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NCT01254448 · ClinicalTrials.gov registry record · Phase 1
Multiple Ascending Dose Study of TC-5619 in Healthy Elderly Subjects and Subjects With Alzheimer's Disease
A Phase 1 study of Alzheimers Disease, sponsored by Targacept.
- Completed
- Registry status
- Phase 1
- Development phase
- 38
- Enrollment target
- 10
- Study locations
NCT01254448 is a Phase 1 study of Alzheimers Disease that has completed, run by Targacept. The registered enrollment target is 38 participants, below the 4,061-participant average among 142 other Alzheimers Disease trials with a reported enrollment target (99% lower). The trial reports 10 study locations across 6 states.
The verdict
NCT01254448, a Phase 1 study of Alzheimers Disease, has completed, sponsored by Targacept.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 38 participants
- Enrollment target
- 10
- Study locations
Study 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 Studied
Interventions
- DRUG Placebo
- DRUG TC-5619
Study Locations (10)
Florida
- MD Clinical - Hallandale
- Galiz Research - Miami Springs
- Comprehensive Phase One - Miramar
- Compass Research, LLC - Orlando
California
- Collaborative Neuroscience Network - Long Beach
- San Francisco Clinical Research Center - San Francisco
Georgia
- Atlanta Center For Clinical Research - Atlanta
New Jersey
- Princeton Medical Institutes - Princeton
Texas
- Community Clinical Research - Austin
Utah
- Aspen Clinical Research - Orem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2010-09 |
| Est. Completion | 2011-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01254448
The ClinicalTrials.gov registry entry for NCT01254448 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,061-participant average among 142 other Alzheimers Disease trials with a reported enrollment target (99% lower). The listed sponsor is Targacept, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Alzheimers Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01254448 reports 10 study locations spanning 6 distinct geographic areas - top geographies include Florida, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT01254448 about?
NCT01254448 is a clinical study titled "Multiple Ascending Dose Study of TC-5619 in Healthy Elderly Subjects and Subjects With Alzheimer's Disease". 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 incl...
What is the current status of trial NCT01254448?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 38 participants. The study started on 2010-09. Estimated completion is 2011-05.
What conditions does trial NCT01254448 study?
This clinical trial studies the following conditions: Alzheimers Disease.
What interventions are being tested in trial NCT01254448?
The interventions under investigation include: Placebo (DRUG), TC-5619 (DRUG).
Who is sponsoring clinical trial NCT01254448?
This trial is sponsored by Targacept, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01254448 being conducted?
This trial has 10 study locations across California, Florida, Georgia, New Jersey, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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