Recruiting

[11C]-CS1P1

Sponsor:

Washington University School of Medicine

Code:

NCT06129838

Conditions

Alzheimer Disease

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Accepted

Interventions

[11C]-CS1P1

Study Details

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 older adults and with cognitively impaired older adults.

Conditions

Alzheimer Disease

Study ID

NCT06129838

Start date

May 5, 2023

Status verified date

Jun, 2026

Completion date

May, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

80 participants

Anticipated

Interventions and Outcome Measures

Arms

Healthy participants

Healthy participants will receive a single intravenous bolus injection of 12.0 - 17.0 milliCurie (mCi) of the investigational radiotracer \[11C\]-CS1P1. Participants will then undergo a brain \[11C\]-CS1P1 PET scan

Participants with cognitive impairment (Alzheimer's disease)

Participants with cognitive impairment will receive a single intravenous bolus injection of 12.0 - 17.0 milliCurie (mCi) of the investigational radiotracer \[11C\]-CS1P1. Participants will then undergo a brain \[11C\]-CS1P1 PET scan

Interventions

[11C]-CS1P1

Participants will receive a single intravenous bolus injection of 12.0 - 17.0 milliCurie (mCi) of the investigational radiotracer \[11C\]-CS1P1. Participants will then undergo a brain \[11C\]-CS1P1 PET scan

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Jayashree Rajamanickam

314 273 6140jayashree.r@wustl.edu

Kelley Jackson

314 362 3613kelleyj@wustl.edu

Locations

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Jayashree Rajamanickam

314-273-6140jayashree.r@wustl.edu

Kelley Jackson

314 362 3613kelleyj@wustl.edu

More Information

Sponsor

Washington University School of Medicine

Last update posted

Jun 9, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-06-09.