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

NCT06129838 | Recruiting DMC FDA Drug

• 1 other identifier: CS1P1-ADRD
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• PET imaging studies of [11C]-CS1P1 in healthy control participants and participants with Alzheimer's Disease and measuring the uptake of [11C]-CS1P1 tracer.

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

  Through study completion, an average of 1 year

Study Arms (2)

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

Drug: [11C]-CS1P1

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

Drug: [11C]-CS1P1

Interventions

[11C]-CS1P1 DRUG

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

Also known as: Sphingosine 1 Phosphate 1

Healthy participants; Participants with cognitive impairment (Alzheimer's disease)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All participants will be recruited from the community through the Volunteer for Health (VFH) Research Participant Registry at Washington University School of Medicine (WUSM), a research recruitment service offered by the Center for Clinical Studies Recruitment Enhancement Core at WUSM and through referrals from the Knight ADRC, MDC, and affiliated studies of memory and aging at Washington University, including affiliated Knight ADRC Research Imaging Program studies, referrals from physicians at Washington University and BJC Healthcare. The cohort will include healthy normal control participants and ADRD participants (n=80).

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood for future research

MeSH Terms

Conditions

Alzheimer Disease

Interventions

sphingosine 1-phosphate

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Tammie Benzinger

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jayashree Rajamanickam

CONTACT

314 273 6140; jayashree.r@wustl.edu

Kelley Jackson

CONTACT

314 362 3613; kelleyj@wustl.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Radiology Division, Diagnostic Radiology Section, Neuroradiology

Study Record Dates

• First Submitted: November 1, 2023
• First Posted: November 13, 2023
• Study Start: May 5, 2023
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: June 9, 2026

Record last verified: 2026-06

Locations

US (1)