Investigating brain inflammation in Alzheimer's disease using a new imaging tracer
Investigation of Inflammation in Alzheimer's Disease and Related Dementias (ADRD) Using [11C]-CS1P1
This study is testing a new imaging tool to see if it can help spot brain inflammation in older adults, including those with Alzheimer's disease and related conditions.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Washington University School of Medicine Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (St Louis, Missouri) |
| Trial ID | NCT06129838 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the use of a novel radioactive tracer, [11C]-CS1P1, in positron emission tomography (PET) scans to identify inflammation in the brains of older adults. Participants will include both healthy older adults and those with cognitive impairments related to Alzheimer's disease and related dementias (ADRD). The study will compare the uptake of [11C]-CS1P1 in the brains of cognitively healthy individuals versus those diagnosed with ADRD to gather preliminary data on its potential as a biomarker for the disease.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 50 and older, both cognitively healthy and those with mild cognitive impairment or early dementia due to ADRD.
Not a fit: Patients with severe claustrophobia or those currently undergoing radiation therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of inflammation in Alzheimer's disease, potentially leading to improved diagnostic methods.
How similar studies have performed: While this approach is novel, similar studies using PET imaging for Alzheimer's disease have shown promise in understanding disease mechanisms.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
St Louis, Missouri
- Washington University School of Medicine — St Louis, Missouri, United States (Recruiting)
Study contacts
- Principal investigator: Tammie Benzinger — Washington University School of Medicine
- Study coordinator: Jayashree Rajamanickam
- Email: jayashree.r@wustl.edu
- Phone: 314 273 6140
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.