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NCT00710684 · ClinicalTrials.gov registry record · Phase 2
A Study of SB-742457, Added to Donepezil for the Treatment of Mild-to-moderate Alzheimer's Disease
A Phase 2 study of Alzheimers Disease, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 682
- Enrollment target
- 20
- Study locations
NCT00710684: Completed Phase 2 study of Alzheimers Disease, sponsored by GlaxoSmithKline.
NCT00710684 is a Phase 2 study of Alzheimers Disease that has completed, run by GlaxoSmithKline. The registered enrollment target is 682 participants, below the 3,922-participant average among 147 other Alzheimers Disease trials with a reported enrollment target (83% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00710684, a Phase 2 study of Alzheimers Disease, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 682 participants
- Enrollment target
- 20
- Study locations
Study Summary
The study is designed to investigate the safety and efficacy of SB-742457 when added to stable donepezil treatment in subjects with mild-to-moderate Alzheimer's disease.
Primary Outcome
ADAS-cog assessed a range of cognitive abilities including memory, comprehension, orientation in time and place and spontaneous speech. Most items were evaluated by tests, but some were dependent on clinician ratings on a five point scale. There were in all 11 questions. Total scores were calculated as the sum of the individual components. Scores ranged from 0 to 70 with higher scores indicated greater dysfunction. The ADAS-Cog total score was the sum of the calculated scores for questions 1, 2,
Conditions Studied
Interventions
- DRUG Placebo
- DRUG SB-742457 15mg
- DRUG SB-742457 35mg
- DRUG donepezil 5-10mg
Study Locations (20)
Buenos Aires
- GSK Investigational Site - Ciudad Autonoma de Buenos Aires
- GSK Investigational Site - Ciudad Autonoma de Buenos Aires
- GSK Investigational Site - Ciudad de Buenos Aires
- GSK Investigational Site - La Plata
California
- GSK Investigational Site - Fresno
- GSK Investigational Site - Rancho Mirage
- GSK Investigational Site - San Francisco
Florida
- GSK Investigational Site - Hallandale
- GSK Investigational Site - Hialeah
Arizona
- GSK Investigational Site - Litchfield Park
New Jersey
- GSK Investigational Site - Paterson
New York
- GSK Investigational Site - Syracuse
North Carolina
- GSK Investigational Site - Winston-Salem
Ohio
- GSK Investigational Site - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 682 participants |
| Start Date | 2008-07-01 |
| Est. Completion | 2010-11-16 |
| Phase | Phase 2 |
What the finished NCT00710684 record still lists
NCT00710684 is an interventional study that assigns participants to a tested intervention. The registered 682 participants enrollment target is mid-sized for trials with a published cap, below the 3,922-participant average among 147 other Alzheimers Disease trials with a reported enrollment target (83% lower).
The record links to 1 condition, with Alzheimers Disease appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT00710684 names 20 study sites across 14 states, led by Buenos Aires, California, Florida.
Frequently Asked Questions
What is clinical trial NCT00710684 about?
NCT00710684 is a clinical study titled "A Study of SB-742457, Added to Donepezil for the Treatment of Mild-to-moderate Alzheimer's Disease". The study is designed to investigate the safety and efficacy of SB-742457 when added to stable donepezil treatment in subjects with mild-to-moderate Alzheimer's disease.
What is the current status of trial NCT00710684?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 682 participants. The study started on 2008-07-01. Estimated completion is 2010-11-16.
What conditions does trial NCT00710684 study?
This clinical trial studies the following conditions: Alzheimers Disease.
What interventions are being tested in trial NCT00710684?
The interventions under investigation include: Placebo (DRUG), SB-742457 15mg (DRUG), SB-742457 35mg (DRUG), donepezil 5-10mg (DRUG).
Who is sponsoring clinical trial NCT00710684?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00710684 being conducted?
This trial has 20 study locations across Arizona, California, Florida, New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00710684's enrollment target sits among peer trials
682 23rd of 147 higher than 125 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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