Alzheimer DiseaseCS1P1NCT04517552
Investigation of Inflammation Using [C-11]-CS1P1
An observational study of Alzheimer Disease, run by Tammie L. S. Benzinger, MD, PhD at 1 site in United States.
Trial summary
There is a compelling need for a noninvasive imaging approach to measure S1P1 in both preclinical models of diseases and humans. PET measures of S1P1 expression is critical for elucidating the pathophysiological roles of S1P1 in neuroinflammation and neurodegeneration. Read more about this study
- Who is it for?
- Ages 18 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
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2020to 8 Jul 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Aim 1: Dosimetry/ Safety Group Ten healthy adult volunteers (5 males and 5 females) will be recruited and undergo whole-body PET/CT imaging for assessing the safety, dosimetry and metabolism of [11C]-CS1P1. Aim 2: Feasibility Cohort Aim 2A will consist of 24 adult volunteers that will be recruited and scanned to characterize [11C] CS1P1 uptake on PET scans of the brain and cervical lymph nodes, to assess for radiolabeled metabolites. Up to 20 participants who have completed Aim 2A will continue with the collection of test-retest and safety data, Aim 2B. Ten healthy controls age and gender-matched to 10 participants with MS will be invited to return for repeat imaging for test-retest reliability not less than 7 days after and not more than 12 months after baseline imaging.
Who may be able to join
- Male or female, any race;
- Age ≥ 18 years;
- Capable of providing written informed consent for volunteering to undergo research procedures.
- Healthy volunteer or volunteer with a diagnosis of MS
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): unstable cardiac arrhythmias, myocardial infarction, unstable angina, stroke, transient ischemic attack or decompensated heart failure requiring hospitalization or Class III/IV heart failure;
- Must not have participated in any clinical trial involving a study drug or device within the 30-days prior to study enrollment;
- Must not participate in another drug or device study prior to the end of this study participation;
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
There is a compelling need for a noninvasive imaging approach to measure S1P1 in both preclinical models of diseases and humans. PET measures of S1P1 expression is critical for elucidating the pathophysiological roles of S1P1 in neuroinflammation and neurodegeneration. The relevance of S1P1 in clinical disease has become readily apparent with the FDA approval of the S1P1 modulator FTY720 (fingolimod) for treating relapsing-remitting MS (RR-MS). MS is a chronic autoimmune, inflammatory disease caused by lymphocytic infiltration that leads to demyelinating neurodegenerative disease.
Read the detailed description
The primary objective of the initial IND study is to determine the safety of the [11C]-CS1P1 for PET imaging of S1P1 expression. The investigators will first complete whole-body PET dosimetry studies in healthy adult normal volunteers to calculate the actual radiation dose of each human organ and determine the allowable dose for a human subject when receiving a single dose for a PET scan. Second, complete imaging of the brain and lymph nodes of the neck in a wide range of ages of healthy adult normal control participants, both male and females to characterize [11C]-CS1P1 uptake in the brain and radiolabeled metabolite will be completed. Finally, a comparison of the normal control participants to patients with multiple sclerosis (MS) will be completed.
- 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
Participants will receive a single intravenous bolus injection of 6.0 - 20.0 mCi (222-740 MBq) of the investigational radiotracer [11C] CS1P1. Participants will then undergo a [11C] CS1P1 PET/CT scan.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: [11C] CS1P1 | Not described Receives: Drug: [11C]-CS1P1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The tracer [11C]-CS1P1 will be injected for the first time into humans, using a dose range of 12-17 mCi for evaluations of safety, biodistribution, and dosimetry.
Whole-body PET/CT images (skull vertex to proximal thighs) will be obtained in 10 healthy volunteers (5 males and 5 females) for up to a maximum of 4 hours immediately following intravenous (IV) injection of 12-17 mCi of [11C]-CS1P1 (dosage range calculated from rodent dosimetry data extrapolated to humans).
Measured: 2 years
PET imaging studies of [11C]-CS1P1 in healthy normal control participants and human participants with multiple sclerosis.
