NCT04389437 OCT-Angiography and Adaptive Optics in Patients With Memory Impairment
| NCT ID | NCT04389437 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondation Ophtalmologique Adolphe de Rothschild |
| Condition | Amnesia |
| Study Type | INTERVENTIONAL |
| Enrollment | 450 participants |
| Start Date | 2020-06-26 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 450 participants in total. It began in 2020-06-26 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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)
Contact & Investigator
Antoine MOULIGNIER, MD
PRINCIPAL INVESTIGATOR
Fondation A. de Rothschild
Frequently Asked Questions
Who can join the NCT04389437 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Amnesia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04389437 currently recruiting?
Yes, NCT04389437 is actively recruiting participants. Contact the research team at ayavchitz@for.paris for enrollment information.
Where is the NCT04389437 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT04389437 clinical trial?
NCT04389437 is sponsored by Fondation Ophtalmologique Adolphe de Rothschild. The principal investigator is Antoine MOULIGNIER, MD at Fondation A. de Rothschild. The trial plans to enroll 450 participants.