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Completed

NCT Number: NCT06742944

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

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.

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Banner Alzheimer's Institute, Phoenix, Arizona, United States

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About this study

Blood biomarkers offer a less invasive and cheaper method for identifying Alzheimer's disease (AD)-related changes. Already, blood biomarkers for AD are being adopted by clinical practice and their use will only expand in coming years. However, blood biomarkers are susceptible to fluctuations not yet well characterized. Such fluctuations, although rarely observed in current research settings, may influence the biological evaluation of dementia once implemented into routine settings. The study at present aims to identify how blood biomarkers fluctuate over a short period of time in the same individual and assess drivers of these fluctuations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Fluctuations in plasma pTau217 biomarker results

    Time frame: 9 weeks

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

  2. Frequency of large unknown biomarkers spike

    Time frame: 9 weeks

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

Sponsors and collaborators

Lead sponsor

Banner Health

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Acronym: Draw-10

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 19, 2024
Registry last updated
Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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