Phase II Clinical Trial of Interleukin-2 in AD

Alzheimer Disease Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Alzheimer Disease

• NCT number: NCT06096090
• Study type: Interventional
• Source: The Methodist Hospital Research Institute
• Contact: Alireza Faridar, MD
• Phone: 7134411150
• Email: afaridar@houstonmethodist.org
• Status: Recruiting
• Phase: Phase 2
• Start date: January 1, 2022
• Completion date: December 30, 2025