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

NCT07701161 | Recruiting

• 1 other identifier: Neurogen-12951
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 5

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

Keywords

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

Outcome Measures

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.

  Baseline

Study Arms (3)

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

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Neurogen Biomarking LLC: lead

Study Sites (5)

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

Biospecimen

Retention: SAMPLES WITH DNA

Plasma and serum from venipuncture and Tasso device capillary blood samples; dried blood spot (DBS) cards from a subset of participants. Samples are stored at -80°C (plasma/serum) or room temperature in desiccant-containing pouches (DBS), and may be used for future p-tau217 assay development and validation activities.

MeSH Terms

Conditions

Alzheimer Disease; Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Rany Aburashed

  Insight Health Systems

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ansam Eghzawi, MD

CONTACT

+18109410076; ansam@neurogenbiomarking.com

Elisabeth Thijssen, PhD

CONTACT

+16282788161; elisabeth@neurogenbiomarking.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 14, 2026
• Study Start: January 13, 2025
• Primary Completion: March 20, 2026
• Study Completion: August 1, 2026
• Last Updated: July 14, 2026

Record last verified: 2026-07

Locations

US (5)