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NCT Number: NCT04134923

Imaging Biomarkers in Preclinical and Symptomatic AD

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).

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location status: Recruiting

Location contact

Lauren Ash

CONTACT

[email protected]

314-273-6175

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

[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.

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kelley Jackson

CONTACT

[email protected]

314-297-7602

Sponsors and collaborators

Lead sponsor

Tammie L. S. Benzinger, MD, PhD

Other

Registry information

Official study title

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

Acronym: ACS_PIB_IND

Important dates

Study start
2021
Primary completion
2026
Study completion
2029
First posted
Oct 22, 2019
Registry last updated
Aug 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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