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NCT01832350TERMINATEDanonymous

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

Sponsor

Source record

St. Joseph's Hospital and Medical Center, Phoenix

Phase

Source record

PHASE4

Modality

AI-normalized

small molecule

Target

AI-normalized

Nuedexta (20/10)

Indication / condition

AI-normalized

Alzheimer's Disease

Intervention

Source record

Nuedexta (20/10)

Source & freshness

Source record

NCT ID

NCT01832350

Original source

ClinicalTrials.gov

Source last updated

Oct 29, 2019

Ingested at

Jun 08, 2026

Internal sync

Jun 08, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

Open original registry record
View original source fields

NCT ID

NCT01832350

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

Sponsor

St. Joseph's Hospital and Medical Center, Phoenix

Status

TERMINATED

Phase

PHASE4

Condition raw

Alzheimer's Disease, Pseudobulbar Affect (PBA)

Condition normalized

Alzheimer's Disease, Pseudobulbar Affect (PBA)

Modality raw

small molecule

Modality normalized

small molecule

Target raw

Nuedexta (20/10)

Target normalized

Nuedexta (20/10)

Interventions

Nuedexta (20/10)

Public preview

Source record

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).

AI-generated analysis supports research triage only. Verify source records, publications, sponsor disclosures and IP databases before making diligence decisions. Model: trialsignal-ai-v1.

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