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Cytokine Therapy

11C-ER176 for Alzheimer's Disease

Phase 2
Recruiting
Research Sponsored by The Methodist Hospital Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of probable Alzheimer disease according to National Institute on Aging-Alzheimer's Association (NIA-AA) criteria
Male or female age 50 to 86 years
Must not have
Within 4 weeks of screening visit or during the course of the study, concurrent treatment with specific medications
Clinical or laboratory findings consistent with other primary degenerative dementia, other neurodegenerative condition, seizure disorder, history of infectious, metabolic or systemic diseases affecting the central nervous system, clinically significant abnormal T4 or TSH
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months

Summary

This trial will investigate how inflammation in the body and brain can be measured using blood and cerebrospinal fluid biomarkers. The study will also look at how a low dose of interleukin-

Who is the study for?
This trial is for individuals with Alzheimer's Disease. It aims to explore the role of inflammation in AD by measuring biomarkers in blood and CSF, and brain glial activation via PET scans. Participants will also receive low-dose IL-2 immunotherapy over 22 weeks.
What is being tested?
The study tests how a marker called 11C-ER176 used in PET scans can show brain inflammation. Additionally, it examines the effects of a treatment with low-dose interleukin-2 on inflammation markers in patients with Alzheimer's Disease.
What are the potential side effects?
Potential side effects are not specified but may include typical reactions to immunotherapies such as injection site reactions, flu-like symptoms, or changes in blood counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with Alzheimer's disease.
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I am between 50 and 86 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not taking certain medications during the study.
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I do not have other brain conditions like dementia or seizures, and my thyroid tests are normal.
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I have had significant brain injuries or conditions as seen in my past scans.
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I haven't taken any experimental drugs recently.
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I have had issues with my bowels, like blockages or bleeding that needed surgery.
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I have had or currently have hepatitis B or C.
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I have a history of serious lung problems.
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I cannot have a lumbar puncture due to health reasons.
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I am on long-term steroids or interferon.
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I do not have any serious infections or tuberculosis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Blood inflammation biomarker levels
CSF inflammation biomarker levels
Voxel-wise, regional and total brain TSPO VT/fP measured with 11C-ER176 PET

Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: IL-2 every 2 weeksActive Control1 Intervention
Aldesleukin every 2 weeks
Group II: IL-2 every 4 weeksActive Control1 Intervention
Aldesleukin every 4 weeks
Group III: PlaceboPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

The Methodist Hospital Research InstituteLead Sponsor
283 Previous Clinical Trials
81,548 Total Patients Enrolled
~16 spots leftby Dec 2025
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