Medical device approval of oligomerized amyloid-ß measurement technology
Not Applicable
Recruiting
- Conditions
- Diseases of the nervous system
- Registration Number
- KCT0002581
- Lead Sponsor
- PeopleBio
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 104
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
Judged not to be qualified by the investigator with clinical diagnosis of dementia, encephalopathy, and delirium will be excluded from participation in this trial.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical sensitivity and specificity of measured concentration of oligomerized Aß
- Secondary Outcome Measures
Name Time Method Clinical positive and negative predictive value of measured concentration of oligomerized Aß