OCT-Angiography and Adaptive Optics in Patients With Memory Impairment (OCTAVO)

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.

Study Overview

• Status: Recruiting
• Conditions: Alzheimer Disease; Lewy Body Disease; Amnesia; Parkinsons Disease With Dementia
• Intervention / Treatment: Procedure: Ophthalmological exam; Procedure: Blood pressure measurement

• Study Type: Interventional
• Enrollment (Estimated): 450
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Antoine MOULIGNIER, MD; Email: amoulignier@for.paris
• Study Contact Backup: Name: Amélie YACHITZ, MD; Phone Number: +33 (0)148036454; Email: ayavchitz@for.paris

Study Locations

• France
  • Paris, France, 75019
    • Recruiting
    • Hôpital Fondation A. de Rothschild
    • Contact: Antoine MOULIGNIER, MP; Email: amoulignier@for.paris
    • Contact: Martine MAUGET FAYSSE, MD; Phone Number: +33 (0)148036437; Email: mmfaysse@for.paris

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NCD patients (case); Patient diagnosed with Alzheimer's disease or parkinsonian dementia / Lewy body dementia or other mild or severe NCD defined by international criteria.	Procedure: Ophthalmological exam; OCT-A and AO; Procedure: Blood pressure measurement; Blood pressure measurement before the ophthalmological exam
Other: Control patients with memory complaint; Normal neuropsychological evaluation during assessment	Procedure: Ophthalmological exam; OCT-A and AO; Procedure: Blood pressure measurement; Blood pressure measurement before the ophthalmological exam
Other: Control patients without memory complaint; MMS score and / or the Montreal Cognitive Assessment grid (MoCA) ≥26 / 30, No memory complaint	Procedure: Ophthalmological exam; OCT-A and AO; Procedure: Blood pressure measurement; Blood pressure measurement before the ophthalmological exam

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wall to lumen ratio (WLR)	Measured in adaptive optics, compared between patients case with NCD and patient controls without NDC found	Baseline (Inclusion)

Collaborators and Investigators

• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild
• Investigators: Principal Investigator: Antoine MOULIGNIER, MD, Fondation A. de Rothschild

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2020
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: May 12, 2020
• First Submitted That Met QC Criteria: May 14, 2020
• First Posted (Actual): May 15, 2020

Study Record Updates

• Last Update Posted (Estimated): September 29, 2025
• Last Update Submitted That Met QC Criteria: September 26, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: OCT-A; adaptative optics
• Additional Relevant MeSH Terms: Synucleinopathies; Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurobehavioral Manifestations; Neurocognitive Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Memory Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Alzheimer Disease; Lewy Body Disease; Amnesia
• Other Study ID Numbers: AMR_2020_3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No