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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON52275

Enrollment

150

Registered

2021-09-16

Start date

2021-08-01

Completion date

Unknown

Last updated

2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease dementia

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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)

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

Measure	Time frame
1. Correlation of the results of the different retinal imaging techniques with established disease biomarkers (CSF concentration of Aβ, Tau, and pTau, hippocampal and cortical atrophy on MRI, and neuropsychological findings). 2. Correlation of possible new AD biomarkers in tear film (in collaboration with Maastricht University Medical Center, MUMC+), to the different retinal imaging	—

Countries

Netherlands

Outcome results