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)

Status Withdrawn

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. ;

Related Conditions & MeSH terms

• Cerebral Infarction
• Cognitive Dysfunction
• Ischemia
• Ischemic Stroke
• Post-stroke Cognitive Impairment
• Stroke

• NCT number: NCT03202147
• Study type: Interventional
• Source: AZTherapies, Inc.
• Status: Withdrawn
• Phase: Phase 2
• Start date: December 2023
• Completion date: December 2024