CClinicalTrials.gg
RecruitingNCT07701161Updated Jul 14, 2026

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

An observational study in Alzheimer s Disease, MCI Conversion to Dementia and pTau217, sponsored by Neurogen Biomarking LLC. Recruiting at 5 sites in United States. Open to participants aged 40 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-14.

Sponsored by Neurogen Biomarking LLC · Observational

From the registry’s dates

  • Started Jan 2025; still recruiting 1 year 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
40 Years to 90 Years
Sex
All
01

Study 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.

02

Conditions studied

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

Keywords

  • Alzheimer's disease
  • Neurogen Biomarking
  • pTau
  • MCI
  • Dementia
03

In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 200 across 751 observational studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

This is the only study on the registry with Neurogen Biomarking LLC as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Adults aged 40-90 recruited through clinical records review, advertising, and community outreach, including AD patients, cognitively healthy controls, and non-AD cognitively impaired individuals with confirmed amyloid-negative status. A subset has amyloid pathology confirmed via PET or CSF.

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

Exclusion Criteria:

  • Uncontrolled systemic conditions Recent surgery/hospitalization (3 months) Other dementia drug trial (2 months) Pregnancy Prior Donanemab or Lecanemab use
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

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

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

    Time frame: Baseline

07

Study locations

1 of 5 sites recruiting
  • Insigth Hospital and Medical Center Chicago
    Chicago, Illinois 60616, United States
    Recruiting
  • Insight Hospital and Medical Center Dearborn
    Dearborn, Michigan 48126, United States
    Active, not recruiting
  • Insight Institute of Neurology and Neurosurgery
    Flint, Michigan 48507, United States
    Active, not recruiting
  • Memorial Healthcare Hospital
    Owosso, Michigan 48867, United States
    Active, not recruiting
  • Wake Forest Baptist Medical Center
    Winston-Salem, North Carolina 27157, United States
    Active, not recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07701161
Lead sponsor
Neurogen Biomarking LLC
Responsible party
Sponsor
First posted
Jul 14, 2026
Start date
Jan 13, 2025
Primary completion
Mar 20, 2026
Completion
Aug 1, 2026 (estimated)
Last update
Jul 14, 2026

Study contacts

Ansam Eghzawi, MD
Contact
ansam@neurogenbiomarking.com
+18109410076
Elisabeth Thijssen, PhD
Contact
elisabeth@neurogenbiomarking.com
+16282788161
Rany Aburashed
principal investigator · Insight Health Systems

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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