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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: Completed Phase 1 study of Alzheimers Disease, sponsored by Targacept.
NCT01254448 is a Phase 1 study of Alzheimers Disease that has completed, run by Targacept. The registered enrollment target is 38 participants, below the 3,926-participant average among 147 other Alzheimers Disease trials with a reported enrollment target (99% lower). The trial reports 10 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Number of participants with treatment-emergent adverse events
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 |
What the finished NCT01254448 record still lists
NCT01254448 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 3,926-participant average among 147 other Alzheimers Disease trials with a reported enrollment target (99% lower).
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 lists 10 locations in 6 states (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.
Learn More About Clinical Trials
Similar trials for Alzheimers Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01254448's enrollment target sits among peer trials
38 110th of 147 higher than 38 of 147 other Alzheimers Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alzheimers Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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