Phase II Clinical Trial of Interleukin-2 in AD
Trial Parameters
Brief 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 Criteria
Inclusion Criteria: 1. Diagnosis of probable Alzheimer disease according to National Institute on Aging-Alzheimer's Association (NIA-AA) criteria 2. Male or female age 50 to 86 years 3. MMSE between 12-26 4. Total bilirubin less than or equal to 1.5mg/dL 5. Alanine aminotransferase level (ALT) and aspartate aminotransferase (AST) less than or equal to two times normal, 6. Albumin greater than or equal to 3.0mg/dL 7. Serum creatinine less than or equal to 1.5 mg/dL 8. White Blood Count (WBC) \>3,500/mm3; platelets \>100,000/mm3; hematocrit (HCT) \>32%. 9. INR\<1.4 If on medications affecting cognition (rivastigmine, galantamine, donepezil, memantine), participants must be on stable dosage for at least 4 weeks prior to screening and should remain at a stable dosage during the course of the study. 10. English language speaking 11. Formal education of eight or more years 12. Stable pharmacological treatment of any other chronic conditions for at least 30 days prior to screening Exclusion C