No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
50 and older
Sex
Any
Study type
Observational
Participants needed
80 (estimated)
Sponsor
Washington University School of Medicine · Other
Who this trial is looking for
This trial is looking for older adults to participate in a brain scan study. Participants will help test a new radioactive tracer that identifies inflammation in the brain.
Are You a Good Fit for This Trial?
You may be able to join if
I am 50 years old or older.
I can give my own consent or have someone to help me consent.
I have mild cognitive impairment or early dementia due to Alzheimer's Disease.
I have been diagnosed with Alzheimer's Disease by a doctor.
You may not be able to join if
I am allergic to CCS1P1 or its ingredients.
I have certain medical devices that could be unsafe for a PET scan.
I have severe claustrophobia.
I am currently pregnant or breast-feeding.
I am undergoing radiation therapy.
I have a serious health condition that could increase my risk in this study.
I have had serious heart problems in the past 6 months.
I have moderate to severe anemia.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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City
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Status
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…
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
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