Status:
TERMINATED
Nuedexta in the Treatment of Pseudobulbar Affect in Patients With Alzheimer's Disease
Lead Sponsor:
St. Joseph's Hospital and Medical Center, Phoenix
Collaborating Sponsors:
Avanir Pharmaceuticals
Conditions:
Alzheimer's Disease
Pseudobulbar Affect (PBA)
Eligibility:
All Genders
55-90 years
Phase:
PHASE4
Brief 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), wit...
Eligibility Criteria
Inclusion
- Male/female 55 to 90 years, inclusive.
- Meets National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association criteria for probable AD.
- Modified Hachinski Ischemia Scale score of ≤4.
- Folstein Mini Mental State Exam score 16-26 at Visit 1.
- Geriatric Depression Scale score ≤6. For patient with history of depression, he/she have been on steady dose of anti-depressant for at least 3 months.
- Clinical history and relevant symptoms of Pseudobulbar Affect.
- Center for Neurologic Study-Lability Scale score at baseline ≥13.
- Stable hematologic, hepatic, and renal function, with no clinically significant symptoms, and with clinical laboratory results (CBC, clinical chemistry, and urinalysis) up to 1-fold higher than upper limit of normal range.
- Resting respiratory rate 12-20/minute.
- MRI or CT scan within past 12 months; no findings inconsistent with diagnosis of AD.
- ECG (within 4 weeks prior to entry)with no evidence of clinically significant abnormalities.
- Concurrent treatment with an acetylcholinesterase inhibitor or memantine allowed; must be on stable dose at least 2 months before screening. Dosing must remain stable throughout the study.
- Use of SSRI's allowed. Must have used for 3 months prior to study entry; dose must remain unchanged during course of study.
- No current symptoms of depressive disorder.
- Score of 19 or lower in the Beck Depression Inventory.
- Agrees to use no prohibited medications during study.
Exclusion
- Has current serious or unstable illnesses that, in investigator's opinion, could interfere with analysis of safety and efficacy data; has life expectancy \<2 years.
- No reliable caregiver in frequent contact with patient (at least 10 hours/week.
- Current or prior history of major psychiatric disturbance.
- Have been in other clinical study within 30 days of entry.
- Score of 20 or higher in Beck Depression Inventory.
- Multiple episodes of head trauma, history within last year of serious infectious disease affecting the brain, head trauma resulting in protracted loss of consciousness, or myasthenia gravis.
- Within the last 5 years, history of a primary or recurrent malignant disease.
- Known sensitivity to quinidine or dextromethorphan.
- History of human immunodeficiency virus, multiple or severe drug allergies, or severe post-treatment hypersensitivity reactions.
- History of chronic alcohol or drug abuse/dependence within the past 5 years.
- Judged by investigator to be at serious risk for suicide.
- Has a recent or current lab result indicating clinically significant lab abnormality.
- At Visit 1 has ALT/SGPT values ≥2 times upper limit of normal (ULN); AST/SGOT values ≥3 times the ULN; total bilirubin values ≥2 times the ULN.
- Resting diurnal oxygen saturation \<95%.
- Received dextromethorphan and quinidine within previous 6 months.
- Hypotension (systolic BP \<100 mm Hg); postural syncope; unexplained syncope.
- Used medications that affect the CNS (except for AD) for less than 4 weeks.
- On disallowed concomitant medications.
- Experiencing acute exacerbation of underlying neurological disorder within previous 2 months.
Key Trial Info
Start Date :
August 28 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT01832350
Start Date
August 28 2012
End Date
December 1 2016
Last Update
October 29 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Barrow Neurological Institute
Phoenix, Arizona, United States, 85013