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

NCT06622135 | Terminated FDA Device

• 1 other identifier: STU24080011
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Alzheimer Disease; Healthy Subjects

Outcome Measures

Primary Outcomes (1)

• Agreement between measurements of P-tau217 concentration in blood samples from Tasso device and venipuncture

  Day 1

Secondary Outcomes (5)

• 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

Study Arms (1)

Blood draw using IV and at home device

OTHER

Device: Tasso Lancet Device

Interventions

Tasso Lancet Device DEVICE

blood samples will be obtained from all participants using Tasso device

Blood draw using IV and at home device

Eligibility Criteria

• Age: 55 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Insight Research Institute: lead

Study Sites (2)

Insight Research Institute/Insight Hospital and Medical Center Chicago

Chicago, Illinois, 60616, United States

Location

Insight Research Institute

Flint, Michigan, 48507, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: October 1, 2024
• Study Start: September 19, 2024
• Primary Completion: December 7, 2024
• Study Completion: December 7, 2024
• Last Updated: February 11, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

US (2)