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NCT00506415 · ClinicalTrials.gov registry record · Phase 3
Comparative Efficacy, Safety, and Tolerability of Rivastigmine 10 and 15 cm^2 Patch in Patients With Alzheimer's Disease (AD) Showing Cognitive Decline
A Phase 3 study of Alzheimer Disease, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,584
- Enrollment target
- 20
- Study locations
NCT00506415: Completed Phase 3 study of Alzheimer Disease, sponsored by Novartis Pharmaceuticals.
NCT00506415 is a Phase 3 study of Alzheimer Disease that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 1,584 participants, below the 2,746-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (42% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00506415, a Phase 3 study of Alzheimer Disease, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,584 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study was to support the optimal use of rivastigmine patch in long-term treatment of Alzheimer's Disease in patients demonstrating functional and cognitive decline at the target maintenance dose of rivastigmine patch 10 cm\^2.
Primary Outcome
The Alzheimer's Disease Assessment Scale-Cognitive (ADAS-cog) subscale comprises 11 items summed to a total score ranging from 0 to 70, with lower scores indicating less severe impairment. A negative change indicates an improvement from baseline.
Conditions Studied
Interventions
- DRUG Rivastigmine 5 cm^2
- DRUG Rivastigmine 10 cm^2
- DRUG Rivastigmine 15 cm^2
- DRUG Placebo to 15 cm^2 patch
- DRUG Placebo to 10 cm^2 patch
Study Locations (20)
California
- Novartis investigative site - Anaheim
- Novartis investigative site - Carson
- Novartis investigative site - Costa Mesa
- Novartis investigative site - Fullerton
- Novartis investigative site - La Habra
- Novartis investigative site - La Jolla
- Novartis investigative site - National City
- Novartis investigative site - Redlands
- Novartis investigative site - San Francisco
Florida
- Novartis investigative site - Boca Raton
- Novartis investigative site - Bradenton
- Novartis investigative site - Deerfield Beach
- Novartis investigative site - Delray Beach
- Novartis investigative site - Fort Lauderdale
Arizona
- Novartis investigative site - Gilbert
- Novartis investigative site - Phoenix
- Novartis investigative site - Sun City
Colorado
- Novartis investigative site - Fort Collins
- Novartis investigative site - Longmont
Alabama
- Novartis investigative site - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,584 participants |
| Start Date | 2007-06 |
| Est. Completion | 2011-05 |
| Phase | Phase 3 |
What the finished NCT00506415 record still lists
NCT00506415 is an interventional study that assigns participants to a tested intervention. Its 1,584 participants enrollment target places it among the larger protocols in the corpus, below the 2,746-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (42% lower).
The record links to 1 condition, with Alzheimer Disease appearing as the primary indexed condition, and to 5 interventions - of which Rivastigmine 5 cm^2 is the first listed.
NCT00506415 names 20 study sites across 5 states, led by California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT00506415 about?
NCT00506415 is a clinical study titled "Comparative Efficacy, Safety, and Tolerability of Rivastigmine 10 and 15 cm^2 Patch in Patients With Alzheimer's Disease (AD) Showing Cognitive Decline". The purpose of this study was to support the optimal use of rivastigmine patch in long-term treatment of Alzheimer's Disease in patients demonstrating functional and cognitive decline at the target maintenance dose of rivastigmine patch 10 cm\^2.
What is the current status of trial NCT00506415?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,584 participants. The study started on 2007-06. Estimated completion is 2011-05.
What conditions does trial NCT00506415 study?
This clinical trial studies the following conditions: Alzheimer Disease.
What interventions are being tested in trial NCT00506415?
The interventions under investigation include: Rivastigmine 5 cm^2 (DRUG), Rivastigmine 10 cm^2 (DRUG), Rivastigmine 15 cm^2 (DRUG), Placebo to 15 cm^2 patch (DRUG), Placebo to 10 cm^2 patch (DRUG).
Who is sponsoring clinical trial NCT00506415?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00506415 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Alzheimer 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 NCT00506415's enrollment target sits among peer trials
1,584 25th of 306 higher than 282 of 306 other Alzheimer Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alzheimer 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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