The diagnostic value of Metabolic Hyperspectral Imaging of the Retina in Alzheimer's disease (MHIRA).

Recruiting

Conditions: Alzheimer's Disease
dementia
10029301

Registration Number: NL-OMON55124

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 100

Inclusion Criteria

- Aged 50-90 years
- Participant had amyloid PET scan preferably within 1 year of inclusion in
this study
- Mini mental state exam >17 (i.e. patients are mentally competent)

Exclusion Criteria

* Pupil dilation inadequate or contraindicated.
* Presence of glaucoma, retinal vascular occlusion or retinopathy (diabetic,
hypertensive).
* Presence of moderate / late stage age-related macular degeneration.
* Media opacities (cataract) precluding a good quality imaging
* Refractive error outside the range -6 D to +6 D.
* Inability to obtain good quality images with the MHRC.
* Ocular conditions that could influence tear biochemical parameters (including
eye infection, eye inflammation, eye surgery within the last 28 days or other
acute eye conditions).

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The diagnostic performance of MHRC by determining the sensitivity and<br /><br>specificity using amyloid status, measured with amyloid PET as reference. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Correlation of MHRC results to syndrome diagnosis (subjective cognitive<br /><br>complaints, mild cognitive impairment (MCI) or dementia) and established AD<br /><br>biomarkers in CSF on brain MRI as well as cognitive performance in predicting<br /><br>the amyloid status, measured with amyloid PET as reference.<br /><br>2. Correlation of MHRC results to multimodal imaging of the retina, i.e.<br /><br>OCT(-A) and widefield fundus photography in predicting the amyloid status,<br /><br>measured with amyloid PET as reference.<br /><br>3. Correlation of MHRC results to possible AD biomarkers as measured in tears<br /><br>in predicting the amyloid status, measured with amyloid PET as reference. </p><br>