ClinicalTrials.gg
RecruitingNCT04134923ACS_PIB_INDUpdated Aug 7, 2025

Imaging Biomarkers in Preclinical and Symptomatic AD

An observational study in Alzheimer Disease, sponsored by Tammie L. S. Benzinger, MD, PhD. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-07.

Sponsored by Tammie L. S. Benzinger, MD, PhD · Observational

From the registry’s dates

  • Started Jun 2021; still recruiting 5 years 5 months later.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
375
Ages
18 Years and older
Sex
All
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Study summary

The purpose of this research study is to evaluate adult children of parents with and without Alzheimer's disease which represent an ideal population for investigating the biological changes that precede the clinical onset of AD. The investigators will be imaging the brain to detect the presence of amyloid deposits (plaques in the brain). Amyloid is a protein that may be related to dementia of Alzheimer's disease (DAT).

Read the detailed description

This study will use a radioactive tracer called [11C]-Pittsburgh Compound B (11C]PIB), which is a tracer that binds to beta amyloid protein in the brain. This compound is considered investigational, which means that it has not been approved by the United States Food and Drug Administration (FDA).

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Conditions studied

  • Alzheimer Disease

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Keywords

  • Alzheimer's disease
  • neurology
  • radiology
  • Nuclear medicine
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In context

Alzheimer Disease

3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.

This study's planned enrollment of 375 is above the median of 200 across 814 observational studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Tammie L. S. Benzinger, MD, PhD is the lead sponsor of 11 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Active participants currently enrolled in the Knight Alzheimer's Disease Research Center (ADRC) at Washington University.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male or female, any race;
  • Age ≥ 18 years;
  • Active participants currently enrolled in the Knight Alzheimer's Disease Research Center (ADRC) at Washington University.

Exclusion criteria

Exclusion Criteria:

  • to [11C] PIB or any of its ;
  • to PET, CT or MRI (e.g. electronic medical devices, inability to lie still for extended periods) that make it unsafe for the individual to participate;
  • Severe claustrophobia;
  • Women who are pregnant or breast-feeding will be excluded from PIB PET participation;
  • Has any condition that, in the opinion of the Sponsor-Investigator or designee could increase risk to the subject, limit the subject's ability to tolerate the research procedures, or interfere with collection of the data;
  • Currently participating in any clinical trial which involves an active study medication or placebo within the past 30 days before scanning and up to 2-weeks past the imaging visit.
  • Current or recent (within 12 months prior to screening) participation in research studies involving radioactive agents such that the total research-related radiation dose to the participant in any given year would exceed the limits set forth in the U.S. Code of Federal Regulations (CFR) Title 21 Section 361.1. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=361.1
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
375 participants (estimated)
Patient registry
No

Groups and cohorts

  • [11C] Pittsburgh Compound-B (PIB)

    Using \[11C\] Pittsburgh Compound-B (PIB) to look for biomarkers in preclinical and symptomatic AD.

    Drug: [11C] Pittsburgh Compound-B (PIB)

Interventions

  • Participants will receive a single intravenous bolus injection of 6.0 - 20.0 mCi (222-740 MBq) of the investigational radiotracer \[11C\] PIB. Participants will then undergo a \[11C\] PIB PET/CT scan conducted in the Center for Clinical Imaging Research (CCIR) facility.

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What researchers measure

Primary outcomes

  1. develop an integrated timeline for the imaging changes which occur during the transition from asymptomatic to symptomatic AD

    the annual rate of CDR progression will accelerate due to the aging of the ACS cohort., and estimate that among \~375 ACS participants who either remain CDR 0 currently and will continue to be clinically assessed or will be the new future enrollees, a total of 45 individuals will progress to CDR\>0 by the end of next funding cycle.

    Time frame: 5 years

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Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2021 (actual). Primary completion is estimated for Oct 2026, 64 months after the start.

Of 364 non-industry observational studies under Alzheimer Disease, half reached primary completion within 81 months of starting (the median), counting those still running; a quarter within 39 and three quarters within 203. This study's planned 64 months is below that.

Counting every sponsor, half of 405 studies reached it within 67 months; a quarter within 35 and three quarters within 171.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 18, 2019
First posted
Oct 22, 2019
StartActual
Jun 8, 2021
Primary completionEst.
Oct 2026
CompletionEst.
Oct 2029
Last update
Aug 7, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 7, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04134923
Lead sponsor
Tammie L. S. Benzinger, MD, PhD
Responsible party
Tammie L. S. Benzinger, MD, PhD (Professor of Radiology, Neuroradiology Section Professor of Neurological Surgery Director, Knight Alzheimer Research Imaging Program, Washington University School of Medicine) — Sponsor-investigator
First posted
Oct 22, 2019
Start date
Jun 8, 2021
Primary completion
Oct 2026 (estimated)
Completion
Oct 2029 (estimated)
Last update
Aug 7, 2025

Study contacts

Kelley Jackson
Contact
kelleyj@wustl.edu
314-297-7602
Tammie Benzinger, MD, PhD
principal investigator · Washington University School of Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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