This Phase II study is designed as a randomized, double-blinded, placebo-controlled study for subjects with evidence of PSCI.~Subjects will be randomly assigned to the Group I arm (ALZT-OP1a adjuvant treatment), which will consist of ALZT-OP1a for inhalation, taken twice daily (morning and evening), OR the Group II placebo arm, which will consist of inhaled placebo, taken twice daily (morning and evening).~A minimum of 350 subjects will be randomized to receive one of two possible treatment assignments: ALZT-OP1a adjuvant treatment of active study drug or placebo.~To account for subject dropouts (estimated rate of 30%), it is anticipated that up to 500 (or 250 subjects per treatment arm) may be recruited and randomized, to achieve a minimum of 175 evaluable subjects per treatment arm.~Randomization assignments will be stratified by site to ensure balance by site.
This is a Phase II, randomized, double-blinded, placebo-controlled study for subjects with evidence of PSCI.