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

Sponsor

Washington University School of Medicine (Other)

Overall Status

Recruiting

CT.gov ID

NCT06129838

Collaborator

(none)

Enrollment

Location

35.9

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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. The primary objective of this IND study is to further evaluate the [11C]-CS1P1 for PET imaging of S1P1 expression in healthy older adults and in adults with Alzheimer's disease and Related Dementia (ADRD). Investigators will complete imaging of the brain and neck in older adults with normal cognition and those with clinically diagnosed cognitive impairment from ADRD to characterize [11C]-CS1P1 uptake in the brain. Investigators will compare the normal cognition participants to patients with ADRD to collect preliminary data that will subsequently test the hypothesis that [11C]-CS1P1 uptake is elevated in patients with ADRD.

Condition or Disease	Intervention/Treatment	Phase
Alzheimer Disease	Drug: [11C]-CS1P1

Study Design

Study Type:

Observational

Anticipated Enrollment :

80 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

May 5, 2023

Anticipated Primary Completion Date :

May 1, 2026

Anticipated Study Completion Date :

May 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Healthy participants	Drug: [11C]-CS1P1 Participants will receive a single intravenous bolus injection of 12.0 - 17.0 milliCurie (mCi) of the investigational radiotracer [11C]-CS1P1. Participants will then undergo a brain [11C]-CS1P1 PET scan
Participants with cognitive impairment (Alzheimer's disease)	Drug: [11C]-CS1P1 Participants will receive a single intravenous bolus injection of 12.0 - 17.0 milliCurie (mCi) of the investigational radiotracer [11C]-CS1P1. Participants will then undergo a brain [11C]-CS1P1 PET scan

Arm

Intervention/Treatment

Healthy participants

Drug: [11C]-CS1P1

Participants will receive a single intravenous bolus injection of 12.0 - 17.0 milliCurie (mCi) of the investigational radiotracer [11C]-CS1P1. Participants will then undergo a brain [11C]-CS1P1 PET scan

Participants with cognitive impairment (Alzheimer's disease)

Drug: [11C]-CS1P1

Outcome Measures

Primary Outcome Measures

PET imaging studies of [11C]-CS1P1 in healthy control participants and participants with Alzheimer's Disease and measuring the uptake of [11C]-CS1P1 tracer. [Through study completion, an average of 1 year]
To test the hypothesis that specific binding of [11C]-CS1P1 is elevated in participants with ADRD compared to healthy normal control participants.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Washington University School of Medicine	Saint Louis	Missouri	United States	63110

Sponsors and Collaborators

Washington University School of Medicine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tammie L. S. Benzinger, MD, PhD, Professor of Radiology Division, Diagnostic Radiology Section, Neuroradiology, Washington University School of Medicine

ClinicalTrials.gov Identifier:

NCT06129838

Other Study ID Numbers:

CS1P1-ADRD

First Posted:

Nov 13, 2023

Last Update Posted:

Nov 13, 2023

Last Verified:

Nov 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Alzheimer Disease

Dementia

Inflammation

Study Results

No Results Posted as of Nov 13, 2023