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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-30

Study Completion Date

2026-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Alzheimer Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Alzheimer's Disease Dementia

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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C-11 ER176 PET/CT

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.

Group Type OTHER

C-11 ER-176

Intervention Type DRUG

Participants will receive a one-time administration of C-11 ER176 and undergo a PET/CT imaging study. Blood samples for plasma biomarker testing will be obtained as part of the study.

Blood Test

Intervention Type DIAGNOSTIC_TEST

Participants will undergo a one time venipuncture blood collection to evaluate the presence of inflammatory and genetic markers.

Interventions

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C-11 ER-176

Participants will receive a one-time administration of C-11 ER176 and undergo a PET/CT imaging study. Blood samples for plasma biomarker testing will be obtained as part of the study.

Intervention Type DRUG

Blood Test

Participants will undergo a one time venipuncture blood collection to evaluate the presence of inflammatory and genetic markers.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

Minimum Eligible Age

60 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No