drugset / Trial / NCT02547818
Safety and Efficacy Study of ALZT-OP1 in Subjects With Evidence of Early Alzheimer's Disease
Phase 3
Completed
620 enrolled
AZTherapies, Inc.
APCER Life Sciences · collabKCAS Bio · collabPharma Consulting Group AB · collab
RandomizedFactorialQuadruple-blindTreatment
Summary
This is a global Phase III, randomized, double-blinded, placebo-controlled study for subjects with evidence of early AD. The protocol is designed to determine whether ALZT-OP1 combination treatment (ALZT-OP1a + ALZT-OP1b) will slow down, arrests, or reverse cognitive and functional decline, in subjects with evidence of early stage Alzheimer's disease (AD).
Timeline
- Start
- 2015-09-15
- Primary completion
- 2020-11-13
- Completion
- 2020-11-18
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | ALZT-OP1a | Unknown | — | Inhaled |
| Comparator | Ibuprofen | Small molecule | — | Oral |