TerminatedPhase 4

Nuedexta in the Treatment of Pseudobulbar Affect in Patients With Alzheimer's Disease

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

Lead sponsor

St. Joseph's Hospital and Medical Center, Phoenix

Asset

Nuedexta

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•AD symptomatic therapy: stable ≥2 months

Primary endpoint

•PBA frequency

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDAVP923

NCT IDNCT01832350

Timeline

Milestones

Study start2012-08-28actual

Study first posted2013-04-16estimated

Primary completion2015-12-01actual

Study completion2016-12-01actual

Last update posted2019-10-29actual

Assets

Drug assets

Nuedexta

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years

Maximum age90 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Other (unclassified)

2 endpoints

Primary/protocol endpoint/low confidence

reduction of PBA frequency

Time frame:1, 13, and 26 weeks after initiation of treatment

event count, event

Secondary/protocol endpoint/low confidence

reduction of PBA severity

Time frame:1, 13, and 26 weeks after initiation of treatment

descriptive

Publications (8)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.