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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07701161

Enrollment

1000

Registered

2026-07-14

Start date

2025-01-13

Completion date

2026-08-01

Last updated

2026-07-14

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

Conditions

Alzheimer s Disease, Biomarkers, MCI Conversion to Dementia, pTau217

Keywords

Alzheimer's disease, Neurogen Biomarking, pTau, MCI, Dementia

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

40 Years to 90 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Contacts

CONTACTAnsam Eghzawi, MD

ansam@neurogenbiomarking.com+18109410076

CONTACTElisabeth Thijssen, PhD

elisabeth@neurogenbiomarking.com+16282788161

PRINCIPAL_INVESTIGATORRany Aburashed

Insight Health Systems

Outcome results