Alzheimer DiseaseHASD_PIB_INDNCT04579120
Neuroimaging in Healthy Aging and Senile Dementia (HASD_IND)
An observational study of Alzheimer Disease, run by Tammie L. S. Benzinger, MD, PhD at 1 site in United States.
Trial summary
To identify factors that signal the transition from asymptomatic (preclinical) to symptomatic Alzheimer disease (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 ([11C]PiB) and F 18 AV-1451 (Flortaucipir)
- Type of treatment
- Injection or infusion
- How many people
- 650 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2021to Dec 2027
- 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: Participants are referred from the Washington University Knight Alzheimer's Disease Research Center (ADRC). The ADRC is responsible for the recruitment, enrollment, and maintenance of the Total Registry (TR). The Knight ADRC primarily recruits participants by means of word of mouth and public service announcements from the greater metropolitan St. Louis area. A small percentage (~17%) of participants are referred by a Washington University physician.
Who may be able to join
- Male or female, any race
- Age > 18 years
- Participation in one of the ongoing projects affiliated with the Knight ADRC at Washington University and referred by the MAP staff and a Washington University physician.
- Normal cognition or early-stage symptomatic AD
- Willing and able to undergo study procedures.
- Capacity to give informed consent and follow study procedures
Who cannot join
- Has any condition that, in the Investigator's opinion, could increase risk to the participant, limit the participant's ability to tolerate the research procedures, or interfere with the collection/analysis of the data (e.g., participants with severe chronic back pain might not be able to lie still during the scanning procedures);
- Has hypersensitivity to either AV-1451 or 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;
- Currently pregnant or breast-feeding. Women must agree to avoid becoming pregnant and must agree to refrain from sexual activity or to use reliable contraceptive methods for 24 hours following administration of Flortaucipir injection;
- Must not have participated in any clinical trial involving a study drug or device within the 30-days prior to study enrollment;
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- Must not participate in another drug or device study prior to the end of this study participation;
- 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
Jasmin Chua, MS, 314-226-4197, chuajk@wustl.edu
About this study
To identify factors that signal the transition from asymptomatic (preclinical) to symptomatic Alzheimer disease (AD).
Read the detailed description
The purpose of this research study is to evaluate the structure and function of the brain in healthy aging and early Alzheimer's disease using positron emission tomography (PET), magnetic resonance imaging (MRI), and computed tomography (CT) imaging. The study involves 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).
This study will use radioactive tracers called C-11 Pittsburgh Compound B (PIB) and F 18/ AV-1451 (Flortaucipir) which binds to beta amyloid and tau in the brain. These compounds are considered investigational, which means that they have not been approved by the United States Food and Drug Administration (FDA).
- Conditions
- Alzheimer Disease
- Being tested
- [11C]-Pittsburgh Compound B ([11C]PiB), F 18 AV-1451 (Flortaucipir)
- Keywords
- Dementia, Neuro-Degenerative Disease, Amyloid Plaque, Mild Cognitive Impairment, Brain Disease
- Medical subject headings
- Alzheimer Disease, Dementia, Plaque, Amyloid, Cognitive Dysfunction, Brain Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[11C]-Pittsburgh Compound B ([11C]PiB)Drug
Also called PiB
A dosage range between 6.0 - 20.0 mCi (222-740 MBq) is planned for [11C] PIB. A PET-certified medical professional will prepare and administer the [11C] PIB tracer. Prior to the administration, the dosage will be assayed in a dose calibrator and diluted with 0.9% sodium chloride (normal saline) up to a total 20 mL syringe volume. Participants will receive a maximum intravenous bolus injection of 20.0 mCi of [11C] PIB followed by a 10 mL 0.9% sodium chloride (normal saline) flush.
