Home Test for Measuring Plasma P-tau217 in Alzheimer's Disease

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

The goal of this is to develop an easy at home test that can be used to assist in diagnosing Alzheimer's disease (AD). The test will use an FDA approved device for at home blood sample collection. The blood samples will be evaluated to determine if the concentration of p-tau217, a biomarker that is elevated in AD patients, measured from blood samples collected using the at home device is comparable to the results obtained from blood samples collected by venipuncture.

Study Overview

• Status: Terminated
• Conditions: Alzheimer Disease; Healthy Subjects
• Intervention / Treatment: Device: Tasso Lancet Device

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60616
      • Insight Research Institute/Insight Hospital and Medical Center Chicago
  • Michigan
    • Flint, Michigan, United States, 48507
      • Insight Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Subject with Alzheimer's Disease Only: diagnosed according the NIA-AA diagnostic AD criteria
• Healthy Control Only: Subject does not have history of cognitive impairment
• 55 - 90 years old
• Subject able to comply with study procedures
• Subjects must be able to use the Tasso device for blood sample collection as per the provided instructions (can be performed with the assistance of a caregiver)
• Subjects must be able to undergo IV sampling
• Have a study partner who will provide written informed consent to participate, and assist with blood collection when applicable

Exclusion Criteria:

• Subjects with systemic conditions which were not adequately controlled through a stable medication regimen
• Subjects with any known significant bleeding disorders or conditions that contraindicate blood sample collection (e.g., hemophilia, severe thrombocytopenia)
• Subjects with a known history of severe skin allergies or reactions to adhesives (since the Tasso device involves adhesive application to the skin)
• Subjects currently taking anticoagulant or antiplatelet medications that could interfere with blood collection or increase the risk of complications
• Subjects who have undergone major surgery or have been hospitalized for any reason in the last 3 months prior to study enrollment
• Participation in a clinical study within the 2 month

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Blood draw using IV and at home device	Device: Tasso Lancet Device; blood samples will be obtained from all participants using Tasso device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Agreement between measurements of P-tau217 concentration in blood samples from Tasso device and venipuncture	Day 1

Secondary Outcome Measures

Outcome Measure	Time Frame
Means of p-tau217 concentration in subjects with and without AD	Day 1
Agreement between measurements of P-tau217 concentration by the ALZpath P-tau217 and Janssen P-tau217+ assays	Day 1
Percentage of Tasso devices which are loss, damaged, or with inadequate blood volume for analysis	Day 1
Mean fold-change of p-tau217 concentration in subjects with and without AD	Day 1
Effect size of p-tau217 concentration in subjects with and without AD	Day 1

Collaborators and Investigators

• Sponsor: Insight Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2024
• Primary Completion (Actual): December 7, 2024
• Study Completion (Actual): December 7, 2024

Study Registration Dates

• First Submitted: September 19, 2024
• First Submitted That Met QC Criteria: September 30, 2024
• First Posted (Actual): October 1, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 9, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Alzheimer Disease
• Other Study ID Numbers: STU24080011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified Data will be shared
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes