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NCT00071721 · ClinicalTrials.gov registry record · Phase 3
Valproate in Dementia (VALID)
A Phase 3 study, sponsored by Alzheimer's Disease Cooperative Study (ADCS).
- Completed
- Registry status
- Phase 3
- Development phase
- 313
- Enrollment target
NCT00071721 is a Phase 3 study that has completed, run by Alzheimer's Disease Cooperative Study (ADCS). The registered enrollment target is 313 participants.
The verdict
NCT00071721, a Phase 3 study, has completed, sponsored by Alzheimer's Disease Cooperative Study (ADCS).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 313 participants
- Enrollment target
Study Summary
The purpose of this trial is to demonstrate whether valproate therapy delays the emergence of agitation and/or psychosis in outpatients with probable Alzheimer's disease (AD) who have not experienced agitation and psychosis in their illness. A secondary aim is to determine whether valproate therapy delays the progression of cognitive and functional measures of the illness. This trial will also assess the tolerability and safety of low-dose, long-term valproate therapy. Valproate, an anticonvulsant drug, was selected because of its possible symptomatic efficacy for agitation in AD, known safety profile in numerous clinical populations, and in view of recent data supporting its neuroprotective potential in AD.
Interventions
- DRUG Placebo
- DRUG Valproate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 313 participants |
| Start Date | 2003-10 |
| Est. Completion | 2009-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00071721
The ClinicalTrials.gov registry entry for NCT00071721 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 313 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alzheimer's Disease Cooperative Study (ADCS), which has 10 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00071721 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00071721 about?
NCT00071721 is a clinical study titled "Valproate in Dementia (VALID)". The purpose of this trial is to demonstrate whether valproate therapy delays the emergence of agitation and/or psychosis in outpatients with probable Alzheimer's disease (AD) who have not experienced agitation and psychosis in their illness. A secondary aim is to determine whether valproate therapy ...
What is the current status of trial NCT00071721?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 313 participants. The study started on 2003-10. Estimated completion is 2009-12.
What interventions are being tested in trial NCT00071721?
The interventions under investigation include: Placebo (DRUG), Valproate (DRUG).
Who is sponsoring clinical trial NCT00071721?
This trial is sponsored by Alzheimer's Disease Cooperative Study (ADCS), which has 10 total clinical trials registered on ClinicalTrials.gov.
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