ClinicalTrials.gg
RecruitingNCT04389437OCTAVOUpdated Oct 30, 2026

OCT-Angiography and Adaptive Optics in Patients With Memory Impairment

An interventional study of Ophthalmological exam and Blood pressure measurement in Amnesia, Alzheimer Disease and Lewy Body Disease, sponsored by Fondation Ophtalmologique Adolphe de Rothschild. Recruiting at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-30.

Sponsored by Fondation Ophtalmologique Adolphe de Rothschild · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Started Jun 2020; still recruiting 6 years 4 months later.
Updated Oct 30, 2026Primary completion movedStudy completion movedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
450
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

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

Keywords

  • OCT-A
  • adaptative optics
03

In context

Amnesia

22 studies on the registry are indexed under Amnesia; 2 are open to participants now.

This study's planned enrollment of 450 is above the median of 62 across 19 interventional studies indexed under Amnesia.

Browse Amnesia studies →

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild is the lead sponsor of 316 studies on the registry; 78 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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 (MoCA) \<10 for patients and 26 for accompanying persons
  • MRI (for patients only)
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
450 participants (estimated)

Study arms

  • 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 · Procedure: Blood pressure measurement

  • Other
    Control patients with memory complaint

    Normal neuropsychological evaluation during assessment

    Procedure: Ophthalmological exam · Procedure: Blood pressure measurement

  • Other
    Control patients without memory complaint

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

    Procedure: Ophthalmological exam · Procedure: Blood pressure measurement

Interventions

  • ProcedureOphthalmological exam

    OCT-A and AO

  • ProcedureBlood pressure measurement

    Blood pressure measurement before the ophthalmological exam

06

What researchers measure

Primary outcomes

  1. Wall to lumen ratio (WLR)

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

    Time frame: Baseline (Inclusion)

07

Study locations

1 of 1 sites recruiting
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Started Jun 2020 (actual). Primary completion is estimated for Jun 2027, 84 months after the start.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 30, 2026: primary completion Jun 2026 → Jun 2027 and completion Jun 2026 → Jun 2027.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
May 12, 2020
First posted
May 15, 2020
StartActual
Jun 26, 2020
Primary completionEst.
Jun 2027was Jun 2026
CompletionEst.
Jun 2027was Jun 2026
Last update
Oct 30, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Primary completion
Jun 2026→Jun 2027
Oct 30, 2026
Study completion
Jun 2026→Jun 2027
Oct 30, 2026
Show all 1 update
  1. Oct 30, 2026
    Primary completion Jun 2026→Jun 2027
    Study completion Jun 2026→Jun 2027
    + 2 other changes: verification date and oversight details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT04389437
Responsible party
Sponsor
First posted
May 15, 2020
Start date
Jun 26, 2020
Primary completion
Jun 2027 (estimated)
Completion
Jun 2027 (estimated)
Last update
Oct 30, 2026

Study contacts

Amélie YACHITZ, MD
Contact
ayavchitz@for.paris
(0)148036454 ext. +33
Antoine MOULIGNIER, MD
Contact
amoulignier@for.paris
Antoine MOULIGNIER, MD
principal investigator · Fondation A. de Rothschild

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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