Study Comparing 3 Dosage Levels Of SAM-531 In Outpatients With Mild To Moderate Alzheimer Disease
Summary
The study will evaluate the efficacy and safety of an investigational drug called SAM-531 at three dosage levels. Subjects will receive either one of the 3 dosage levels of SAM-531, donepezil or placebo for the first 24 weeks of the study (period I). Subjects who receive placebo for period I will be assigned to receive the highest dose of SAM-531 SAM-531 for the remaining 28 weeks of the study, while subjects who received one of the three SAM-531 dosage levels or donepezil in period I will continue with the same study drug (period II).
Timeline
- Start
- 2009-05
- Primary completion
- 2011-05
- Completion
- 2011-05
Outcome
Missed primary endpoint
Stopped: “See termination reason in detailed description.”
registry Placebo, Then SAM-531 vs SAM-531 (1.5 mg); p = 0.424; Mean Difference (Final Values) 0.7 (95% CI -1.0 to 2.3) NCT00895895 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CERLAPIRDINE | Small molecule | 1.5 mg | Oral |
| Subject | CERLAPIRDINE | Small molecule | 3 mg | Oral |
| Subject | CERLAPIRDINE | Small molecule | 5 mg | Oral |
| Comparator | Donepezil | Small molecule | 10 mg | Oral |