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Safety and Efficacy of ALZT-OP1a as Adjuvant Treatment in Subjects With Post-Ischemic Stroke Cognitive Impairment (PSCI)

Ischemic Stroke Clinical Trial

Official title:
A Phase II Safety and Efficacy Study of ALZT-OP1a as Adjuvant Treatment in Subjects With Post-Ischemic Stroke Cognitive Impairment (PSCI)

Clinical Trial Summary

This is a Phase II, randomized, double-blinded, placebo-controlled study for subjects with evidence of PSCI.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03202147
Study type Interventional
Source AZTherapies, Inc.
Contact
Status Withdrawn
Phase Phase 2
Start date December 2023
Completion date December 2024
View Details
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