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Investigating Brain Inflammation in Alzheimer's and Related Dementias

This study is looking into how brain inflammation might be connected to Alzheimer's disease (AD) and other dementias like Lewy Body Dementia (LBD). Researchers will use a special imaging scan called PET/CT with a substance called C-11 ER-176 to measure inflammation in the brain. They will also take a blood sample to look for markers of inflammation and genetic factors. The goal is to see if brain inflammation is linked to amyloid-beta (AB) plaques (a hallmark of AD), cognitive decline, or other inflammation markers in the blood. You may be able to join if you are 60 or older and meet specific criteria related to your cognitive status and previous neurological evaluations.

Study design
This interventional study plans to enroll 125 participants. It is not specified if it is randomized, blinded, or what phase it is in.
What's involved
Participants will receive a one-time administration of C-11 ER-176 and undergo a PET/CT scan. You may be invited for an additional administration and scan. You will also have a one-time blood draw.
Compensation
Not stated in the trial record.
Follow-up
The study will track correlations between neuroinflammation and other factors for up to 4 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04786223

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

Enrolling by Invitation
PHASE2Ages 60+InterventionalDiagnostic
Val Lowe
~125 participants
Updated 2026-05-22 on ClinicalTrials.gov
What's tested:C-11 ER-176Blood Test

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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.
Measured over 4 years
+2 more outcomes measured

Conditions

Lewy Body Dementia (LBD)
Alzheimer Dementia (AD)

Explore related trials

Alzheimer's DiseaseLewy Body DementiaMild cognitive disorder

NCT04786223

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Mayo Clinic in Rochester

    Rochester, Minnesotano site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Val Lowe, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

Males or females 60 years of age or older.
Meet the requirements for one of the five groups (CU A-, CU A+, MCI A+, AD A+, MCI-LB or DLB).
Neurologic evaluation procedures with testing in the MCSA, ADRC, Longitudinal Imaging Biomarkers of Prodromal and Overt DLB studies or Mayo Clinic Behavioral Neurology Practice. Must have had or plan to have at least 2 testing sessions.
All participants must have or plan to have an amyloid PiB PET scan and MRI brain scan within approximately 6 months of the first ER176 PET/CT scan. Participants undergoing an optional additional ER176 scan are preferred, but not required, to have or plan to have an amyloid PiB PET scan and MRI brain scan within approximately 6 months of the second ER176 PET/CT scan.
Capacity to sign consent or have a legally authorized representative to sign the consent.

Exclusion

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).

What this trial measures

  • 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.4 years

    Rationale: Biomarkers that are surrogates of AD pathology are needed to provide methods to select appropriate treatment strategies. We hypothesize that increased neuroinflammation PET signal is seen in AD A+ and MCI A+ as compared to CU A+ participants and is also increased in CU A+ vs. CU A- participants. We note that similar patterns may also be observed in other neurodegenerative diseases such as DLB, particularly in cases with mixed AD pathology.

  • 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.).4 years

    Rationale: Surrogate biomarkers of AD pathology, beyond amyloid and tau, are needed to better assess disease progression and prognosis in AD dementia patients, as well as in DLB patients. We hypothesize that increased ER176 PET signal in amyloid positive participants is associated with the rate of cognitive decline preceding the neuroinflammation PET scan.

  • Determine if neuroinflammation, as measured by PET imaging, is associated with blood and/or CSF biomarkers of inflammation or other neurologic diseases and related blood tests.4 years

    Rationale: Plasma biomarkers are advantageous over imaging and CSF biomarkers with regards to cost, invasiveness, and feasibility in community settings. However, they may be less specific. We need to determine how blood and/or CSF biomarkers correlate with PET neuroinflammation imaging as markers of disease progression, which markers are most highly correlated, and which may be specific to AD pathology. We hypothesize that plasma biomarkers of inflammation and other neurologic diseases and related blood tests (cytokines, TSPO, amyloid and tau) will correlate with increased PET neuroinflammation imaging signal.