NCT06096090

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: The Methodist Hospital Research Institute · Academic / Other
• Sex: All
• Age: 50 Years – 86 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DRUG	Interleukin-2	Low dose Interleukin-2 (Aldesleukin) administration to expand Regulatory T cells
DRUG	Placebo	Placebo administration

Timeline

• Start date: 2022-01-01
• Primary completion: 2025-12-30
• Completion: 2025-12-30
• First posted: 2023-10-23
• Last updated: 2024-05-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study