OCT-Angiography and Adaptive Optics in Patients With Memory Impairment

Alzheimer Disease Clinical Trial

— OCTAVO  

Official title:

OCT-Angiography and Adaptive Optics in Patients With Memory Impairment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04389437
• Other study ID #: AMR_2020_3
• Status: Recruiting
• Phase: N/A
• Start date: June 26, 2020
• Est. completion date: June 2026

Study information

• Verified date: July 2023
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: Amélie YACHITZ, MD
• Phone: (0)148036454
• Email: ayavchitz[@]for.paris
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: June 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Fondation A. de Rothschild	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wall to lumen ratio (WLR)	Measured in adaptive optics, compared between patients case with NCD and patient controls without NDC found	Baseline (Inclusion)