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Recruiting Observational

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)

FacilityCityRegionStatus
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