OCT-Angiography and Adaptive Optics in Patients With Memory Impairment (OCTAVO)

Fondation Ophtalmologique Adolphe de Rothschild

Status: Enrolling

Conditions: Parkinsons Disease With Dementia; Alzheimer Disease; Amnesia; Lewy Body Disease

Treatments: Procedure: Blood pressure measurement; Procedure: Ophthalmological exam

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT04389437

AMR_2020_3

Details and patient eligibility

About

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.

Enrollment: 450 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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450 participants in 3 patient groups

NCD patients (case)

Experimental group

Description:

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

Treatment:

Procedure: Ophthalmological exam

Procedure: Blood pressure measurement

Control patients with memory complaint

Other group

Description:

Normal neuropsychological evaluation during assessment

Treatment:

Procedure: Ophthalmological exam

Procedure: Blood pressure measurement

Control patients without memory complaint

Other group

Description:

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

Treatment:

Procedure: Ophthalmological exam

Procedure: Blood pressure measurement