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

Insight Research Institute

Status: Terminated

Conditions: Alzheimer Disease; Healthy Subjects

Treatments: Device: Tasso Lancet Device

Study type: Interventional

Funder types: Other

Identifiers

NCT06622135

STU24080011

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 55 to 90 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Blood draw using IV and at home device

Other group

Treatment:

Device: Tasso Lancet Device