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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON55124

Enrollment

100

Registered

2020-07-10

Start date

2021-07-08

Completion date

Unknown

Last updated

2024-04-15

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: - 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

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).

Design outcomes

Primary

Measure	Time frame
The diagnostic performance of MHRC by determining the sensitivity and specificity using amyloid status, measured with amyloid PET as reference.	—

Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results