilot study, we are proposing a combination of two new ophthalmological imaging techniques (OCT-A and AO), which allow rapid in vivo analysis in a completely non-invasive way of the morphology of small vessels as well as architecture of the retina to better specify the retinal anomalies associated with NCD. We will compare the parameters in OCT-A and AO between patients with NCD and controls without NCD (with memory complaint or without) and will seek to determine if there are different profiles according to the causes of NCD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amnesia, Alzheimer Disease, Lewy Body Disease, Parkinsons Disease With Dementia
Keywords
OCT-A, adaptative optics
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
450 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NCD patients (case)
Arm Type
Experimental
Arm Description
Patient diagnosed with Alzheimer's disease or parkinsonian dementia / Lewy body dementia or other mild or severe NCD defined by international criteria.
Arm Title
Control patients with memory complaint
Arm Type
Other
Arm Description
Normal neuropsychological evaluation during assessment
Arm Title
Control patients without memory complaint
Arm Type
Other
Arm Description
MMS score and / or the Montreal Cognitive Assessment grid (MoCA) ≥26 / 30, No memory complaint
Intervention Type
Procedure
Intervention Name(s)
Ophthalmological exam
Intervention Description
OCT-A and AO
Intervention Type
Procedure
Intervention Name(s)
Blood pressure measurement
Intervention Description
Blood pressure measurement before the ophthalmological exam
Primary Outcome Measure Information:
Title
Wall to lumen ratio (WLR)
Description
Measured in adaptive optics, compared between patients case with NCD and patient controls without NDC found
Time Frame
Baseline (Inclusion)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patient presenting in memory consultation for memory complaint or person accompanying a patient in memory consultation for memory complaint
Exclusion Criteria:
pregnant or lactating women
history of known non-degenerative neurological pathology (tumor, stroke territorial, in particular multiple sclerosis)
history of retinal pathology
ametropia greater in absolute value than 3 diopters on the sphere, or/and 1.5 diopters on the cylinder.
history of taking ethambutol for more than 2 months
history of takingsynthetic antimalarial for more than 2 years
Mini Mental State Score (MMS) and / or Montreal Cognitive Assessment (MoCA) <10 for patients and 26 for accompanying persons
MRI contraindication (for patients only)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amélie YACHITZ, MD
Phone
(0)148036454
Ext
+33
Email
ayavchitz@for.paris
First Name & Middle Initial & Last Name or Official Title & Degree
Antoine MOULIGNIER, MD
Email
amoulignier@for.paris
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antoine MOULIGNIER, MD
Organizational Affiliation
Fondation A. de Rothschild
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Fondation A. de Rothschild
City
Paris
ZIP/Postal Code
75019
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antoine MOULIGNIER, MP
Email
amoulignier@for.paris
First Name & Middle Initial & Last Name & Degree
Martine MAUGET FAYSSE, MD
Phone
(0)148036437
Ext
+33
Email
mmfaysse@for.paris
12. IPD Sharing Statement
Learn more about this trial
OCT-Angiography and Adaptive Optics in Patients With Memory Impairment
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