Clinical trial NCT04786223: Targeting Neuroinflammation as a Contributing Pathology in Alzheimer's Disease Dementia
Official title: Targeting Neuroinflammation as a Contributing Pathology in Alzheimer's Disease Dementia
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE2
Conditions: Alzheimer Disease
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-03-08
Enrollment: 100
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Alzheimer's Disease Dementia
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Determine if neuroinflammation, as measured by C-11 ER176 SUVr and inflammatory blood test measurements, is correlated with an increase in AB plaque, as measured by C-11 PiB SUVr.
timeFrame: 4 year
measure: Determine if neuroinflammation, as measured by C-11 ER176 SUVr, is correlated with a history of increased cognitive decline in the 5 years preceding PET imaging, as measured by z scores from neuropsychiatric test results (memory, etc.).
timeFrame: 4 year
measure: Determine if neuroinflammation, as measured by PET imaging, is associated with plasma biomarkers of inflammation.
timeFrame: 4 year
Secondary outcomes:
measure: Incidence of adverse events attributable to ER176.
timeFrame: 4 year
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Val Lowe, MD
role: PRINCIPAL_INVESTIGATOR
References: