Alzheimer DiseaseACS_PIB_INDNCT04134923
Imaging Biomarkers in Preclinical and Symptomatic AD
An observational study of Alzheimer Disease, run by Tammie L. S. Benzinger, MD, PhD at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- [11C] Pittsburgh Compound-B (PIB)
- Type of treatment
- Injection or infusion
- How many people
- 375 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jun 2021to Oct 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Active participants currently enrolled in the Knight Alzheimer's Disease Research Center (ADRC) at Washington University.
Who may be able to join
- Male or female, any race;
- Age ≥ 18 years;
- Active participants currently enrolled in the Knight Alzheimer's Disease Research Center (ADRC) at Washington University.
Who cannot join
- Hypersensitivity to [11C] PIB or any of its excipients;
- Contraindications 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Lauren Ash, 314-273-6175, lash@wustl.edu
About this study
Official title: Imaging Biomarkers in Preclinical and Symptomatic AD. (ACS PiB IND)
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).
- Conditions
- Alzheimer Disease
- Being tested
- [11C] Pittsburgh Compound-B (PIB)
- Keywords
- Alzheimer's disease, neurology, radiology, Nuclear medicine
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[11C] Pittsburgh Compound-B (PIB)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| [11C] Pittsburgh Compound-B (PIB) | Using [11C] Pittsburgh Compound-B (PIB) to look for biomarkers in preclinical and symptomatic AD. Receives: Drug: [11C] Pittsburgh Compound-B (PIB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2019
- Study start8 Jun 2021
- Primary completionOct 2026 (estimated)
- Study completionOct 2029 (estimated)
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
- Other
- Time perspective
- Prospective
- Enrolment
- 375 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tammie L. S. Benzinger, MD, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tammie L. S. Benzinger, MD, PhD, Washington University School of Medicine
- Investigators
- Tammie Benzinger, MD, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04134923
- Sponsor's protocol ID
- 201906028
- Acronym
- ACS_PIB_IND
- Status last verified
- Aug 2025
- First submitted
- 18 Oct 2019
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging Biomarkers in Preclinical and Symptomatic AD. (ACS PiB IND)
- ClinicalTrials.gov ID
- NCT04134923
- Acronym / sponsor ID
- ACS_PIB_IND / 201906028
- Conditions
- Alzheimer Disease
- Keywords
- Alzheimer's disease, neurology, radiology, Nuclear medicine
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 375 participants (estimated)
- Lead sponsor
- Tammie L. S. Benzinger, MD, PhDUniversity, hospital or other
- Study start
- 8 Jun 2021 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 22 Oct 2019 (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.
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).
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).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [11C] Pittsburgh Compound-B (PIB) | – | Drug: [11C] Pittsburgh Compound-B (PIB)Using [11C] Pittsburgh Compound-B (PIB) to look for biomarkers in preclinical and symptomatic AD. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Active participants currently enrolled in the Knight Alzheimer's Disease Research Center (ADRC) at Washington University.
Key inclusion criteria (3 listed)
- Male or female, any race;
- Age ≥ 18 years;
- Active participants currently enrolled in the Knight Alzheimer's Disease Research Center (ADRC) at Washington University.
Key exclusion criteria (7 listed)
- Hypersensitivity to [11C] PIB or any of its excipients;
- Contraindications 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [11C] Pittsburgh Compound-B (PIB)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. | Drug | [11C] Pittsburgh Compound-B (PIB) |
Primary outcome
develop an integrated timeline for the imaging changes which occur during the transition from asymptomatic to symptomatic AD
Time frame: 5 years
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Individual participant dataSharing planned: No
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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.
Tammie Benzinger, MD, PhD principal investigator
Washington University School of Medicine
1 site 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 Tammie L. S. Benzinger, MD, PhD at 1 site 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 3 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kelley Jackson (314-297-7602, kelleyj@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
develop an integrated timeline for the imaging changes which occur during the transition from asymptomatic to symptomatic AD (time frame: 5 years). 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 7 Aug 2025.