F 18 AV-1451 (Flortaucipir)Drug
Also called F 18 AV-1451
A dosage range between 6.5 - 10.0 mCi (240-370MBq) is planned for [18F] AV-1451. A PET-certified medical professional will prepare and administer the [18F] AV-1451tracer. Prior to the administration, the dosage will be assayed in a dose calibrator. The volume of 18F-AV-1451 dose should not be adjusted by adding normal saline to the syringe. Participants will receive a maximum intravenous bolus injection of 10.0 mCi of [18F] AV-1451 followed by a 10 mL flush of 0.9% sodium chloride (normal saline).
| Study group | Role | What they receive |
|---|---|---|
| African American | African American participants receiving [11C]-Pittsburgh Compound B ([11C]PiB) F 18 AV-1451 (Flortaucipir) for imaging. Receives: Drug: [11C]-Pittsburgh Compound B ([11C]PiB); Drug: F 18 AV-1451 (Flortaucipir) | |
| Non-Hispanic White | Non-Hispanic White participants receiving [11C]-Pittsburgh Compound B ([11C]PiB) F 18 AV-1451 (Flortaucipir) for imaging. Receives: Drug: [11C]-Pittsburgh Compound B ([11C]PiB); Drug: F 18 AV-1451 (Flortaucipir) |
What is being measured
The primary outcome is the main question the study is designed to answer.
AD Biomarkers seen on Amyloid PET at Baseline and Years 1, 2, and/or 3
This Project aims to identify factors that signal the transition from asymptomatic (preclinical) to symptomatic Alzheimer disease (AD). This will be done by comparing imaging biomarkers seen with amyloid PET and the tracer C-11 PIB at baseline to imaging biomarkers collected longitudinally, at years 1, 2, and/or 3.
Measured: 5 years
AD Biomarkers seen on Tau PET at Baseline and Years 1, 2, and/or 3
This Project aims to identify factors that signal the transition from asymptomatic (preclinical) to symptomatic Alzheimer disease (AD). This will be done by comparing imaging biomarkers seen with tau PET and the tracer Flortaucipir at baseline to imaging biomarkers collected longitudinally, at years 1, 2, and/or 3.
Measured: 5 years
AD Biomarkers seen on MRI at Baseline and Years 1, 2, and/or 3
This Project aims to identify factors that signal the transition from asymptomatic (preclinical) to symptomatic Alzheimer disease (AD). This will be done by comparing imaging biomarkers seen with MRI at baseline to imaging biomarkers collected longitudinally, at years 1, 2, and/or 3.
Measured: 5 years
Compare and Correlate Predictive Ability of Biomarkers Seen with Different Imaging Variables for Onset of Symptoms
This project aims to compare and correlate the predictive ability of baseline values and rates of change of molecular biomarkers of AD for onset of AD symptoms with other variables. Variables obtained in this project include: 1) volumetric MRI, 2) MRI measures of vascular burden, 3) functional MRI, 4) amyloid PET, and 5) tau PET.
Measured: 5 years
Secondary outcomes (2)
Compare and Correlate Predictive Ability of Biomarkers Seen with Other Types of Variables for Onset of Symptoms
This project aims to compare and correlate the predictive ability of baseline values and rates of change of molecular biomarkers of AD for onset of AD symptoms with other variables obtained through Knight ADRC data sharing, which include, 1) clinical (demographic information, socioeconomic status, Clinical Dementia Rating, etiology of cognitive disorder (when present), and comorbid disorders, including cardiovascular disease); 2) cross-sectional and longitudinal cognitive performance, 3) indicators of sleep disruption 4) APOE genotype and genetic variants associated with resilience novel CSF analytes of neurofilament light chain, neurogranin, and SNAP-25 as markers of axonal and synaptic injury.
Measured: 5 years
Disparities for molecular biomarkers of AD in non-Hispanic white (NHW) and African American (AA) older adults
The study will also focus on disparities for molecular biomarkers of AD in non-Hispanic white (NHW) and African American (AA) older adults. Aim 2 will compare the risk (or the hazard) of developing AD symptoms by race, and will treat death as a potential competing risk in the progression of dementia.
