Targeting Neuroinflammation as a Contributing Pathology in Alzheimer's Disease Dementia

Val Lowe

Status and phase: Invitation-only; Phase 2

Conditions: Alzheimer Disease

Treatments: Diagnostic Test: Blood Test; Drug: C-11 ER-176

Study type: Interventional

Funder types: Other

Identifiers

NCT04786223

20-000866

Details and patient eligibility

About

This study is being done to research the usefulness of PET/CT imaging for measuring brain inflammation and its relation to Alzheimer's Disease. Additionally, researchers as looking to learn more about the side effects of a new radioactive tracer (radiotracer) C-11 ER176.

Full description

Alzheimer's disease (AD) dementia is a devastating illness with no cure. Treatments targeting known pathologic hallmarks of AD, such as amyloid-beta (AB), in symptomatic individuals have proved largely fruitless so other potential disease targets warrant exploration. Neuroinflammation has interesting possible associations with AD dementia and may contribute to AD dementia in different ways among different individuals. Previous PET neuroinflammation data are not entirely consistent and new methods of PET imaging and studies with larger cohorts are needed to further investigate the role of neuroinflammation in AD dementia and the utility of PET as a biomarker. This project seeks to test new PET neuroinflammation imaging methods in unimpaired and AD dementia individuals with biomarker-identified brain pathology to help address these gaps in knowledge in the field.

Enrollment: 100 estimated patients

Sex: All

Ages: 60 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males or females 60 years of age or older.
• Meet the requirements for one of the four groups (CU A-, CU A+, MCI A+, AD A+).
• Undergoing neurologic evaluation procedures with cognitive testing in the MCSA or - ADRC for a minimum of about 3 years.
• All participants must have had an amyloid PiB PET scan and MRI brain scan within the previous 6 months.
• Capacity to sign consent or have a legally authorized representative to sign the consent.

Exclusion criteria

• Participants unable to lie down without moving for 20 minutes.
• Women who are pregnant or cannot stop breast feeding for 24 hours.
• Actively taking daily anti-inflammatory medications (NSAIDs, corticosteroids, etc.) except for a small control group.
• Generalized inflammatory condition and treatment with immunosuppressive, corticoid/glucocorticoid, steroidal or non-steroidal anti-inflammatory medication within 2 weeks of scanning (only acute medication use as an exclusion so as to limit medication interaction but preserve possible chronic systemic inflammation interaction).
• Standard safety exclusionary criteria for MRI such as metallic foreign bodies, pacemaker, etc., since the quantitative PET data analysis is based on anatomic criteria that are established uniquely for each subject by registration to his/her MRI.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

C-11 ER176 PET/CT

Other group

Description:

C-11 ER176 is an investigational radiopharmaceutical that will be produced under cGMP in the Mayo Clinic Cyclotron Facility. The imaging agent (C-11 ER176) will be administered on an outpatient basis. It will be administered at a single time IV prior to the PET imaging.

Treatment:

Drug: C-11 ER-176

Diagnostic Test: Blood Test