Home Test for Alzheimer's Disease

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to develop a simple, at-home test to help diagnose Alzheimer's disease. Researchers seek to determine if a blood sample collected with the Tasso Lancet Device at home yields results similar to those from a clinic. Participants will compare these methods by using the device alongside traditional blood draws. It suits individuals diagnosed with Alzheimer's and healthy individuals without cognitive issues, who can use the device with or without a caregiver's assistance. As an unphased trial, this study offers participants the chance to contribute to innovative diagnostic methods that could simplify Alzheimer's testing for many.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking blood thinners (medications that prevent blood clots) or if your medical conditions are not well-controlled with your current medications.

What prior data suggests that the Tasso Lancet Device is safe for at-home blood sample collection?

Research shows that the Tasso Lancet Device provides a safe and easy method for collecting small blood samples. One study found that using this device to collect blood from a fingertip is safe and mostly painless. A tiny needle gently pricks the skin. The FDA has approved this device for taking blood samples, confirming it meets safety standards. Therefore, the Tasso Lancet Device is well-tolerated with a low risk of side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Tasso Lancet Device because it offers a convenient at-home blood collection method for Alzheimer's disease testing. Unlike traditional methods that require a visit to a clinic for an intravenous (IV) blood draw, this device allows individuals to collect blood samples themselves at home. This ease of use could make regular monitoring more accessible and less stressful for patients, potentially leading to earlier detection and better management of Alzheimer's disease.

What evidence suggests that the Tasso Lancet Device is effective for diagnosing Alzheimer's disease?

Studies have shown that the Tasso Lancet Device, which participants in this trial will use, effectively collects blood samples, achieving a success rate of over 90% in obtaining sufficient blood for testing. Research indicates that blood samples collected with this device match the quality of those taken by traditional methods, such as regular blood draws. The device is almost painless and easy to use, making it convenient for home use. This could make it a valuable tool for diagnosing Alzheimer's disease by measuring p-tau217, a marker often elevated in individuals with Alzheimer's. ^{1 6 7 8 9}

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06622135

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

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11713913/

Performance of 2 Point‐of‐Care Capillary Plasma ... Tasso+ devices were 90.3% successful in collecting >50uL whole blood, and TAPII devices were 86% successful. ... Ptau217 CSF measurements showed a ...

3. tassoinc.com tassoinc.com/press-releases

PRESS RELEASES The Tasso Mini device is FDA Class II Lancet 510(k)-cleared and CE Marked. “Dried blood samples offer many advantages for clinical trials and remote ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0009912025000943

Comparison of laboratory results and pain perception in ... Capillary BSC shows strong agreement with venous sampling for most lab parameters and reduces patient discomfort.

5. mdpi.com mdpi.com/2075-4418/15/15/1935

Evaluation of a Simplified Upper Arm Device for Vacuum ... The vacuum-assisted lancing devices have generally been found to be easy to use, nearly painless, and reliable in collecting 200–600 µL of capillary blood while ...

6. tassoinc.com tassoinc.com/

Tasso, Inc. The Tasso Mini device is a blood lancet that collects whole blood samples. Tasso Mini is ideal for applications requiring longitudinal or higher-frequency ...

7. isrctn.com isrctn.com/ISRCTN10792815

A study to compare low-volume blood sampling techniques ... TASSO OnDemand: this device sticks to the skin with a light adhesive. When the button is pressed, a vacuum forms and a lancet pricks the surface of the skin.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11135758/

Feasibility, acceptability, and safety of a novel device ... Conclusion. In summary, capillary blood collection using the Tasso-SST device appears to be an acceptable, safe, and relatively painless method ...

9. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf22/K221131.pdf

August 12, 2022 Tasso, Inc. Trish Kan Brown Director of ... The safety lancet is intended for capillary blood sampling. The Tasso+ is a single-use blood lancing device intended for obtaining microliter.