CClinicalTrials.gg
RecruitingNCT06129838Updated Jun 9, 2026

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

An observational study in Alzheimer Disease, sponsored by Washington University School of Medicine. Recruiting at 1 site in United States. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-09.

Sponsored by Washington University School of Medicine · Observational

From the registry’s dates

  • Started May 2023; still recruiting 3 years 5 months later.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
80
Ages
50 Years and older
Sex
All
01

Study 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.

Read the 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 (ADRD). Investigators will complete imaging of the brain and neck in older adults with normal cognition and those with clinically diagnosed cognitive impairment from ADRD to characterize [11C]-CS1P1 uptake in the brain. Investigators will compare the normal cognition participants to patients with ADRD to collect preliminary data that will subsequently test the hypothesis that [11C]-CS1P1 uptake is elevated in patients with ADRD.

02

Conditions studied

  • Alzheimer Disease

Browse trials for

03

In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.

This study's planned enrollment of 80 is below the median of 200 across 751 observational studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Washington University School of Medicine is the lead sponsor of 1,765 studies on the registry; 271 are open to participants now.

Of its 324 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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).

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

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
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
80 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

  • Drug[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

    Also known as: Sphingosine 1 Phosphate 1

06

What researchers measure

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.

    Time frame: Through study completion, an average of 1 year

07

Study locations

1 of 1 sites recruiting
  • Washington University School of Medicine
    St Louis, Missouri 63110, United States
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06129838
Lead sponsor
Washington University School of Medicine
Responsible party
Tammie L. S. Benzinger, MD, PhD (Professor of Radiology Division, Diagnostic Radiology Section, Neuroradiology, Washington University School of Medicine) — Principal investigator
First posted
Nov 13, 2023
Start date
May 5, 2023
Primary completion
May 2027 (estimated)
Completion
May 2027 (estimated)
Last update
Jun 9, 2026

Study contacts

Jayashree Rajamanickam
Contact
jayashree.r@wustl.edu
314 273 6140
Kelley Jackson
Contact
kelleyj@wustl.edu
314 362 3613
Tammie Benzinger
principal investigator · Washington University School of Medicine

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion