NCT03202147

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

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: AZTherapies, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Ischemic Stroke
• Post-stroke Cognitive Impairment

Interventions

Type	Name	Description
DRUG	Cromolyn	Active capsules for inhalation.
OTHER	Placebo	Non-active capsules for inhalation.

Timeline

• Start date: 2023-12-01
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2017-06-28
• Last updated: 2022-03-03

Regulatory

• FDA-regulated drug study