Home Blood Test Study Using the Tasso Lancet Device to Measure P-tau217 Levels in Alzheimers Disease and Related Conditions

What this Trial Is About

This observational study evaluates the measurement of blood p-tau217 levels, a biomarker related to Alzheimers disease, using a home-based Tasso lancet device compared to the standard venipuncture blood collection method. The study includes participants with Alzheimers disease confirmed by amyloid PET or cerebrospinal fluid tests, healthy individuals without cognitive impairment, and people with cognitive impairment not caused by Alzheimers disease who are amyloid-negative. Researchers aim to compare p-tau217 concentrations in these different groups to assess agreement between the two blood collection methods. Participants are divided into three groups those with Alzheimers disease confirmed by amyloid PET or CSF, healthy controls without cognitive impairment, and individuals with non-Alzheimers cognitive impairment confirmed to be amyloid-negative. Blood samples will be collected at home using the Tasso device and also by standard venipuncture for comparison. The study focuses on baseline measurements of p-tau217 concentration agreement between these two collection methods. During the study, participants will provide blood samples through both methods, with assistance and caregiver consent available if needed. The primary outcome measured is the agreement between p-tau217 levels in blood collected by the Tasso device and by venipuncture at baseline. The study plans to enroll adults aged 40 to 90 years and includes safety monitoring related to systemic health conditions and recent medical history. Overall participation involves blood collection and monitoring without therapeutic intervention.

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