Investigating brain inflammation in Alzheimer's disease using a new imaging tracer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.