NCT01254448

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

Two-Part, Sequential Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TC-5619-238 in Elderly Subjects With and Without Alzheimer's Disease

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Targacept Inc. · Industry
• Sex: All
• Age: 55 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	TC-5619	Group 1: 25 mg TC-5619 administered once daily for 28 days. Group 2: 50-150 mg TC-5619 administered once daily for 10 days.
DRUG	Placebo	Group 1: matching placebo administered once daily for 28 days. Group 2: matching placebo administered once daily for 10 days.

Timeline

• Start date: 2010-09-01
• Primary completion: 2011-03-01
• Completion: 2011-05-01
• First posted: 2010-12-06
• Last updated: 2013-09-04

Locations

10 sites across 1 country: United States