Safety and Efficacy of ALZT-OP1a as Adjuvant Treatment in Subjects With Post-Ischemic Stroke Cognitive Impairment (PSCI)
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|ClinicalTrials.gov Identifier: NCT03202147|
Recruitment Status : Suspended (Study halted prematurely prior to initiation but potentially will resume)
First Posted : June 28, 2017
Last Update Posted : June 28, 2017
|Condition or disease||Intervention/treatment||Phase|
|Ischemic Stroke Post-stroke Cognitive Impairment||Drug: Cromolyn Other: Placebo||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase II Safety and Efficacy Study of ALZT-OP1a as Adjuvant Treatment in Subjects With Post-Ischemic Stroke Cognitive Impairment (PSCI)|
|Study Start Date :||July 2016|
|Estimated Primary Completion Date :||August 2017|
|Study Completion Date :||November 2017|
Active Comparator: ALZT-OP1a
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.
Active capsules for inhalation.
Other Name: Cromolyn sodium
Placebo Comparator: Placebo
ALZT-OP1a: placebo capsule for oral inhalation via dry powder inhaler, taken twice per day (morning and evening), 8-12 hours apart.
Non-active capsules for inhalation.
- Montreal Cognitive Assessment (MoCA) [ Time Frame: Baseline and Week 12 ]The primary endpoint is the difference in performance in the ALZT-OP1a adjuvant treatment group compared to the placebo group, as quantified by the mean change from baseline to Week 12 scored on MoCA.
- Mini Mental State Examination (MMSE) [ Time Frame: Baseline and Week 12 ]The secondary endpoint is the difference in performance in the ALZT-OP1a adjuvant treatment group compared to the placebo group, as quantified by the mean change from baseline to week 12 in points scored on MMSE.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03202147
|Study Chair:||David R. Elmaleh, PhD||AZTherapies, Inc.|
|Study Director:||David A. Brazier, BS||AZTherapies, Inc.|