Imaging Biomarkers in Preclinical and Symptomatic AD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: [11C] Pittsburgh Compound-B (PIB).
- Who it may be relevant to
- Registry conditions: Alzheimer Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Imaging Biomarkers in Preclinical and Symptomatic AD. (ACS PiB IND)
Overview
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.
Primary outcome measures
- develop an integrated timeline for the imaging changes which occur during the transition from asymptomatic to symptomatic AD [Time frame: 5 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
United States · 1 center
- Washington University School of Medicine — St Louis
Identifiers
NCT: NCT04134923 · 201906028