Phosphorylated Tau Levels in Donated Blood
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Alzheimer&Amp;#39;s Disease. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Detection of Elevated Plasma pTau217 in Donated Human Blood Samples: Implications for Blood Transfusion Safety
Overview
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.
Detailed 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
Primary outcome measures
- Tau and pTau [Time frame: 6 months.]
- Concentration of pTau217 and Tau [Time frame: 6 months.]
Eligibility criteria
Inclusion criteria
- The plasma sample from donators.
Exclusion criteria
- None.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Other
Study locations
United States · 1 center
- University of Texas Health Science Center at Houston — Houston
Publications
- 40. Tatebe H, Kasai T, Ohmichi T, et al. Quantification of plasma phosphorylated tau to use as a biomarker for brain Alzheimer pathology: pilot case-control studies including patients with Alzheimer's disease and down syndrome. Mol Neurodegener. Sep 4 2017;12(1):63. doi:10.1186/s13024-017-0206-8 41. Mielke MM, Hagen CE, Xu J, et al. Plasma phospho-tau181 increases with Alzheimer's disease clinical
Identifiers
NCT: NCT07157839 · HSC-MS-25-0343 · 5R01AG062509