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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: Completed Phase 3 study, sponsored by Alzheimer's Disease Cooperative Study (ADCS).
NCT00071721 is a Phase 3 study that has completed, run by Alzheimer's Disease Cooperative Study (ADCS). The registered enrollment target is 313 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (59% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
NPI quantifies behavioral changes in dementia, including depression, anxiety, psychosis, agitation, and others. This is a questionnaire administered to the subject's study partner. The range of this instrument is 0 to 120 with higher numbers indicating greater impairment. To determine whether or not psychosis or agitation is present, there is no cutoff score but is based on the clinician's judgment. In the NPI, the subject responds to 'Yes' or 'No' questions. Then it is determined how often psyc
Interventions
- DRUG Placebo
- DRUG Valproate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 313 participants |
| Start Date | 2003-10 |
| Est. Completion | 2009-12 |
| Phase | Phase 3 |
What the finished NCT00071721 record still lists
NCT00071721 is an interventional study that assigns participants to a tested intervention. The registered 313 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (59% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00071721 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00071721's enrollment target sits among peer trials
313 1101st of 2000 higher than 899 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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