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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 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01832350
The ClinicalTrials.gov registry entry for NCT01832350 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is St. Joseph's Hospital and Medical Center, Phoenix, which has 44 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Nuedexta (20/10) is the first listed.
NCT01832350 reports 0 study locations.
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.
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