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Alzheimer&Amp;#39;s DiseasepTIDBNCT07157839

Phosphorylated Tau Levels in Donated Blood

An observational study of Alzheimer&Amp;#39;s Disease, run by The University of Texas Health Science Center, Houston at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Alzheimer&Amp;#39;s Disease
How many people
250 participants
Where
1 siteUnited States
Study dates
28 Aug 2025to 1 Nov 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: Anybody who can donate blood.

Who may be able to join

  • The plasma sample from donators.

Who cannot join

  • None.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Zhongcong Xie, M.D., Ph.D. contact

17135006207

Zhongcong.Xie@uth.tmc.edu

United States1 site, 1 recruiting

  • University of Texas Health Science Center at Houston

    Houston, Texas, 77030

    Zhongcong Xie, 7135006207, Zhongcong.Xie@uth.tmc.edu

    Xian Li, M.D.

    Recruiting

Other trials in United States

About this study

Official title: Detection of Elevated Plasma pTau217 in Donated Human Blood Samples: Implications for Blood Transfusion Safety

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.

Read the 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

Keywords
Phosphorylated Tau, donated blood, Alzheimer's disease

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tau and pTau

    Concentration of Tau and pTau217 in plasma.

    Measured: 6 months.

  2. Concentration of pTau217 and Tau

    We will use nanoneedle technology to measure the concentration of Tau and pTau217 in collected plasma samples from blood donators.

    Measured: 6 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Sep 2025
  2. Study start28 Aug 2025
  3. Primary completion1 Nov 2026 (estimated)
  4. Study completion1 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Other
Enrolment
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07157839
Sponsor's protocol ID
HSC-MS-25-0343
Other IDs
5R01AG062509
Acronym
pTIDB
Status last verified
Feb 2026
First submitted
28 Aug 2025
Last updated
11 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: We do not know the names of any blood donators who provide samples of plasma.

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 severity and is associated with tau- and amyloid-positron emission tomography. Alzheimers Dement. Aug 2018;14(8):989-997. doi:10.1016/j.jalz.2018.02.013 42. Janelidze S, Mattsson N, Palmqvist S, et al. Plasma P-tau181 in Alzheimer's disease: relationship to other biomarkers, differential diagnosis, neuropathology and longitudinal progression to Alzheimer's dementia. Nat Med. Mar 2020;26(3):379-386. doi:10.1038/s41591-020-0755-1 43. Karikari TK, Pascoal TA, Ashton NJ, et al. Blood phosphorylated tau 181 as a biomarker for Alzheimer's disease: a diagnostic performance and prediction modelling study using data from four prospective cohorts. Lancet Neurol. May 2020;19(5):422-433. doi:10.1016/S1474-4422(20)30071-5 44. Palmqvist S, Insel PS, Stomrud E, et al. Cerebrospinal fluid and plasma biomarker trajectories with increasing amyloid deposition in Alzheimer's disease. EMBO Mol Med. Dec 2019;11(12):e11170. doi:10.15252/emmm.201911170 45. Palmqvist S, Janelidze S, Quiroz YT, et al. Discriminative Accuracy of Plasma Phospho-tau217 for Alzheimer Disease vs Other Neurodegenerative Disorders. JAMA. Aug 25 2020;324(8):772-781. doi:10.1001/jama.2020.12134 46. Janelidze S, Berron D, Smith R, et al. Associations of Plasma Phospho-Tau217 Levels With Tau Positron Emission Tomography in Early Alzheimer Disease. JAMA Neurol. Nov 9 2020;doi:10.1001/jamaneurol.2020.4201 47. Thijssen EH, La Joie R, Strom A, et al. Plasma phosphorylated tau 217 and phosphorylated tau 181 as biomarkers in Alzheimer's disease and frontotemporal lobar degeneration: a retrospective diagnostic performance study. Lan

Questions about this trial

What is this clinical trial studying?

An observational study of Alzheimer&Amp;#39;s Disease, run by The University of Texas Health Science Center, Houston at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Zhongcong Xie, M.D., Ph.D. (17135006207, Zhongcong.Xie@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tau and pTau (time frame: 6 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07157839, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.

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