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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
50 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests a new radioactive tracer called [11C]-CS1P1 with a PET brain scan to look for swelling and irritation in the brain, called inflammation. It is for adults age 50 or older who are healthy or have memory or thinking problems, including Alzheimer's disease and related dementias.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 50 or older, of any sex or race.
  • Able to give written consent to join, or have a legally authorized person give consent for you.
  • For the dementia group: have a diagnosis of mild memory or thinking problems or early dementia due to Alzheimer's disease or a related dementia, or have tests showing Alzheimer's disease, with or without symptoms.

Who can't join

  • Allergy to [11C]-CS1P1 or any of its ingredients.
  • Cannot safely have PET, CT, or MRI scans, such as because of certain medical devices or trouble lying still, or have a severe fear of small, closed spaces.
  • Currently pregnant or breastfeeding.
  • Currently getting radiation treatment.
  • A condition the study doctor believes could make the study unsafe, hard to tolerate, or affect the data, such as kidney or liver failure or advanced cancer.
  • Certain serious heart problems in the past 6 months or found on a screening heart test (ECG), including serious abnormal heart rhythms, unstable chest pain, or severe heart failure.
  • Moderate to severe anemia, meaning too little hemoglobin in the blood, with a hemoglobin level below 9.9.
  • Current participation, or participation within 12 months before screening, in research using radioactive substances that would put your yearly research radiation exposure above federal limits.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

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