Clinical trial NCT06622135: Home Test for Measuring Plasma P-tau217 in Alzheimer's Disease
Official title: Development of a Home Test for Measuring Plasma P-tau217 in Alzheimer's Disease Using Tasso Lancet Device
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Alzheimer Disease
Healthy Subjects
Lead sponsor: Insight Research Institute
Sponsor class: OTHER
First posted: 2024-10-01
Enrollment: 16
Sex: ALL
Minimum age (years): 55
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Agreement between measurements of P-tau217 concentration in blood samples from Tasso device and venipuncture
timeFrame: Day 1
Secondary outcomes:
measure: Means of p-tau217 concentration in subjects with and without AD
timeFrame: Day 1
measure: Agreement between measurements of P-tau217 concentration by the ALZpath P-tau217 and Janssen P-tau217+ assays
timeFrame: Day 1
measure: Percentage of Tasso devices which are loss, damaged, or with inadequate blood volume for analysis
timeFrame: Day 1
measure: Mean fold-change of p-tau217 concentration in subjects with and without AD
timeFrame: Day 1
measure: Effect size of p-tau217 concentration in subjects with and without AD
timeFrame: Day 1
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Insight Research Institute/Insight Hospital and Medical Center Chicago
state: Illinois
city: Flint
country: United States
facility: Insight Research Institute
state: Michigan
Study officials:
References: