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Recruiting NCT07701161

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

Observational Alzheimer s Disease MCI Conversion to Dementia pTau217 Biomarkers

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Alzheimer s Disease, MCI Conversion to Dementia, pTau217, Biomarkers. Basic parameters: 40 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Primary outcome measures

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

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 5 centers
  • Insigth Hospital and Medical Center Chicago — Chicago
  • Insight Hospital and Medical Center Dearborn — Dearborn
  • Insight Institute of Neurology and Neurosurgery — Flint
  • Memorial Healthcare Hospital — Owosso
  • Wake Forest Baptist Medical Center — Winston-Salem

Identifiers

NCT: NCT07701161 · Neurogen-12951

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