Status:
TERMINATED
Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type
Lead Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Conditions:
Agitation in Patients With Dementia of the Alzheimer's Type
Eligibility:
All Genders
50-90 years
Phase:
PHASE3
Brief Summary
This study was conducted to evaluate the efficacy, safety, and tolerability of AVP-786 (deudextromethorphan hydrobromide \[d6-DM\]/quinidine sulfate \[Q\]) compared to placebo for the treatment of agi...
Detailed Description
Eligible participants for this study had a diagnosis of probable Alzheimer's disease (AD) and had clinically significant, moderate/severe agitation secondary to AD. This was multicenter, randomized, ...
Eligibility Criteria
Inclusion
- Participants with a diagnosis of probable Alzheimer's disease according to the 2011 Neuropsychiatric Inventory Agitation/Aggression (NPI-AA) working groups criteria
- Participants with clinically significant, moderate-to-severe agitation for at least 2 weeks prior to Screening that interferes with daily routine per the Investigator's judgment
- Participants who require pharmacotherapy for the treatment of agitation per the Investigator's judgment after an evaluation of reversible factors and a course of nonpharmacological interventions
- Diagnosis of agitation must meet the International Psychogeriatric Association (IPA) provisional definition of agitation.
- Participants meeting an additional predetermined blinded eligibility criterion, which will remain blinded to the clinical study site Investigators and staff
- Participants with a reliable caregiver who is able and willing to comply with all study procedures, including adherence to administering study drug and not administering any prohibited medications during the course of the study, and who spends a minimum of 2 hours per day for 4 days per week with the participant
Exclusion
- Participants with dementia predominantly of the non-Alzheimer's type (e.g., vascular dementia, frontotemporal dementia, Parkinson's disease, substance-induced dementia)
- Participants with symptoms of agitation that are not secondary to Alzheimer's dementia (e.g., secondary to pain, other psychiatric disorder, or delirium)
- Participants with co-existent clinically significant or unstable systemic diseases that could confound the interpretation of the safety results of the study (e.g., malignancy \[except skin basal-cell carcinoma\], poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, or unstable valvular heart disease)
- Participants with myasthenia gravis
Key Trial Info
Start Date :
September 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 28 2024
Estimated Enrollment :
241 Patients enrolled
Trial Details
Trial ID
NCT04464564
Start Date
September 11 2020
End Date
June 28 2024
Last Update
May 30 2025
Active Locations (106)
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1
Clinical Research Site #840-020
Phoenix, Arizona, United States, 85004
2
Clinical Research Site #840-047
Anaheim, California, United States, 92805
3
Clinical Research Site #840-090
Costa Mesa, California, United States, 92626
4
Clinical Research Site #840-059
Lafayette, California, United States, 94549