Phosphorylated Tau Levels in Donated Blood (pTIDB)

The University of Texas System (UT)

Status: Enrolling

Conditions: Alzheimer&Amp;#39;s Disease

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT07157839

HSC-MS-25-0343

5R01AG062509 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

Alzheimer's disease (AD) is characterized by the accumulation of tau pathology, and blood-based biomarkers such as phosphorylated tau-217 (pTau217) have been identified as sensitive and specific predictors of AD risk. Recent studies suggest that individuals with elevated pTau217 levels may be at increased risk for developing AD and cognitive dysfunction. This observational study will examine donated human plasma samples to determine whether some units of donated blood contain abnormally elevated pTau217 concentrations. The overarching goal is to evaluate whether transfusion of blood with higher pTau217 may pose risks to recipients and whether such units should be avoided in clinical use.

Full description

Study Type:

Observational (Laboratory-based biomarker study; no human intervention)

Study Design:

• Model: Cross-sectional
• Time Perspective: Prospective
• Sample Source: Donated human blood plasma samples obtained through a blood bank
• Enrollment: ~250 plasma samples; ~20 plasma samples of AD patients and ~20 plasma samples of normal control participants, where are purchased from BioIVT (Westbury, NY, USA).

Official Title:

Observational Measurement of pTau217 in Donated Human Plasma Samples

Primary Objective:

To determine the prevalence of elevated plasma pTau217 levels in donated blood.

Secondary Objectives:

1. To compare pTau217 concentrations with total Tau to assess biomarker distribution in donated blood.
2. To generate preliminary data on whether pTau217 screening could be relevant to transfusion safety guidelines.

Primary Outcome Measure:

• Proportion of blood samples with plasma pTau217 levels exceeding the threshold established in published Alzheimer's disease biomarker studies (measured by nanoneedle biosensor or equivalent immunoassay).

• We will also establish the cut off values of pTau217 of plasma based on the data from 20 AD patients and 30 normal control participants.

  • Time Frame: At single sample collection

Secondary Outcome Measures:

• Ratio of pTau217 to total Tau across plasma samples
• Distribution of pTau217 levels in the donor population

Biospecimen Retention:

Samples will be analyzed for biomarker levels; aliquots may be stored for future biomarker validation studies.

Eligibility Criteria:

• Inclusion: De-identified human plasma samples from standard blood bank donations
• Exclusion: Samples failing quality control or insufficient volume

Study Population:

Approximately 250 de-identified donated plasma samples obtained from healthy adult blood donors.

Estimated Enrollment: 250 samples

Enrollment: 250 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• The plasma sample from donators.

Exclusion criteria

• None.