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 posted8 Oct 2020
- Study start1 Sep 2021
- Primary completionNov 2027 (estimated)
- Study completionDec 2027 (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
- 650 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
- NCT04579120
- Sponsor's protocol ID
- 201906009
- Acronym
- HASD_PIB_IND
- Status last verified
- Jun 2026
- First submitted
- 12 Aug 2020
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: We will share imaging data with other researchers. They may be doing research in areas similar to this research or in other unrelated areas. These researchers may be at Washington University, at other research centers and institutions, or industry sponsors of research. We may also share research data with large data repositories (a repository is a database of information) for broad sharing with the research community. If individual research data is placed in one of these repositories only qualified researchers, who have received prior approval from individuals that monitor the use of the data, will be able to look at your information. The shared information will not include names but may be linked by a global unique identifier (GUID) number.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroimaging in Healthy Aging and Senile Dementia (HASD_IND)
- ClinicalTrials.gov ID
- NCT04579120
- Acronym / sponsor ID
- HASD_PIB_IND / 201906009
- Conditions
- Alzheimer Disease
- Keywords
- Dementia, Neuro-Degenerative Disease, Amyloid Plaque, Mild Cognitive Impairment, Brain Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 650 participants (estimated)
- Lead sponsor
- Tammie L. S. Benzinger, MD, PhDUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 8 Oct 2020 (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.
To identify factors that signal the transition from asymptomatic (preclinical) to symptomatic Alzheimer disease (AD).
Detailed description
The purpose of this research study is to evaluate the structure and function of the brain in healthy aging and early Alzheimer's disease using positron emission tomography (PET), magnetic resonance imaging (MRI), and computed tomography (CT) imaging. The study involves 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).
This study will use radioactive tracers called C-11 Pittsburgh Compound B (PIB) and F 18/ AV-1451 (Flortaucipir) which binds to beta amyloid and tau in the brain. These compounds are considered investigational, which means that they have not been approved by the United States Food and Drug Administration (FDA).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| African American | – | Drug: [11C]-Pittsburgh Compound B ([11C]PiB), Drug: F 18 AV-1451 (Flortaucipir)African American participants receiving [11C]-Pittsburgh Compound B ([11C]PiB) F 18 AV-1451 (Flortaucipir) for imaging. |
| Non-Hispanic White | – | Drug: [11C]-Pittsburgh Compound B ([11C]PiB), Drug: F 18 AV-1451 (Flortaucipir)Non-Hispanic White participants receiving [11C]-Pittsburgh Compound B ([11C]PiB) F 18 AV-1451 (Flortaucipir) for imaging. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants are referred from the Washington University Knight Alzheimer's Disease Research Center (ADRC). The ADRC is responsible for the recruitment, enrollment, and maintenance of the Total Registry (TR). The Knight ADRC primarily recruits participants by means of word of mouth and public service announcements from the greater metropolitan St. Louis area. A small percentage (~17%) of participants are referred by a Washington University physician.
Key inclusion criteria (6 listed)
- Male or female, any race
- Age > 18 years
- Participation in one of the ongoing projects affiliated with the Knight ADRC at Washington University and referred by the MAP staff and a Washington University physician.
- Normal cognition or early-stage symptomatic AD
- Willing and able to undergo study procedures.
