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

Suspended

Phase 2 Results N/A

Trial Description

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.

Trial Stopped: Study halted prematurely prior to initiation but potentially will resume

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: Non-active capsules for inhalation.
    ARM 1: Kind: Experimental
    Label: Placebo
    Description: ALZT-OP1a: placebo capsule for oral inhalation via dry powder inhaler, taken twice per day (morning and evening), 8-12 hours apart.
  • CROMOLYN Drug
    Other Names: Cromolyn sodium
    Intervention Desc: Active capsules for inhalation.
    ARM 1: Kind: Experimental
    Label: ALZT-OP1a
    Description: ALZT-OP1a: cromolyn (17.1 mg, capsule) for oral inhalation via dry powder inhaler, taken twice per day (morning and evening), 8-12 hours apart.

Outcomes

Type Measure Time Frame Safety Issue
Primary Montreal Cognitive Assessment (MoCA) Baseline and Week 12
Secondary Mini Mental State Examination (MMSE) Baseline and Week 12

Sponsors