Last reviewed · How we verify
NCT05107882: REPHRASE
Optina Diagnostics' Cerebral ß-Amyloid Status (CAS) Test
trial in Alzheimer Disease in 466 participants. Completed in 25 July 2024.
25 July 2024
Quick facts
| Lead sponsor | Optina Diagnostics Inc. |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 466 |
| Start date | 7 June 2022 |
| Primary completion | 25 July 2024 |
| Estimated completion | 25 July 2024 |
| Sites | 7 locations across Canada, United States |
Conditions studied
- Alzheimer Disease — all drugs for Alzheimer Disease →
- Mild Cognitive Impairment — all drugs for Mild Cognitive Impairment →
- Mild Dementia — all drugs for Mild Dementia →
Sponsor
Optina Diagnostics Inc.
Who can join
Adults 50 to 90, any sex, with Alzheimer Disease or Mild Cognitive Impairment. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05107882
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Optina Diagnostics Inc. trials
Trials by the same sponsor.
- NCT06860568 — The GA in HSI Study · completed
- NCT05903664 — Retinal Deep Phenotyping.TM · withdrawn
- NCT06057493 — RDP Reliability Study · completed
- NCT05903651 — Retinal Deep PhenotypingTM · completed
- NCT06860555 — Hyperspectral Drusen Classification · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05107882 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Optina Diagnostics Inc.
- Last refreshed: 7 August 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05107882.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing