Multiple Ascending Dose Study of TC-5619 in Healthy Elderly Subjects and Subjects With Alzheimer's Disease
- Registration Number
- NCT01254448
- Lead Sponsor
- Targacept Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 38
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description TC-5619 TC-5619 Subjects will receive a TC-5619 orally once a day for 28 days (Group 1) or 10 days (Group 2). Placebo Placebo Subjects will receive a placebo capsule orally once a day for 28 days (Group 1) or 10 days (Group 2).
- Primary Outcome Measures
Name Time Method Number of Participants with Adverse Events as a Measure of Safety and Tolerability Group 1: screening, Days -14, Day -1, Days 1, 2, 3, 27-33; Group 2: Day -14, Day -1, Days 1 -14 Number of participants with treatment-emergent adverse events
- Secondary Outcome Measures
Name Time Method Pharmacokinetic profiles Group 1: Days 1, 2, 28-32; Group 2: Day 1, 2, 4, 8, 10-14 Plasma concentrations (pharmacokinetic profiles) of TC-5619-238 over time (Groups 1 \& 2) and urine (Group 2) samples after multiple doses
Markers of inflammation in cerebrospinal fluid Group 1: Days 1, 2, 28-32; Group 2: Day 1, 2, 4, 8, 10-14 Changes in markers of inflammation in cerebrospinal fluid (Group 1 only)
Markers of inflammation in plasma Group 1: Days 1, 2, 28-32; Group 2: Day 1, 2, 4, 8, 10-14 Dose related changes in markers of inflammation in plasma over time (Groups 1 \& 2)
Trial Locations
- Locations (10)
Collaborative Neuroscience Network
🇺🇸Long Beach, California, United States
MD Clinical
🇺🇸Hallandale Beach, Florida, United States
Atlanta Center For Clinical Research
🇺🇸Atlanta, Georgia, United States
Comprehensive Phase One
🇺🇸Miramar, Florida, United States
San Francisco Clinical Research Center
🇺🇸San Francisco, California, United States
Galiz Research
🇺🇸Miami Springs, Florida, United States
Compass Research, LLC
🇺🇸Orlando, Florida, United States
Princeton Medical Institutes
🇺🇸Princeton, New Jersey, United States
Community Clinical Research
🇺🇸Austin, Texas, United States
Aspen Clinical Research
🇺🇸Orem, Utah, United States