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NCT05107882 · ClinicalTrials.gov registry record
Optina Diagnostics' Cerebral ß-Amyloid Status (CAS) Test
A clinical trial, sponsored by Optina Diagnostics.
- Completed
- Registry status
- 466
- Enrollment target
NCT05107882: Completed study, sponsored by Optina Diagnostics.
NCT05107882 is a clinical trial that has completed, run by Optina Diagnostics. The registered enrollment target is 466 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05107882 has completed, sponsored by Optina Diagnostics.
- COMPLETED
- Registry status
- 466 participants
- Enrollment target
Study Summary
This observational, cross-sectional study is designed to validate a novel diagnostic test for the detection of phenotypic changes in the retina that correlate with likely PET amyloid status (negative or positive), to aid in the evaluation of adult patients with cognitive impairment who are being evaluated for Alzheimer's disease and other causes of cognitive decline. The CAS test is an adjunct to other diagnostic evaluations, and is indicated for use with the Optina Diagnostics' MHRC (K200254).
Primary Outcome
Presence of absence of beta-amyloid plaques in the retina where the accuracy will be assessed using positive percent agreement (PPA) and negative percent agreement (NPA) with 95% confidence intervals.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 466 participants |
| Start Date | 2022-06-07 |
| Est. Completion | 2024-07-25 |
What the finished NCT05107882 record still lists
NCT05107882 is an observational study that tracks outcomes without assigning an intervention. The registered 466 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT05107882 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05107882 about?
NCT05107882 is a clinical study titled "Optina Diagnostics' Cerebral ß-Amyloid Status (CAS) Test". This observational, cross-sectional study is designed to validate a novel diagnostic test for the detection of phenotypic changes in the retina that correlate with likely PET amyloid status (negative or positive), to aid in the evaluation of adult patients with cognitive impairment who are being eva...
What is the current status of trial NCT05107882?
This trial is currently completed. The enrollment target is 466 participants. The study started on 2022-06-07. Estimated completion is 2024-07-25.
Who is sponsoring clinical trial NCT05107882?
This trial is sponsored by Optina Diagnostics, which has 2 total clinical trials registered on ClinicalTrials.gov.
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