Central and Peripheral Immune Cross-talk in Alzheimer's Disease and Their Modulation by a Novel Immunotherapy
Inflammation could provide a new focus for therapeutic intervention. In this study, we will measure blood and cerebrospinal fluid (CSF) inflammation biomarkers and compare them to measurements of brain glial activation obtained by positron emission tomography (PET). In addition, we will determine the effect of low-dose interleukin-2 (IL-2) immunotherapy, given over 22 weeks, on these inflammation biomarkers.
• Diagnosis of probable Alzheimer disease according to National Institute on Aging-Alzheimer's Association (NIA-AA) criteria
• Male or female age 50 to 86 years
• MMSE between 12-26
• Total bilirubin less than or equal to 1.5mg/dL
• Alanine aminotransferase level (ALT) and aspartate aminotransferase (AST) less than or equal to two times normal,
• Albumin greater than or equal to 3.0mg/dL
• Serum creatinine less than or equal to 1.5 mg/dL
• White Blood Count (WBC) \>3,500/mm3; platelets \>100,000/mm3; hematocrit (HCT) \>32%.
• 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.
⁃ English language speaking
⁃ Formal education of eight or more years
⁃ Stable pharmacological treatment of any other chronic conditions for at least 30 days prior to screening