Nuedexta in the Treatment of Pseudobulbar Affect in Patients With Alzheimer's Disease
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ClinicalTrials.gov Identifier: NCT01832350 |
Recruitment Status :
Terminated
(Sponsor decided to stop study early)
First Posted : April 16, 2013
Last Update Posted : October 29, 2019
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Condition or disease | Intervention/treatment | Phase |
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Alzheimer's Disease Pseudobulbar Affect (PBA) | Drug: Nuedexta (20/10) | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 34 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Supportive Care |
Official Title: | Clinical Protocol of a Prospective, Open-label Study to Assess the Safety and Efficacy of Nuedexta (Dextromethorphan/Quinidine) in the Treatment of Pseudobulbar Affect (PBA) in Patients With Alzheimer's Disease |
Actual Study Start Date : | August 28, 2012 |
Actual Primary Completion Date : | December 1, 2015 |
Actual Study Completion Date : | December 1, 2016 |

Arm | Intervention/treatment |
---|---|
Experimental: Nuedexta (20/10)
Drug: Nuedexta (20/10) administered orally, two times a day (every 12 hours), during a 26-week period.
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Drug: Nuedexta (20/10)
Drug: Nuedexta (20/10) administered orally, two times a day, every 12 hours, during a 26-week period.
Other Name: Dextromethorphan/Quinidine |
- reduction of PBA frequency [ Time Frame: 1, 13, and 26 weeks after initiation of treatment ]
- reduction of PBA severity [ Time Frame: 1, 13, and 26 weeks after initiation of treatment ]

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Ages Eligible for Study: | 55 Years to 90 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01832350
United States, Arizona | |
Barrow Neurological Institute | |
Phoenix, Arizona, United States, 85013 |
Principal Investigator: | Jiong Shi, MD, PhD | Barrow Neurological Institute, St. Joseph's Hospital and Medical Center, Phoenix AZ |
Responsible Party: | St. Joseph's Hospital and Medical Center, Phoenix |
ClinicalTrials.gov Identifier: | NCT01832350 |
Other Study ID Numbers: |
AVP923 |
First Posted: | April 16, 2013 Key Record Dates |
Last Update Posted: | October 29, 2019 |
Last Verified: | October 2019 |
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders Quinidine Dextromethorphan Antitussive Agents Respiratory System Agents Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Adrenergic alpha-Antagonists Adrenergic Antagonists Adrenergic Agents Anti-Arrhythmia Agents Antimalarials Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Enzyme Inhibitors Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents |