NCT04579120 · Tammie L. S. Benzinger, MD, PhD
Neuroimaging in Healthy Aging and Senile Dementia (HASD_IND)
(HASD_PIB_IND)
What this study is about
To identify factors that signal the transition from asymptomatic (preclinical) to symptomatic Alzheimer disease (AD).
View original scientific description
To identify factors that signal the transition from asymptomatic (preclinical) to symptomatic Alzheimer disease (AD).
Interventions
DRUG
[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.
DRUG
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 measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- St Louis, Missouri
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 8, 2026 · Source of record for eligibility and locations