Multimodal Optical-imaging of Retinal manifestations of Alzheimer*s Disease

• Conditions: Alzheimer's Disease; dementia; 10029301

• Registration Number: NL-OMON52275
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 150

Inclusion Criteria

Age >= 50 years
Mini Mental State Exam (MMSE) greater or equal to 17 (patients who are mentally
competent)
Available AD biomarker information

Exclusion Criteria

- Pupil dilation inadequate or contraindicated
- Presence of glaucoma, retinal vasculopathy (diabetic, hypertensive)
- Presence of moderate / late-stage age-related macular degeneration
- Media opacities (cataract) precluding good quality imaging
- Refractive error outside the range -6D to +6D
- Inability to obtain good quality images with the OCT(-A), widefield fundus
photography and metabolic hyperspectral retinal camera
- Ocular conditions including eye infection, eye inflammation, eye surgery
within the
last 28 days or other acute eye conditions.
Presence of other neurodegenerative disease (i.e. other causes of dementia, MS,
Parkinson Disease)

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. Differences between AD patients, patients with SMC and healthy controls for<br /><br>all parameters measured by the different retinal imaging techniques (including<br /><br>OCT, OCT-A, ultra-widefield fundus photography and metabolic hyperspectral<br /><br>retinal camera) at baseline and after two years.<br /><br>2. Comparison of intra-individual differences (change over time) between AD<br /><br>patients, patients with SMC and healthy controls for all parameters measured by<br /><br>the multimodal retinal imaging platform at baseline and after two years.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Correlation of the results of the different retinal imaging techniques with<br /><br>established disease biomarkers (CSF concentration of A&beta;, Tau, and pTau,<br /><br>hippocampal and cortical atrophy on MRI, and neuropsychological findings).<br /><br>2. Correlation of possible new AD biomarkers in tear film (in collaboration<br /><br>with Maastricht University Medical Center, MUMC+), to the different retinal<br /><br>imaging </p><br>