Alzheimer DiseaseDraw-10NCT06742944
Draw-10: A Weekly Blood Draw Study to Understand the Biological Variability of Plasma pTau-217
An observational study of Alzheimer Disease, run by Banner Health at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Jan 2025to 30 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Arizona residents
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Banner Alzheimer's Institute
Phoenix, Arizona, 85006
Banner Alzheimer's Institute Tucson
Tucson, Arizona, 85718
About this study
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.
Read the detailed description
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.
- Conditions
- Alzheimer Disease
- Keywords
- plasma pTau217
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluctuations in plasma pTau217 biomarker results
Assess within participant changes in plasma pTau217 biomarker assay levels over the course of the study
Measured: 9 weeks
Frequency of large unknown biomarkers spike
Determine the frequency of large, unknown biomarkers spike that would influence a clinical decision.
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start27 Jan 2025
- Primary completion27 Aug 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Banner Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Jessica B Langbaum, PhD, Principal investigator, Banner Alzheimer's Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06742944
- Sponsor's protocol ID
- API-0002
- Other IDs
- R01AG058468
- Acronym
- Draw-10
- Status last verified
- Dec 2025
- First submitted
- 16 Dec 2024
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: study dataset and biological samples will be shared with qualified investigators
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Draw-10: A Weekly Blood Draw Study to Understand the Biological Variability of Plasma pTau-217
- ClinicalTrials.gov ID
- NCT06742944
- Acronym / sponsor ID
- Draw-10 / API-0002
- Conditions
- Alzheimer Disease
- Keywords
- plasma pTau217
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Banner HealthUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 27 Jan 2025 (actual)
- Primary completion
- 27 Aug 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 19 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Arizona residents
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Frequency of large unknown biomarkers spike
Time frame: 9 weeks
Determine the frequency of large, unknown biomarkers spike that would influence a clinical decision.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Individual participant dataSharing planned: Yes. study dataset and biological samples will be shared with qualified investigators
Related trials for Alzheimer Disease
RecruitingObservational study
PET Imaging in the Baltimore Longitudinal Study of Aging (BLSA)
Aging
Active, not recruiting
The PorchLight Project
Memory Loss, Alzheimer Disease
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Active, not recruitingPhase 2
Study to Evaluate the Efficacy, Safety, and Tolerability of an Anti-MTBR Tau Monoclonal Antibody (BMS-986446) in Participants With Early Alzheimer's Disease
Alzheimer Disease, Early Onset
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica B Langbaum, PhD principal investigator
Banner Alzheimer's Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease, run by Banner Health at 2 sites 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 5 inclusion and 2 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: finished, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fluctuations in plasma pTau217 biomarker results (time frame: 9 weeks). 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?
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 9 Dec 2025.