Phosphorylated Tau Levels in Donated Blood

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:

• To compare pTau217 concentrations with total Tau to assess biomarker distribution in donated blood.
• 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

Inclusion criteria

• The plasma sample from donators.

Exclusion criteria

• None.