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

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.

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Key information

Conditions

Alzheimer s Disease Alzheimer Disease Biomarkers Brain Diseases Central Nervous System Diseases Dementia MCI Conversion to Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies pTau217

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Insigth Hospital and Medical Center Chicago, Chicago, Illinois, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Agreement between p-tau217 concentration in Tasso device capillary blood and venipuncture blood

Time frame: Baseline

Mean, mean fold-change, and effect size of p-tau217 in Tasso samples between AD and non-AD groups.

Study contacts

Contact information is provided by the study sponsor or research team.

Ansam Eghzawi, MD

CONTACT

[email protected]

+18109410076

Elisabeth Thijssen, PhD

CONTACT

[email protected]

+16282788161

Sponsors and collaborators

Lead sponsor

Neurogen Biomarking LLC

Industry

Registry information

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Jul 14, 2026
Registry last updated: Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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