RecruitingPhase 2NCT06096090

Phase II Clinical Trial of Interleukin-2 in AD

A Phase II Clinical Trial of Interleukin-2 (IL-2) in Patients With Mild to Moderate Alzheimer's Disease

Sponsor

The Methodist Hospital Research Institute

Enrollment

40 participants

Start Date

Jan 1, 2022

Study Type

INTERVENTIONAL

Conditions

Alzheimer Disease

Summary

Neuroinflammation is a significant component of Alzheimer disease (AD). Our group recently demonstrated that regulatory T cells (Tregs) have a compromised phenotype and reduced suppressive function in AD patients, skewing the immune system toward a proinflammatory status and potentially contributing to disease progression. Low dose interleukin-2 (IL-2) is now viewed as a promising immunoregulatory drug with the capacity to selectively expand and restore functional Tregs. This study is a phase II, randomized, double-blind, placebo-controlled study to assess low dose IL-2 therapy in AD patients. Up to 40 Alzheimer's disease patients in the mild- to moderate clinical dementia stages (MMSE scores: 12-26) will be randomized to five-day-courses of subcutaneous IL-2 or placebo for a total of 6 months. We will evaluate the safety and tolerability of IL-2 treatment and the possible effects of IL-2 treatment on peripheral and central inflammation. The expected time participants will be in the study is 30 weeks.

Eligibility

Min Age: 50 YearsMax Age: 86 Years

Plain Language Summary

Simplified for easier understanding

This Phase II study is testing whether low-dose interleukin-2 (IL-2) — a protein that regulates the immune system — can slow the progression of Alzheimer's disease. The idea is that boosting a specific type of immune cell (regulatory T-cells) may help reduce brain inflammation, which is thought to contribute to Alzheimer's. **You may be eligible if...** - You are between 50 and 86 years old - You have been diagnosed with probable Alzheimer's disease - Your cognitive test score (MMSE) is between 12 and 26 - Your liver, kidney, and blood counts are within acceptable ranges - If on cognitive medications (like donepezil or memantine), you have been on a stable dose for at least 4 weeks **You may NOT be eligible if...** - You have significant liver, kidney, or blood problems outside accepted ranges - You have autoimmune disease, active cancer, or serious infections - You are on blood thinners with an INR above 1.4 - You are unable to comply with the study schedule Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGInterleukin-2

Low dose Interleukin-2 (Aldesleukin) administration to expand Regulatory T cells

DRUGPlacebo

Placebo administration

Locations(1)

Houston Methodist Research Institute

Houston, Texas, United States

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NCT06096090

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