Alzheimer DiseaseNCT06129838
Investigation of Inflammation in Alzheimer's Disease and Related Dementias (ADRD) Using [11C]-CS1P1
An observational study of Alzheimer Disease, run by Washington University School of Medicine at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- [11C]-CS1P1
- Type of treatment
- Injection or infusion
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2023to May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- 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);
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Jayashree Rajamanickam, 314-273-6140, jayashree.r@wustl.edu
Kelley Jackson, 314 362 3613, kelleyj@wustl.edu
About this study
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.
- Conditions
- Alzheimer Disease
- Being tested
- [11C]-CS1P1
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[11C]-CS1P1Drug
Also called Sphingosine 1 Phosphate 1
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: [11C]-CS1P1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start5 May 2023
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tammie L. S. Benzinger, MD, PhD, Washington University School of Medicine
- Investigators
- Tammie Benzinger, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06129838
- Sponsor's protocol ID
- CS1P1-ADRD
- Status last verified
- Jun 2026
- First submitted
- 1 Nov 2023
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Inflammation in Alzheimer's Disease and Related Dementias (ADRD) Using [11C]-CS1P1
- ClinicalTrials.gov ID
- NCT06129838
- Acronym / sponsor ID
- CS1P1-ADRD
- Conditions
- Alzheimer Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 5 May 2023 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 13 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy participants | – | Drug: [11C]-CS1P1Healthy 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) | – | Drug: [11C]-CS1P1Participants 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 |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [11C]-CS1P1Also: Sphingosine 1 Phosphate 1Participants 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 | Healthy participants, Participants with cognitive impairment (Alzheimer's disease) |
Primary outcome
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
To test the hypothesis that specific binding of [11C]-CS1P1 is elevated in participants with ADRD compared to healthy normal control participants.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tammie Benzinger principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jayashree Rajamanickam (314 273 6140, jayashree.r@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.