Alzheimer's Disease Education and Referral Center

Nuedexta for Treating Pseudobulbar Affect in Alzheimer's Disease

Overall Status:

Recruiting

Brief Description:

Nuedexta (dextromethorphan/quinidine) is an approved treatment for pseudobulbar affect (PBA), a neurological disorder characterized by sudden, unpredictable episodes of crying and/or laughing. These episodes are uncontrolled, exaggerated, or different from a person's true feelings. PBA occurs in people with neurological diseases and conditions such as Alzheimer's, brain injury, or stroke. In this trial, investigators will test Nuedexta in people with Alzheimer's disease to see if if can reduce the number and severity of PBA episodes.

Patient Qualifications:

Min Age	Max Age	Gender	Healthy Volunteers
55 Years	90 Years	Both	No

Inclusion Criteria:

Probable Alzheimer's disease, as defined by criteria of the National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association
Modified Hachinski Ischemia Scale score of ≤4; Mini Mental State Examination score of 16-26; Geriatric Depression Scale score of ≤6
Clinical history and symptoms of pseudobulbar affect
No current symptoms of depressive disorder; participants with history of depression may have been on steady dose of antidepressant for at least 3 months and remain on stable dose throughout the study
Stable hematologic, hepatic, and renal function, with no clinically significant symptoms and with laboratory results up to one-fold higher than upper limit of normal range
Resting respiratory rate of 12-20 per minute
MRI or CT scan findings consistent with a diagnosis of Alzheimer's within the past 12 months
Electrocardiogram within 4 weeks prior to entry, with no evidence of clinically significant abnormalities
If taking acetylcholinesterase inhibitor or memantine, must have been on stable dose for at least 2 months before screening
Reliable caregiver in frequent contact with patient (at least 10 hours per week)

Exclusion Criteria:

Current serious or unstable illnesses that, in the investigator's opinion, could interfere with analysis of safety and efficacy data; life expectancy of less than 2 years
Current or prior history of major psychiatric disturbance; history of chronic alcohol or drug abuse/dependence within the past 5 years; at serious risk of suicide
Participation in another clinical study within the past 30 days
Multiple episodes of head trauma; history within the past year of serious infectious disease affecting the brain, head trauma resulting in protracted loss of consciousness, or myasthenia gravis
History within the past 5 years of malignant disease
Known sensitivity to quinidine or dextromethorphan or received Nuedexta within the past 6 months
History of human immunodeficiency virus, multiple or severe drug allergies, or severe post-treatment hypersensitivity reactions
Recent or current lab result indicating clinically significant lab abnormality
Hypotension (systolic blood pressure of <100 mm Hg); postural or unexplained fainting
Use of medications for less than 4 weeks that affect the central nervous system (except for Alzheimer's medications)
Acute exacerbation of underlying neurological disorder within the past 2 months

Detailed Description:

Nuedexta (dextromethorphan/quinidine) is an approved treatment for pseudobulbar affect (PBA), a neurological disorder characterized by sudden, unpredictable episodes of crying and/or laughing. These episodes are uncontrolled, exaggerated, or different from a person's true feelings. PBA occurs in people with neurological diseases and conditions such as Alzheimer's, brain injury, or stroke. In this Phase IV trial, participants with mild to moderate Alzheimers disease and pseudobulbar affect will take the approved drug Neudexta to see if it can alleviate PBA. The objective is to evaluate the benefit of treatment on PBA as well as on cognition and functionality, as demonstrated by performance on several neuropsychological tests.

Locations:

Map Marker		City	State	Zip Code	Status	Primary Contact
Geolocation is 33.5080943, -112.0863874	Barrow Neurological Institute	Phoenix	Arizona	85013	Recruiting	Catherine Young 602-406-3719 catherine.young@dignityhealth.org

Agency
St. Joseph's Hospital and Medical Center

Agency
Avanir Pharmaceuticals

Facility Investigators:

Name	Role	Affiliation
Jiong Shi, MD, PhD	Principal Investigator	Barrow Neurological Institute, St. Joseph's Hospital and Medical Center

Study Contact:

Name	Phone	Email
Catherine Young	602-406-3719	catherine.young@dignityhealth.org

Locations

ClinicalTrials.gov ID

NCT01832350 (follow link to view full record on ct.gov in new window)

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

Study Start Date:

December 2012

Study End Date:

June 2015

Disease Stage:

Early

Middle

Enrollment:

Trial References:

Schiffer R, Pope LE. Review of pseudobulbar affect including a novel and potential therapy. J Neuropsychiatry Clin Neurosci. 2005 Fall;17(4):447-54. Review.

Green RL. Regulation of Affect. Semin Clin Neuropsychiatry. 1998 Jul;3(3):195-200.

Lieberman A, Benson DF. Control of emotional expression in pseudobulbar palsy. A personal experience. Arch Neurol. 1977 Nov;34(11):717-9.