Home Test for Measuring Plasma P-tau217 in Alzheimer's Disease
Megadott ok: Lack of Funding
Key facts
- Where
- Chicago és Flint, Egyesült ÁllamokSee the 2 sites
Where in Egyesült Államok
- Insight Research Institute/Insight Hospital and Medical Center ChicagoChicago, Egyesült ÁllamokNo longer taking part
- Insight Research InstituteFlint, Egyesült ÁllamokNo longer taking part
Trial details
- Who runs it
- Insight Research Institute
- Trial code
- NCT06622135
- Record updated
- 2025. február 11.
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: 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; 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); Participation in a clinical study within the 2 month.