Phosphorylated Tau Levels in Donated Blood

NCT07157839 | Recruiting

• 2 other identifiers: HSC-MS-25-03435R01AG062509
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Alzheimer&Amp;#39;s Disease

Keywords

Phosphorylated Tau, donated blood, Alzheimer's disease

Outcome Measures

Primary Outcomes (2)

• Tau and pTau

  Concentration of Tau and pTau217 in plasma.

  6 months.

• 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.

  6 months.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Anybody who can donate blood.

You may qualify if:

• The plasma sample from donators.

You may not qualify if:

• None.

Sponsors & Collaborators

• National Institute on Aging (NIA): collaborator
• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

Related Publications (1)

• 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

  RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Donated plasma.

Study Officials

• Zhongcong Xie, M.D., Ph.D.

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

17135006207; Zhongcong.Xie@uth.tmc.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 28, 2025
• First Posted: September 5, 2025
• Study Start: August 28, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)