Phase II Clinical Trial of Interleukin-2 in AD

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.

Timeline

Start

2022-01-01

Primary completion

2025-12-30

Completion

2025-12-30

Publications

• Faridar A, Gamez N, Li D, Wang Y, Boradia R, Thome AD, Zhao W, Beers DR, Thonhoff JR, Nakawah MO, Roman GC, Volpi JJ, Toledo JB, George M, Davis CS, Pascual B, Grundman M, Masdeu JC, Appel SH. Low-dose interleukin-2 in patients with mild to moderate Alzheimer's disease: a randomized clinical trial. Alzheimers Res Ther. 2025 Jul 4;17(1):146. doi: 10.1186/s13195-025-01791-x.

Drugs

Indications