Investigation of Inflammation in Alzheimer's Disease and Related Dementias (ADRD) Using [11C]-CS1P1

Description

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.

Conditions

Alzheimer Disease

Study Overview

Study Details

Study overview

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.

Investigation of Inflammation in Alzheimer's Disease and Related Dementias (ADRD) Using [11C]-CS1P1

Investigation of Inflammation in Alzheimer's Disease and Related Dementias (ADRD) Using [11C]-CS1P1

Condition
Alzheimer Disease
Intervention / Treatment

-

Contacts and Locations

Saint Louis

Washington University School of Medicine, Saint Louis, Missouri, United States, 63110

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

50 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Washington University School of Medicine,

Tammie Benzinger, PRINCIPAL_INVESTIGATOR, Washington University School of Medicine

Study Record Dates

2026-05