drugset / Trial / NCT01254448

Multiple Ascending Dose Study of TC-5619 in Healthy Elderly Subjects and Subjects With Alzheimer's Disease

NCT01254448 ↗

Phase 1 Completed 38 enrolled Targacept Inc.
RandomizedSingle-groupTriple-blindDiagnostic

Summary

This is a Phase 1 study to examine the safety, tolerability and pharmacokinetics of TC-5619 in elderly subjects with and without Alzheimer's disease. Group 1 includes elderly subjects with Alzheimer's disease to receive TC-5619 or placebo for 28 days to evaluate safety and tolerability. Group 2 includes healthy elderly subjects in a dose escalation design to receive TC-5619 or placebo for 10 days to evaluate safety, tolerability and pharmacokinetics.

Timeline

Start
2010-09
Primary completion
2011-03
Completion
2011-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Bradanicline Small molecule 25 mg Oral
Subject Bradanicline Small molecule 50 mg Oral
Subject Bradanicline Small molecule 150 mg Oral

Indications