NCT04389437

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for not_applicable

Timeline
1mo left

Started Jun 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Jun 2020Jun 2026

First Submitted

Initial submission to the registry

May 12, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 15, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

June 26, 2020

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

September 29, 2025

Status Verified

September 1, 2025

Enrollment Period

5.9 years

First QC Date

May 12, 2020

Last Update Submit

September 26, 2025

Conditions

AmnesiaAlzheimer DiseaseLewy Body DiseaseParkinsons Disease With Dementia

Keywords

OCT-Aadaptative optics

Outcome Measures

Primary Outcomes (1)

  • Wall to lumen ratio (WLR)

    Measured in adaptive optics, compared between patients case with NCD and patient controls without NDC found

    Baseline (Inclusion)

Study Arms (3)

NCD patients (case)

EXPERIMENTAL

Patient diagnosed with Alzheimer's disease or parkinsonian dementia / Lewy body dementia or other mild or severe NCD defined by international criteria.

Procedure: Ophthalmological examProcedure: Blood pressure measurement

Control patients with memory complaint

OTHER

Normal neuropsychological evaluation during assessment

Procedure: Ophthalmological examProcedure: Blood pressure measurement

Control patients without memory complaint

OTHER

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

Procedure: Ophthalmological examProcedure: Blood pressure measurement

Interventions

Ophthalmological examPROCEDURE

OCT-A and AO

Control patients with memory complaintControl patients without memory complaintNCD patients (case)
Blood pressure measurementPROCEDURE

Blood pressure measurement before the ophthalmological exam

Control patients with memory complaintControl patients without memory complaintNCD patients (case)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient presenting in memory consultation for memory complaint or person accompanying a patient in memory consultation for memory complaint

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Fondation A. de Rothschild

Paris, 75019, France

RECRUITING

MeSH Terms

Conditions

AmnesiaAlzheimer DiseaseLewy Body Disease

Condition Hierarchy (Ancestors)

Memory DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental DisordersDementiaBrain DiseasesCentral Nervous System DiseasesTauopathiesNeurodegenerative DiseasesParkinsonian DisordersBasal Ganglia DiseasesMovement DisordersSynucleinopathies

Study Officials

  • Antoine MOULIGNIER, MD

    Fondation A. de Rothschild

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amélie YACHITZ, MD

CONTACT

(0)148036454ayavchitz@for.paris

Antoine MOULIGNIER, MD

CONTACT

amoulignier@for.paris

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2020

First Posted

May 15, 2020

Study Start

June 26, 2020

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

September 29, 2025

Record last verified: 2025-09

Locations

FR(1)