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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-19

Study Completion Date

2024-12-07

Brief Summary

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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.

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Detailed Description

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Conditions

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Alzheimer Disease Healthy Subjects

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Blood draw using IV and at home device

Group Type OTHER

Tasso Lancet Device

Intervention Type DEVICE

blood samples will be obtained from all participants using Tasso device

Interventions

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Tasso Lancet Device

blood samples will be obtained from all participants using Tasso device

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

55 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes