Home Test for Alzheimer's Disease

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Insight Research Institute

Must not be taking: Anticoagulants, Antiplatelets

Disqualifiers: Bleeding disorders, Skin allergies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

16 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for individuals with Alzheimer's Disease and healthy subjects to develop a home test for AD diagnosis. Participants must be able to use the Tasso Lancet Device at home to collect their blood sample.

Inclusion Criteria

Subject able to comply with study procedures

I am between 55 and 90 years old.

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)

Exclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Blood Sample Collection

Participants use an FDA approved device for at home blood sample collection to measure p-tau217 levels

1-2 weeks

1 visit (in-person) for initial setup, multiple at-home collections

Follow-up

Participants are monitored for safety and effectiveness after blood sample collection

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Tasso Lancet Device

Trial Overview The study tests if the Tasso Lancet Device can accurately measure p-tau217 levels in blood samples taken at home, compared to standard venipuncture methods used in medical facilities.

How Is the Trial Designed?

Group I: Blood draw using IV and at home device Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Insight Research Institute

Lead Sponsor

Trials

1

Recruited

20+