Alzheimer Disease, Healthy Subjects
Conditions
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.
Interventions
DEVICETasso Lancet Device
blood samples will be obtained from all participants using Tasso device
Sponsors
Insight Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to 90 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Agreement between measurements of P-tau217 concentration in blood samples from Tasso device and venipuncture | Day 1 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed