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A Phase II Safety and Efficacy Study of ALZT-OP1a as Adjuvant Treatment in Subjects With Post-Ischemic Stroke Cognitive Impairment (PSCI)
This is a Phase II, randomized, double-blinded, placebo-controlled study for subjects with evidence of PSCI.
Details
| Lead sponsor | AZTherapies, Inc. |
|---|---|
| Phase | Phase 2 |
| Status | WITHDRAWN |
| Start date | 2023-12 |
| Completion | 2024-12 |
Conditions
- Ischemic Stroke
- Post-stroke Cognitive Impairment
Interventions
- Cromolyn
- Placebo
Primary outcomes
- Montreal Cognitive Assessment (MoCA) — 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.