AmnesiaOCTAVONCT04389437
OCT-Angiography and Adaptive Optics in Patients With Memory Impairment
A study testing Ophthalmological exam and Blood pressure measurement in people with Amnesia and Alzheimer Disease, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Amnesia, Alzheimer Disease, Lewy Body Disease
- What is being tested?
- Ophthalmological exam and Blood pressure measurement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteFrance
- Study dates
- 26 Jun 2020to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient presenting in memory consultation for memory complaint or person accompanying a patient in memory consultation for memory complaint
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Antoine MOULIGNIER, MD contact
France1 site, 1 recruiting
- Recruiting
Hôpital Fondation A. de Rothschild
Paris, 75019
Antoine MOULIGNIER, MP, amoulignier@for.paris
Martine MAUGET FAYSSE, MD, (0)148036437 ext. +33, mmfaysse@for.paris
About this study
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.
- Being tested
- Ophthalmological exam, Blood pressure measurement
- Keywords
- OCT-A, adaptative optics
- Medical subject headings
- Amnesia, Alzheimer Disease, Lewy Body Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ophthalmological examProcedure or surgery
OCT-A and AO
Blood pressure measurementProcedure or surgery
Blood pressure measurement before the ophthalmological exam
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Ophthalmological exam; Procedure: Blood pressure measurement |
| Control patients with memory complaint | Other | Normal neuropsychological evaluation during assessment Receives: Procedure: Ophthalmological exam; Procedure: Blood pressure measurement |
| Control patients without memory complaint | Other | MMS score and / or the Montreal Cognitive Assessment grid (MoCA) ≥26 / 30, No memory complaint Receives: Procedure: Ophthalmological exam; Procedure: Blood pressure measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wall to lumen ratio (WLR)
Measured in adaptive optics, compared between patients case with NCD and patient controls without NDC found
Measured: Baseline (Inclusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2020
- Study start26 Jun 2020
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmnesiaStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Antoine MOULIGNIER, MD, Principal investigator, Fondation A. de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04389437
- Sponsor's protocol ID
- AMR_2020_3
- Acronym
- OCTAVO
- Status last verified
- Oct 2026
- First submitted
- 12 May 2020
- Last updated
- 30 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OCT-Angiography and Adaptive Optics in Patients With Memory Impairment
- ClinicalTrials.gov ID
- NCT04389437
- Acronym / sponsor ID
- OCTAVO / AMR_2020_3
- Keywords
- OCT-A, adaptative optics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 26 Jun 2020 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 15 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NCD patients (case) | Experimental | Procedure: Ophthalmological exam, Procedure: Blood pressure measurementPatient diagnosed with Alzheimer's disease or parkinsonian dementia / Lewy body dementia or other mild or severe NCD defined by international criteria. |
| Control patients with memory complaint | Other | Procedure: Ophthalmological exam, Procedure: Blood pressure measurementNormal neuropsychological evaluation during assessment |
| Control patients without memory complaint | Other | Procedure: Ophthalmological exam, Procedure: Blood pressure measurementMMS score and / or the Montreal Cognitive Assessment grid (MoCA) ≥26 / 30, No memory complaint |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient presenting in memory consultation for memory complaint or person accompanying a patient in memory consultation for memory complaint
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ophthalmological examOCT-A and AO | Procedure or surgery | Control patients with memory complaint, Control patients without memory complaint, NCD patients (case) |
| Blood pressure measurementBlood pressure measurement before the ophthalmological exam | Procedure or surgery | Control patients with memory complaint, Control patients without memory complaint, NCD patients (case) |
Primary outcome
Wall to lumen ratio (WLR)
Time frame: Baseline (Inclusion)
Measured in adaptive optics, compared between patients case with NCD and patient controls without NDC found
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Antoine MOULIGNIER, MD contact
Antoine MOULIGNIER, MD principal investigator
Fondation A. de Rothschild
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ophthalmological exam and Blood pressure measurement in people with Amnesia and Alzheimer Disease, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amélie YACHITZ, MD ((0)148036454 ext. +33, ayavchitz@for.paris), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wall to lumen ratio (WLR) (time frame: Baseline (Inclusion)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.