Draw-10: A Weekly Blood Draw Study to Understand the Biological Variability of Plasma pTau-217

NCT06742944 | Completed

• 2 other identifiers: API-0002R01AG058468
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

This is an observational study that will serially collect 10 plasma samples over the course of 9 weeks from the same individuals to assess fluctuations in blood biomarker results.

Conditions

Alzheimer Disease

Keywords

plasma pTau217

Outcome Measures

Primary Outcomes (2)

• Fluctuations in plasma pTau217 biomarker results

  Assess within participant changes in plasma pTau217 biomarker assay levels over the course of the study

  9 weeks

• Frequency of large unknown biomarkers spike

  Determine the frequency of large, unknown biomarkers spike that would influence a clinical decision.

  9 weeks

Study Arms (1)

Participants age 50-80 with normal cognition or mild impairment

All participants will provide 10 plasma samples over the course of 9 weeks. This is an observational cohort study (no intervention(s) administered)

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Arizona residents

You may qualify if:

• able and wiling to provide informed consent
• Aged 50-80 years old at the time of signing study consent; participants aged 50-59 years will be no more than 20% of the total study population
• Has normal cognition or mild impairment at screening MoCA by a score of greater than or equal to 18; participants with a Montreal Cognitive Assessment (MoCA Test) score between 18-25 will be no more than 20% of the total study population
• able and wiling to fully comply with study procedures defined in the protocol
• Written and spoken fluency in English

You may not qualify if:

• Plans to begin any new treatment or is having surgery during the 9-week draw timeframe
• Currently enrolled in a clinical trial using an investigational drug

Sponsors & Collaborators

• Banner Health: lead
• National Institute on Aging (NIA): collaborator

Study Sites (2)

Banner Alzheimer's Institute

Phoenix, Arizona, 85006, United States

Location

Banner Alzheimer's Institute Tucson

Tucson, Arizona, 85718, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

frozen plasma blood samples

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Jessica B Langbaum, PhD

  Banner Alzheimer's Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: December 19, 2024
• Study Start: January 27, 2025
• Primary Completion: August 27, 2025
• Study Completion: November 30, 2025
• Last Updated: December 9, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will be shared within 12 months after study completion

Locations

US (2)