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Cytokine Therapy

IL-2 every 2 weeks 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 36 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 36 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Methodist Hospital Research InstituteLead Sponsor

275 Previous Clinical Trials

80,505 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age bracket for participants in this medical study inclusive of individuals who are 80 years or older?

"Enrollment for this study is open to individuals over 50 years old but under the age of 86."

Answered by AI

What is the current number of individuals being enrolled in this research investigation?

"Indeed, the details on clinicaltrials.gov show that this investigation is currently in search of participants. The trial was initially disclosed on March 17th, 2023 and had its latest update on April 22nd, 2024. Specifically, it aims to enroll 40 individuals at one selected site."

Answered by AI

Are there any available openings for patients to participate in this study?

"According to details on clinicaltrials.gov, this investigation is currently in the process of identifying suitable participants. The trial was publicly listed on March 17th, 2023 and most recently revised on April 22nd, 2024."

Answered by AI

What is the safety profile of administering IL-2 biweekly to patients?

"Based on our assessment at Power, the safety rating for administering IL-2 biweekly is 2. This evaluation arises from being in a Phase 2 trial where there is existing safety data but no confirmed efficacy data available."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Systemic and Central Inflammation in AD

2023. "Systemic and Central Inflammation in AD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06384378.

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