Medical device approval of oligomerized amyloid-ß measurement technology

Single-arm, open, multi-center, retrospective, pivotal clinical trial to evaluate the Clinical sensitivity and specificity for assistant of Alzheimer’s disease diagnosis of inBloodTM OAß test

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0002581

Enrollment

104

Registered

2017-12-06

Start date

2017-06-30

Completion date

Unknown

Last updated

2019-03-11

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

Conditions

None listed

Interventions

Medical Device : This study is aimed at diagnosing Alzheimer&#39

s disease rather than treating it. The selection criteria and exclusion criteria were simplified and divided into those who were diagnosed with Alzheimer&#39

s disease and those who were not. plasma samples from Alzheimer&#39

s disease patients and normal controls who were clinically diagnosed according to the selection and exclusion criteria were applied to the inBloodTM OAß test. Plasma oligomerized beta-amyloid levels a

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The subject groups are selected as follows. Alzheimer’s disease patient group must be age of 50~90 male/female diagnosed probable Alzheimer’s disease or definite Alzheimer’s disease according to the NINCDS-ADRDA Alzheimer's Criteria and normal group must be age of 50~90 male/female without diagnosis of dementia.

Exclusion criteria

Exclusion criteria: Judged not to be qualified by the investigator with clinical diagnosis of dementia, encephalopathy, and delirium will be excluded from participation in this trial.

Design outcomes

Primary

Measure	Time frame
Clinical sensitivity and specificity of measured concentration of oligomerized Aß	—

Secondary

Measure	Time frame
Clinical positive and negative predictive value of measured concentration of oligomerized Aß	—

Countries

Korea, Republic of

Contacts

Public ContactYoung Suk An

Seoul National University Bundang Hospital

hyun717@nate.com+82-31-787-8452

Outcome results