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NCT00000174 · ClinicalTrials.gov registry record · Phase 3
Investigation Into Delay to Diagnosis of Alzheimer's Disease With Exelon (InDDEx)
A Phase 3 study, sponsored by Novartis.
- Completed
- Registry status
- Phase 3
- Development phase
NCT00000174 is a Phase 3 study that has completed, run by Novartis.
The verdict
NCT00000174, a Phase 3 study, has completed, sponsored by Novartis.
- COMPLETED
- Registry status
- Phase 3
- Development phase
Study Summary
This phase IIIb trial is a prospective, randomized, double-blind, placebo-controlled, 36-month study comparing the length of time of progression from mild cognitive impairment (MCI) to a clinical diagnosis of Alzheimer's disease (AD) in subjects taking Exelon vs. placebo. Exelon is currently under review with the U.S. Food and Drug Administration as a treatment for Alzheimer's disease. The drug has been cleared for marketing in more than 40 countries for Alzheimer's disease to date, including all 15 member states of the European Union, New Zealand, Argentina, Brazil and Mexico. Each subject with MCI will be randomly assigned to treatment with either Exelon or placebo. Subjects assigned to Exelon will receive 1.5 to 6.0 mg bid (twice daily) (3.0 to 12 mg/day) for the majority of the study. At every regular visit scheduled every three months, patients will be given basic efficacy and safety assessments. These assessments will include evaluation of adverse events, vital signs, activities of daily living, and clinical staging scales to determine if the subject may have converted to dementia.
Interventions
- DRUG Rivastigmine
Trial Details
| Field | Value |
|---|---|
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00000174
The ClinicalTrials.gov registry entry for NCT00000174 describes a study currently listed as completed, categorized as Phase 3. An enrollment target was not published in the registry record, which is common for early-stage or observational entries. The listed sponsor is Novartis, which has 265 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Rivastigmine is the first listed.
NCT00000174 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00000174 about?
NCT00000174 is a clinical study titled "Investigation Into Delay to Diagnosis of Alzheimer's Disease With Exelon (InDDEx)". This phase IIIb trial is a prospective, randomized, double-blind, placebo-controlled, 36-month study comparing the length of time of progression from mild cognitive impairment (MCI) to a clinical diagnosis of Alzheimer's disease (AD) in subjects taking Exelon vs. placebo. Exelon is currently under r...
What is the current status of trial NCT00000174?
This trial is currently completed. It is a Phase 3 study.
What interventions are being tested in trial NCT00000174?
The interventions under investigation include: Rivastigmine (DRUG).
Who is sponsoring clinical trial NCT00000174?
This trial is sponsored by Novartis, which has 265 total clinical trials registered on ClinicalTrials.gov.
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