OCT-Angiography and Adaptive Optics in Patients With Memory Impairment

NCT ID: NCT04389437

Last Updated: 2025-09-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 450 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-26
• Study Completion Date: 2026-06-30

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.

Conditions

Amnesia; Alzheimer Disease; Lewy Body Disease; Parkinsons Disease With Dementia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Ophthalmological exam

Intervention Type: PROCEDURE

OCT-A and AO

Blood pressure measurement

Intervention Type: PROCEDURE

Blood pressure measurement before the ophthalmological exam

Control patients with memory complaint

Normal neuropsychological evaluation during assessment

Group Type: OTHER

Ophthalmological exam

Intervention Type: PROCEDURE

OCT-A and AO

Blood pressure measurement

Intervention Type: PROCEDURE

Blood pressure measurement before the ophthalmological exam

Control patients without memory complaint

MMS score and / or the Montreal Cognitive Assessment grid (MoCA) ≥26 / 30, No memory complaint

Group Type: OTHER

Ophthalmological exam

Intervention Type: PROCEDURE

OCT-A and AO

Blood pressure measurement

Intervention Type: PROCEDURE

Blood pressure measurement before the ophthalmological exam

Interventions

Ophthalmological exam

OCT-A and AO

Intervention Type: PROCEDURE

Blood pressure measurement

Blood pressure measurement before the ophthalmological exam

Intervention Type: PROCEDURE

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Antoine MOULIGNIER, MD

Role: PRINCIPAL_INVESTIGATOR

Fondation A. de Rothschild

Locations

Hôpital Fondation A. de Rothschild

Paris, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Amélie YACHITZ, MD

Role: CONTACT

ayavchitz@for.paris

(0)148036454 ext. +33

Antoine MOULIGNIER, MD

Role: CONTACT

amoulignier@for.paris

Facility Contacts

Antoine MOULIGNIER, MP

Role: primary

amoulignier@for.paris

Martine MAUGET FAYSSE, MD

Role: backup

mmfaysse@for.paris

(0)148036437 ext. +33

Other Identifiers

AMR_2020_3

Identifier Type: -

Identifier Source: org_study_id