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Cytokine Therapy

IL-2 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

Male or female age 50 to 86 years

Diagnosis of probable Alzheimer disease according to National Institute on Aging-Alzheimer's Association (NIA-AA) criteria

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months treatment phase

Awards & highlights

Study Summary

This trial will test the effects of low-dose IL-2 therapy in 40 Alzheimer's patients to see if it can reduce inflammation and improve safety and tolerability.

Who is the study for?

This trial is for individuals aged 50-86 with mild to moderate Alzheimer's Disease (AD), as indicated by MMSE scores of 12-26. Participants must have a diagnosis according to NIA-AA criteria, speak English, and have at least eight years of education. They should be stable on current medications for other conditions and meet specific health requirements related to liver function, blood counts, and kidney function.Check my eligibility

What is being tested?

The study tests low dose Interleukin-2 (IL-2) against a placebo in AD patients. It's a phase II trial where participants are randomly assigned to receive either IL-2 or placebo via subcutaneous injections over six months. The aim is to assess the safety of IL-2 therapy and its effects on inflammation in both the brain and body.See study design

What are the potential side effects?

While not explicitly listed in the provided information, common side effects associated with low dose IL-2 may include reactions at the injection site, flu-like symptoms such as fever or chills, fatigue, rash, nausea, diarrhea; however individual experiences can vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 50 and 86 years old.

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I have been diagnosed with Alzheimer's disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months treatment phase

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months treatment phase

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months treatment phase for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

To assess the safety and the tolerability of IL-2 in AD patients

Secondary outcome measures

To investigate the impact of IL-2 administration on the blood Treg population in AD patients

Trial Design

3Treatment groups

Active Control

Placebo Group

Group I: Aldesleukin every 4 weeksActive Control1 Intervention

Group II: Aldesleukin every 2 weeksActive Control1 Intervention

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 enrollment still taking place for this experiment?

"Clinicaltrials.gov displays that this medical investigation is actively searching for participants, commencing from the initial posting date of January 1st 2022 and lastly revised on October 17th 2023."

Answered by AI

Am I an eligible participant for this experiment?

"Eligibility criteria for this clinical trial requires applicants to be between 50 and 86 years of age, with a confirmed diagnosis of alzheimer's disease. Approximately 40 candidates will be accepted into the experiment."

Answered by AI

What is the scope of enrollment for this experiment?

"Affirmative. According to clinicaltrials.gov, this research project is actively seeking participants; the trial was introduced on January 1st 2022 and last amended on October 17th 2023. 40 people are needed from a single medical centre for this study."

Answered by AI

Has the FDA given clearance for a cyclic dosing of Aldesleukin?

"Given the Phase 2 nature of this trial, with limited evidence in support of efficacy but some supporting safety, our team at Power has calculated Aldesleukin every 4 weeks to be a score of 2."

Answered by AI

To what extent is the recruitment for this medical study limited to individuals under 50 years old?

"This trial requires patients to be within the age bracket of 50-86. In comparison, there are 12 clinical trials for those younger than 18 and 537 studies available for people over 65 years old."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase II Clinical Trial of Interleukin-2 in AD

Alireza Faridar 2023. "Phase II Clinical Trial of Interleukin-2 in AD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06096090.

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