Status:
RECRUITING
Investigation of Inflammation in Alzheimer's Disease and Related Dementias (ADRD) Using [11C]-CS1P1
Lead Sponsor:
Washington University School of Medicine
Conditions:
Alzheimer Disease
Eligibility:
All Genders
50+ years
Brief Summary
This study involves a brain positron emission tomography (PET) scan with a new, investigational radioactive tracer called \[11C\]-CS1P1 to identify inflammation in the brain by testing with healthy ol...
Detailed Description
The primary objective of this IND study is to further evaluate the \[11C\]-CS1P1 for PET imaging of S1P1 expression in healthy older adults and in adults with Alzheimer's disease and Related Dementia ...
Eligibility Criteria
Inclusion
- Male or female, any race;
- Age ≥ 50 years;
- Capable of providing written informed consent OR having a legally authorized representative (LAR) to provide informed consent for volunteering to undergo research procedure;
- Additional inclusion for ADRD group: clinical diagnosis of mild cognitive impairment or early dementia due to ADRD, OR biomarker diagnosis of Alzheimer's disease, with or without symptoms.
Exclusion
- Hypersensitivity to \[11C\]-CS1P1 or any of its excipients;
- Contraindications to PET, CT, or MRI (e.g. certain incompatible electronic medical devices, inability to lie still for extended periods) that make it potentially unsafe for the individual to participate;
- Severe claustrophobia;
- Women who are currently pregnant or breast-feeding;
- Currently undergoing radiation therapy;
- Any condition that, in the opinion of the Sponsor-Investigator or designee could increase risk to the participant, limit the participant's ability to tolerate the research procedures or interfere with collection of the data (e.g., renal or liver failure, advanced cancer);
- Participants who in the last 6 months experienced any of the following cardiovascular conditions or findings in the screening electrocardiogram (ECG): clinically significant cardiac arrhythmias including high grade heart block (type 2 or greater), unstable angina, or decompensated heart failure requiring hospitalization or Class III/IV heart failure;
- Moderate to Severe anemia with Hemoglobin \< than 9.9 in both males and females.
- 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
Key Trial Info
Start Date :
May 5 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06129838
Start Date
May 5 2023
End Date
May 1 2027
Last Update
June 10 2025
Active Locations (1)
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1
Washington University School of Medicine
St Louis, Missouri, United States, 63110