Key exclusion criteria (9 listed)
- Has any condition that, in the Investigator's opinion, could increase risk to the participant, limit the participant's ability to tolerate the research procedures, or interfere with the collection/analysis of the data (e.g., participants with severe chronic back pain might not be able to lie still during the scanning procedures);
- Has hypersensitivity to either AV-1451 or 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;
- Currently pregnant or breast-feeding. Women must agree to avoid becoming pregnant and must agree to refrain from sexual activity or to use reliable contraceptive methods for 24 hours following administration of Flortaucipir injection;
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 ([11C]PiB)Also: PiBA dosage range between 6.0 - 20.0 mCi (222-740 MBq) is planned for [11C] PIB. A PET-certified medical professional will prepare and administer the [11C] PIB tracer. Prior to the administration, the dosage will be assayed in a dose calibrator and diluted with 0.9% sodium chloride (normal saline) up to a total 20 mL syringe volume. Participants will receive a maximum intravenous bolus injection of 20.0 mCi of [11C] PIB followed by a 10 mL 0.9% sodium chloride (normal saline) flush. | Drug | African American, Non-Hispanic White |
| F 18 AV-1451 (Flortaucipir)Also: F 18 AV-1451A dosage range between 6.5 - 10.0 mCi (240-370MBq) is planned for [18F] AV-1451. A PET-certified medical professional will prepare and administer the [18F] AV-1451tracer. Prior to the administration, the dosage will be assayed in a dose calibrator. The volume of 18F-AV-1451 dose should not be adjusted by adding normal saline to the syringe. Participants will receive a maximum intravenous bolus injection of 10.0 mCi of [18F] AV-1451 followed by a 10 mL flush of 0.9% sodium chloride (normal saline). | Drug | African American, Non-Hispanic White |
Primary outcome
AD Biomarkers seen on Amyloid PET at Baseline and Years 1, 2, and/or 3
Time frame: 5 years
This Project aims to identify factors that signal the transition from asymptomatic (preclinical) to symptomatic Alzheimer disease (AD). This will be done by comparing imaging biomarkers seen with amyloid PET and the tracer C-11 PIB at baseline to imaging biomarkers collected longitudinally, at years 1, 2, and/or 3.
AD Biomarkers seen on Tau PET at Baseline and Years 1, 2, and/or 3
Time frame: 5 years
This Project aims to identify factors that signal the transition from asymptomatic (preclinical) to symptomatic Alzheimer disease (AD). This will be done by comparing imaging biomarkers seen with tau PET and the tracer Flortaucipir at baseline to imaging biomarkers collected longitudinally, at years 1, 2, and/or 3.
AD Biomarkers seen on MRI at Baseline and Years 1, 2, and/or 3
Time frame: 5 years
This Project aims to identify factors that signal the transition from asymptomatic (preclinical) to symptomatic Alzheimer disease (AD). This will be done by comparing imaging biomarkers seen with MRI at baseline to imaging biomarkers collected longitudinally, at years 1, 2, and/or 3.
Compare and Correlate Predictive Ability of Biomarkers Seen with Different Imaging Variables for Onset of Symptoms
Time frame: 5 years
This project aims to compare and correlate the predictive ability of baseline values and rates of change of molecular biomarkers of AD for onset of AD symptoms with other variables. Variables obtained in this project include: 1) volumetric MRI, 2) MRI measures of vascular burden, 3) functional MRI, 4) amyloid PET, and 5) tau PET.
2 secondary outcomes
Compare and Correlate Predictive Ability of Biomarkers Seen with Other Types of Variables for Onset of Symptoms
Time frame: 5 years
Disparities for molecular biomarkers of AD in non-Hispanic white (NHW) and African American (AA) older adults
Time frame: 5 years
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 8 Jun 2026.
- Individual participant dataSharing planned: No. We will share imaging data with other researchers. They may be doing research in areas similar to this research or in other unrelated areas. These researchers may be at Washington University, at other research centers and institutions, or industry sponsors of research. We may also share research data with large data repositories (a repository is a database of information) for broad sharing with the research community. If individual research data is placed in one of these repositories only qualified researchers, who have received prior approval from individuals that monitor the use of the data, will be able to look at your information. The shared information will not include names but may be linked by a global unique identifier (GUID) number.
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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 6 inclusion and 9 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 8 Jun 2026. 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, BA (314-362-1558, kelleyj@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AD Biomarkers seen on Amyloid PET at Baseline and Years 1, 2, and/or 3 (time frame: 5 years). The study lists 4 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 8 Jun 2026.