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

Age range

50–86 years

Sex

All

Healthy volunteers

No

Interventions

• Drug
  Interleukin-2

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

• Drug
  Placebo

  Placebo administration

Location