NCT06129838 Investigation of Inflammation in Alzheimer's Disease and Related Dementias (ADRD) Using [11C]-CS1P1
| NCT ID | NCT06129838 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Washington University School of Medicine |
| Condition | Alzheimer Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 80 participants |
| Start Date | 2023-05-05 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 80 participants in total. It began in 2023-05-05 with a primary completion date of 2027-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Tammie Benzinger
PRINCIPAL INVESTIGATOR
Washington University School of Medicine
Frequently Asked Questions
Who can join the NCT06129838 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying Alzheimer Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06129838 currently recruiting?
Yes, NCT06129838 is actively recruiting participants. Contact the research team at jayashree.r@wustl.edu for enrollment information.
Where is the NCT06129838 trial being conducted?
This trial is being conducted at St Louis, United States.
Who is sponsoring the NCT06129838 clinical trial?
NCT06129838 is sponsored by Washington University School of Medicine. The principal investigator is Tammie Benzinger at Washington University School of Medicine. The trial plans to enroll 80 participants.
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