Recruiting

p-tau217 vs. Venipuncture

Sponsor:

Neurogen Biomarking LLC

Code:

NCT07701161

Conditions

Alzheimer s Disease

MCI Conversion to Dementia

pTau217

Biomarkers

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Accepted

Study Details

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.

Conditions

Alzheimer s Disease

MCI Conversion to Dementia

pTau217

Biomarkers

Study ID

NCT07701161

Start date

Jan 13, 2025

Status verified date

Jul, 2026

Completion date

Aug 1, 2026

Anticipated

Primary completion date

Mar 20, 2026

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

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

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

AD subjects

Amyloid PET/CSF confirmed and clinically diagnosed

Healthy Controls

No history of cognitive impairment

Non-AD cognitively impaired (amyloid-negative)

Cognitive impairment not due to AD, confirmed amyloid-negative via PET/CSF

Primary outcome measure

  • Agreement between p-tau217 concentration in Tasso device capillary blood and venipuncture blood [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Ansam Eghzawi, MD

+18109410076ansam@neurogenbiomarking.com

Elisabeth Thijssen, PhD

+16282788161elisabeth@neurogenbiomarking.com

Locations

Insigth Hospital and Medical Center Chicago

Recruiting

Chicago, Illinois, United States, 60616

Contacts

Ansam Eghzawi, MD

+18109410076ansam@neurogenbiomarking.com

Elisabeth Thijssen, PhD

+16282788161elisabeth@neurogenbiomarking.com

More Information

Sponsor

Neurogen Biomarking LLC

Last update posted

Jul 14, 2026

Last verified

Jul, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Neurogen Biomarking LLC on 2026-07-14.