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Recruiting NCT04389437

OCT-Angiography and Adaptive Optics in Patients With Memory Impairment

No phase Interventional Amnesia Alzheimer Disease Lewy Body Disease Parkinsons Disease With Dementia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ophthalmological exam, Blood pressure measurement.
Who it may be relevant to
Registry conditions: Amnesia, Alzheimer Disease, Lewy Body Disease, Parkinsons Disease With Dementia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Procedure Ophthalmological exam
    OCT-A and AO
  • Procedure Blood pressure measurement
    Blood pressure measurement before the ophthalmological exam

Primary outcome measures

  • Wall to lumen ratio (WLR) [Time frame: Baseline (Inclusion)]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

France · 1 center
  • Hôpital Fondation A. de Rothschild — Paris

Identifiers

NCT: NCT04389437 · AMR_2020_3

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