Skip to content

Imaging Biomarkers in Preclinical and Symptomatic AD

Imaging Biomarkers in Preclinical and Symptomatic AD. (ACS PiB IND)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04134923
Acronym
ACS_PIB_IND
Enrollment
375
Registered
2019-10-22
Start date
2021-06-08
Completion date
2029-10-31
Last updated
2025-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease

Keywords

Alzheimer's disease, neurology, radiology, Nuclear medicine

Brief 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).

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).

Interventions

DRUG[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.

Sponsors

Tammie L. S. Benzinger, MD, PhD
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

* 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

Design outcomes

Primary

MeasureTime frameDescription
develop an integrated timeline for the imaging changes which occur during the transition from asymptomatic to symptomatic AD5 yearsthe 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.

Countries

United States

Contacts

Primary ContactKelley Jackson
kelleyj@wustl.edu314-297-7602

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026