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Investigation of Inflammation in Alzheimer's Disease Using [11C]-CS1P1

This study is looking into brain inflammation in Alzheimer's disease and related dementias (ADRD). Researchers will use a special imaging technique called a PET scan with a new, investigational radioactive tracer called [11C]-CS1P1. This tracer helps them see inflammation in the brain. The study aims to compare how [11C]-CS1P1 is taken up in the brains of healthy older adults versus those with mild cognitive impairment or early dementia due to ADRD. The goal is to see if [11C]-CS1P1 uptake is higher in people with ADRD, which could help us understand the disease better. The study plans to enroll 80 participants and is currently recruiting.

Study design
This is an observational study comparing brain imaging results between healthy older adults and those with Alzheimer's disease and related dementias. It plans to enroll 80 participants.
What's involved
Participants will receive a single intravenous (into a vein) injection of [11C]-CS1P1 and then undergo a brain PET scan.
Compensation
Not stated in the trial record.
Follow-up
The primary imaging measurements will be taken through study completion, which is an average of 1 year.

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NCT06129838

Investigation of Inflammation in Alzheimer's Disease and Related Dementias (ADRD) Using [11C]-CS1P1

Recruiting
Not specifiedAges 50+Observational
Washington University School of Medicine
~80 participants
Updated 2026-06-09 on ClinicalTrials.gov
What's tested:[11C]-CS1P1

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
PET imaging studies of [11C]-CS1P1 in healthy control participants and participants with Alzheimer's Disease and measuring the uptake of [11C]-CS1P1 tracer.
Measured over Through study completion, an average of 1 year

Conditions

Alzheimer Disease

Explore related trials

Alzheimer's Disease

Where it's being run

1 sites across 1 states
Missouri1

Study leadership

  • Tammie Benzinger · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine

Who to contact

Jayashree Rajamanickam
[email protected]
314 273 6140
Email the study team

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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

What this trial measures

  • PET imaging studies of [11C]-CS1P1 in healthy control participants and participants with Alzheimer's Disease and measuring the uptake of [11C]-CS1P1 tracer.Through study completion, an average of 1 year

    To test the hypothesis that specific binding of \[11C\]-CS1P1 is elevated in participants with ADRD compared to healthy normal control participants.