drugset / Trial / NCT00895895

Study Comparing 3 Dosage Levels Of SAM-531 In Outpatients With Mild To Moderate Alzheimer Disease

NCT00895895

Phase 2 Terminated 526 enrolled Pfizer
RandomizedParallel-groupTriple-blindTreatment

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

Drugs

EvaluationDrugModalityDoseRoute
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

Indications