Development of a Home Test for Measuring Blood P-tau217 in Alzheimer's Disease Using the Tasso Lancet Device

NCT07701161 · tracked via the Priya Life Science USA tracker

Sponsor

Neurogen Biomarking LLC

Phase

Observational

Started

2025-01-13

Last updated

2026-07-14

Condition(s) studied

Alzheimer s DiseaseMCI Conversion to DementiapTau217Biomarkers

Study summary

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.

Eligibility

Sex

ALL

Min age

40 Years

Max age

90 Years

Healthy volunteers

Accepted

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

Primary outcome measure(s)

Agreement between p-tau217 concentration in Tasso device capillary blood and venipuncture blood — Baseline
Mean, mean fold-change, and effect size of p-tau217 in Tasso samples between AD and non-AD groups.

Trial sites (5)

Facility	City	Region	Status
Insigth Hospital and Medical Center Chicago	Chicago	Illinois	Recruiting
Insight Hospital and Medical Center Dearborn	Dearborn	Michigan	Active Not Recruiting
Insight Institute of Neurology and Neurosurgery	Flint	Michigan	Active Not Recruiting
Memorial Healthcare Hospital	Owosso	Michigan	Active Not Recruiting
Wake Forest Baptist Medical Center	Winston-Salem	North Carolina	Active Not Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07701161 on ClinicalTrials.gov ↗ ← All trials in the USA