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NCT01832350 · ClinicalTrials.gov registry record · Phase 4
Nuedexta in the Treatment of Pseudobulbar Affect in Patients With Alzheimer's Disease
A Phase 4 study, sponsored by St. Joseph's Hospital and Medical Center, Phoenix.
- Terminated
- Registry status
- Phase 4
- Development phase
- 34
- Enrollment target
NCT01832350: Clinical Trial Phase 4 study, sponsored by St. Joseph's Hospital and Medical Center, Phoenix.
NCT01832350 is a Phase 4 study that was terminated before completion, run by St. Joseph's Hospital and Medical Center, Phoenix. The registered enrollment target is 34 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01832350, a Phase 4 study, was terminated before completion, sponsored by St. Joseph's Hospital and Medical Center, Phoenix.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 34 participants
- Enrollment target
Study Summary
The primary objective of this study is to test the hypothesis that Nuedexta (20/10) administered orally will reduce Pseudobulbar Affect (PBA) frequency and severity (CNS-Lability Scale and PLACS), with satisfactory safety and high tolerability in patients with Alzheimer's Disease (AD). The primary objective will be evaluated using a study endpoint at 1, 13, 26 weeks after initiation of treatment. The secondary objective of this study is to evaluate the benefit of treatment with Nuedexta (20/10) on cognition and functionality as demonstrated in the Rey Auditory Verbal Learning Test (RAVLT), Trail making A and B, Wechsler Memory Scale (WMS) logical memory and delayed recall, Controlled Oral Word Association (COWA), Clinical Dementia Rating (CDR), Neuropsychiatric Inventory (NPI), Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCSADL) and the 11-item Alzheimer's Disease Assessment Scale-Cognitive subscore (ADAS-Cog11).
Interventions
- DRUG Nuedexta (20/10)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2012-08-28 |
| Est. Completion | 2016-12-01 |
| Phase | Phase 4 |
Why NCT01832350 stopped before completion
NCT01832350 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 1 intervention - of which Nuedexta (20/10) is the first listed.
NCT01832350 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01832350 about?
NCT01832350 is a clinical study titled "Nuedexta in the Treatment of Pseudobulbar Affect in Patients With Alzheimer's Disease". The primary objective of this study is to test the hypothesis that Nuedexta (20/10) administered orally will reduce Pseudobulbar Affect (PBA) frequency and severity (CNS-Lability Scale and PLACS), with satisfactory safety and high tolerability in patients with Alzheimer's Disease (AD). The primary o...
What is the current status of trial NCT01832350?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 34 participants. The study started on 2012-08-28. Estimated completion is 2016-12-01.
What interventions are being tested in trial NCT01832350?
The interventions under investigation include: Nuedexta (20/10) (DRUG).
Who is sponsoring clinical trial NCT01832350?
This trial is sponsored by St. Joseph's Hospital and Medical Center, Phoenix, which has 44 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01832350's enrollment target sits among peer trials
34 1520th of 2000 higher than 473 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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