We hypothesize that specific binding of [11C]-CS1P1 is elevated in participants with neuroinflammatory/neurodegenerative diseases of the CNS compared to healthy normal control participants.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2020
- Study start2 Nov 2020
- Primary completion1 Jul 2027 (estimated)
- Study completion8 Jul 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.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tammie L. S. Benzinger, MD, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tammie L. S. Benzinger, MD, PhD, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04517552
- Sponsor's protocol ID
- IRB #202001057
- Acronym
- CS1P1
- Status last verified
- Aug 2026
- First submitted
- 8 Jul 2020
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Inflammation Using [C-11]-CS1P1
- ClinicalTrials.gov ID
- NCT04517552
- Acronym / sponsor ID
- CS1P1 / IRB #202001057
- Conditions
- Alzheimer Disease
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tammie L. S. Benzinger, MD, PhDUniversity, hospital or other
- Study start
- 2 Nov 2020 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 8 Jul 2027 (estimated)
- First posted
- 18 Aug 2020 (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.
There is a compelling need for a noninvasive imaging approach to measure S1P1 in both preclinical models of diseases and humans. PET measures of S1P1 expression is critical for elucidating the pathophysiological roles of S1P1 in neuroinflammation and neurodegeneration. The relevance of S1P1 in clinical disease has become readily apparent with the FDA approval of the S1P1 modulator FTY720 (fingolimod) for treating relapsing-remitting MS (RR-MS). MS is a chronic autoimmune, inflammatory disease caused by lymphocytic infiltration that leads to demyelinating neurodegenerative disease.
Detailed description
The primary objective of the initial IND study is to determine the safety of the [11C]-CS1P1 for PET imaging of S1P1 expression. The investigators will first complete whole-body PET dosimetry studies in healthy adult normal volunteers to calculate the actual radiation dose of each human organ and determine the allowable dose for a human subject when receiving a single dose for a PET scan. Second, complete imaging of the brain and lymph nodes of the neck in a wide range of ages of healthy adult normal control participants, both male and females to characterize [11C]-CS1P1 uptake in the brain and radiolabeled metabolite will be completed. Finally, a comparison of the normal control participants to patients with multiple sclerosis (MS) will be completed.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: [11C] CS1P1 | – | Drug: [11C]-CS1P1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Aim 1: Dosimetry/ Safety Group Ten healthy adult volunteers (5 males and 5 females) will be recruited and undergo whole-body PET/CT imaging for assessing the safety, dosimetry and metabolism of [11C]-CS1P1. Aim 2: Feasibility Cohort Aim 2A will consist of 24 adult volunteers that will be recruited and scanned to characterize [11C] CS1P1 uptake on PET scans of the brain and cervical lymph nodes, to assess for radiolabeled metabolites. Up to 20 participants who have completed Aim 2A will continue with the collection of test-retest and safety data, Aim 2B. Ten healthy controls age and gender-matched to 10 participants with MS will be invited to return for repeat imaging for test-retest reliability not less than 7 days after and not more than 12 months after baseline imaging.
Key inclusion criteria (4 listed)
- Male or female, any race;
- Age ≥ 18 years;
- Capable of providing written informed consent for volunteering to undergo research procedures.
- Healthy volunteer or volunteer with a diagnosis of MS
Key exclusion criteria (10 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]-CS1P1Participants will receive a single intravenous bolus injection of 6.0 - 20.0 mCi (222-740 MBq) of the investigational radiotracer [11C] CS1P1. Participants will then undergo a [11C] CS1P1 PET/CT scan. | Drug | Experimental: [11C] CS1P1 |
Primary outcome
The tracer [11C]-CS1P1 will be injected for the first time into humans, using a dose range of 12-17 mCi for evaluations of safety, biodistribution, and dosimetry.
Time frame: 2 years
Whole-body PET/CT images (skull vertex to proximal thighs) will be obtained in 10 healthy volunteers (5 males and 5 females) for up to a maximum of 4 hours immediately following intravenous (IV) injection of 12-17 mCi of [11C]-CS1P1 (dosage range calculated from rodent dosimetry data extrapolated to humans).
PET imaging studies of [11C]-CS1P1 in healthy normal control participants and human participants with multiple sclerosis.
Time frame: 2 years
We hypothesize that specific binding of [11C]-CS1P1 is elevated in participants with neuroinflammatory/neurodegenerative diseases of the CNS 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 24 Aug 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Tammie L. S. Benzinger, MD, PhD 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 10 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: under way, not looking for participants, as of the sponsor's last update on 24 Aug 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The tracer [11C]-CS1P1 will be injected for the first time into humans, using a dose range of 12-17 mCi for evaluations of safety, biodistribution, and dosimetry. (time frame: 2 years). The study lists 2 primary outcomes in all. 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 24 Aug 2026.