This study is designed as a Phase 2, open-label study investigating the safety, tolerability, and efficacy of XPro1595 in patients with Mild Alzheimer's Disease (AD) or Mild Cognitive Impairment (MCI). The planned dose is 1.0 mg/kg of XPro1595 for all subjects that completed a previous Phase 2 study with XPro1595.~There are two Phase 2 Studies that were previously set up, whose participants can subsequently join this OLE study. One Phase 2 Study (NCT05318976) is a randomized, placebo-controlled, double-blind clinical study where 201 (anticipated) participants receive XPro1595 and placebo (2:1 ratio) for 6 months (Week 1 to Week 24). This study targets patients with mild Alzheimer's Disease (AD). Participants who received the drug during this study, and subsequently join the OLE study, will be on XPro1595 for an additional 12 months (52 weeks). Their total exposure to XPro1595 will be up to 18 months (76 weeks).~The other Phase 2 Study (NCT05321498) is a randomized, placebo-controlled, double-blind clinical study where 60 (anticipated) participants receive XPro1595 and placebo (2:1 ratio) for 3 months (Week 1 to Week 12). This study targets patients with Mild Cognitive Impairment (MCI). Participants who received the drug during this study, and subsequently join the OLE study, will be on XPro1595 for an additional 15 months (64 weeks). Their total exposure to XPro1595 will be up to 18 months (76 weeks).
The goal of this Phase 2 Open-Label Extension (OLE) is to evaluate long-term safety, tolerability, and efficacy of XPro1595 on measures of cognition, function and brain quality in individuals with mild Alzheimer's Disease or MCI with biomarkers of inflammation.