Recruiting

Neuroimaging

Sponsor:

Tammie L. S. Benzinger, MD, PhD

Code:

NCT04579120

Conditions

Alzheimer Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

[11C]-Pittsburgh Compound B ([11C]PiB)

F 18 AV-1451 (Flortaucipir)

Study Details

Brief summary:

To identify factors that signal the transition from asymptomatic (preclinical) to symptomatic Alzheimer disease (AD).

Conditions

Alzheimer Disease

Study ID

NCT04579120

Start date

Sep 1, 2021

Status verified date

Jun, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Nov, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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;
  • 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

Study Design

Enrollment

650 participants

Anticipated

Interventions and Outcome Measures

Arms

African American

African American participants receiving \[11C\]-Pittsburgh Compound B (\[11C\]PiB) F 18 AV-1451 (Flortaucipir) for imaging.

Non-Hispanic White

Non-Hispanic White participants receiving \[11C\]-Pittsburgh Compound B (\[11C\]PiB) F 18 AV-1451 (Flortaucipir) for imaging.

Interventions

[11C]-Pittsburgh Compound B ([11C]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)

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).

Primary outcome measure

  • AD Biomarkers seen on Amyloid PET at Baseline and Years 1, 2, and/or 3 [ Time Frame: 5 years ]
  • AD Biomarkers seen on Tau PET at Baseline and Years 1, 2, and/or 3 [ Time Frame: 5 years ]
  • AD Biomarkers seen on MRI at Baseline and Years 1, 2, and/or 3 [ Time Frame: 5 years ]
  • Compare and Correlate Predictive Ability of Biomarkers Seen with Different Imaging Variables for Onset of Symptoms [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Kelley Jackson, BA

314-362-1558kelleyj@wustl.edu

Locations

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Jasmin Chua, MS

314-226-4197chuajk@wustl.edu

More Information

Sponsor

Tammie L. S. Benzinger, MD, PhD

Last update posted

Jun 8, 2026

Last verified

Jun, 2026

Keywords

  • Dementia
  • Neuro-Degenerative Disease
  • Amyloid Plaque
  • Mild Cognitive Impairment
  • Brain Disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Tammie L. S. Benzinger, MD, PhD on 2026-06-08.