Development of a Home Test for Measuring Blood P-tau217 in Alzheimer's Disease Using the Tasso Lancet Device
Purpose
This study compares p-tau217 concentrations in blood collected via the Tasso device versus standard venipuncture in subjects with and without Alzheimer's disease, including a subset with confirmed amyloid pathology.
Conditions
- Alzheimer s Disease
- MCI Conversion to Dementia
- pTau217
- Biomarkers
Eligibility
- Eligible Ages
- Between 40 Years and 90 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- AD Amyloid PET/CSF confirmed, healthy control, or amyloid-negative non-AD cognitive impairment Age 40-90 Able to complete Tasso and venipuncture collection Caregiver consent/assistance available if needed
Exclusion Criteria
- Uncontrolled systemic conditions Recent surgery/hospitalization (3 months) Other dementia drug trial (2 months) Pregnancy Prior Donanemab or Lecanemab use
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| AD subjects | Amyloid PET/CSF confirmed and clinically diagnosed | |
| Healthy Controls | No history of cognitive impairment | |
| Non-AD cognitively impaired (amyloid-negative) | Cognitive impairment not due to AD, confirmed amyloid-negative via PET/CSF |
Recruiting Locations
Insigth Hospital and Medical Center Chicago
Chicago, Illinois 60616
Chicago, Illinois 60616
More Details
- Status
- Recruiting
- Sponsor
- Neurogen Biomarking LLC