NCT07701161RecruitingAccepts Healthy Volunteers

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

Neurogen Biomarking LLC

Start Date

1/13/2025

Completion Date

8/1/2026

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 Criteria

Age Range: 40 years to 90 years

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

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Conditions

Alzheimer s DiseaseMCI Conversion to DementiapTau217Biomarkers

Locations

Insigth Hospital and Medical Center Chicago

Chicago, Illinois 60616

United States

Insight Hospital and Medical Center Dearborn

Dearborn, Michigan 48126

United States

Insight Institute of Neurology and Neurosurgery

Flint, Michigan 48507

United States

Memorial Healthcare Hospital

Owosso, Michigan 48867

United States

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina 27157

United States