Efficacy, Safety and Tolerability Study of AVP-923 (Dextromethorphan/Quinidine) for Treatment of Symptoms of Agitation in Participants With Alzheimer's Disease
A Phase 2, Randomized, Double-dummy, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety and Tolerability of AVP-923 (Dextromethorphan/Quinidine) for the Treatment of Symptoms of Agitation in Patients With Alzheimer's Disease.
1 other identifier
interventional
220
1 country
44
Brief Summary
The objectives of the study are to evaluate the safety, tolerability and efficacy of AVP-923 compared to placebo, for the treatment of symptoms of agitation in participants with Alzheimer's Disease (AD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2012
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 23, 2012
CompletedFirst Posted
Study publicly available on registry
April 25, 2012
CompletedStudy Start
First participant enrolled
August 13, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2014
CompletedResults Posted
Study results publicly available
November 26, 2021
CompletedNovember 26, 2021
October 1, 2021
2 years
April 23, 2012
October 29, 2021
October 29, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in the Neuropsychiatric Inventory (NPI) Agitation/Aggression Domain Score From Day 1 (Stage 1 Baseline) to Day 36 (Stage 2 Baseline) and From Day 36 to Day 70
The NPI is a retrospective interview covering 12 neuropsychiatric symptom domains and is used to evaluate psychopathology, neuropsychiatric manifestations, and caregiver distress. The Agitation/Aggression domain was designed to collect information on the behavioral aspects of agitation/aggression in participants with probable Alzheimer's Disease (AD) and clinically meaningful agitation secondary to AD. Each NPI domain is rated by the caregiver for symptom frequency and severity. Symptom frequency is rated as: 1, occasionally; 2, often; 3, frequently; 4, very frequently. Symptom severity is rated as: 1, mild; 2, moderate; 3, marked. The total domain score is calculated as the frequency score multiplied by the severity score and thus ranges from 1 to 12. A higher score represents worsening symptoms. Change from Baseline is calculated as the post-Baseline score minus the Baseline score. Data are reported for only those participants contributing data to the analysis.
Day 1 (Stage 1 Baseline); Day 36 (Stage 2 Baseline); Day 70
Secondary Outcomes (21)
Number of Participants With the Indicated Type of Adverse Event
up to Week 10
Change in the Total NPI Score From Day 1 (Stage 1 Baseline) to Day 36 (Stage 2 Baseline) and From Day 36 to Day 70
Day 1 (Stage 1 Baseline); Day 36 (Stage 2 Baseline); Day 70
Change in the Individual NPI Domain Scores From Day 1 (Stage 1 Baseline) to Day 36 (Stage 2 Baseline) and From Day 36 to Day 70
Day 1 (Stage 1 Baseline); Day 36 (Stage 2 Baseline); Day 70
Change in the Sum of the Agitation/Aggression, Irritability/Lability, Disinhibition, and Aberrant Motor Behavior NPI Domain (NPI4D) Score From Day 1 (Stage 1 Baseline) to Day 36 (Stage 2 Baseline) and From Day 36 to Day 70
Day 1 (Stage 1 Baseline); Day 36 (Stage 2 Baseline); Day 70
Change in the Sum of the Agitation/Aggression, Irritability/Lability, Anxiety, and Aberrant Motor Behavior NPI Domain (NPI4A) Score From Day 1 (Stage 1 Baseline) to Day 36 (Stage 2 Baseline) and From Day 36 to Day 70
Day 1 (Stage 1 Baseline); Day 36 (Stage 2 Baseline); Day 70
- +16 more secondary outcomes
Study Arms (3)
Placebo
PLACEBO COMPARATORParticipants will receive placebo during Stage 1 and Stage 2 of the study.
AVP-923
EXPERIMENTALParticipants will receive AVP-923-20 and AVP-923-30 in a sequential manner during Stage 1 and Stage 2 of the study.
Placebo then AVP-923
EXPERIMENTALParticipants will receive placebo in Stage 1 followed by AVP-923 in Stage 2.
Interventions
AVP-923-20: 20 mg of dextromethorphan and 10 mg of quinidine
AVP-923-30: 30 mg of dextromethorphan and 10 mg of quinidine
Eligibility Criteria
You may qualify if:
- Diagnosis of probable Alzheimer's disease (AD).
- The participant has clinically significant symptoms of agitation secondary to AD, that interfere with daily routine and for which a prescription medication is deemed indicated, in the opinion of the investigator.
- Either out-patients or residents of an assisted-living facility or a skilled nursing home.
- CGI-S score is ≥ 4 (moderately ill) at screening and baseline.
- Mini Mental State Examination (MMSE) score at screening between 8 and 28 (inclusive).
- Caregiver who is able and willing to comply with all required study procedures, ensuring that the participant attends all study visits and takes the study medication as instructed. In order to qualify as a caregiver for this study, the individual should spend time with the participant for a minimum of 4 hours on 4 separate days per week.
You may not qualify if:
- Participant has other type of dementia (e.g., vascular dementia, frontotemporal dementia, Parkinson's disease, substance-induced dementia).
- Participant with co-existent clinically significant or unstable systemic diseases that could confound the interpretation of the safety results of the study (e.g. malignancy, poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, certain cardiac conduction abnormalities including QTc prolongation, or unstable valvular heart disease).
- Participant with myasthenia gravis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (44)
Unknown Facility
Phoenix, Arizona, 85006, United States
Unknown Facility
Sun City, Arizona, 85351, United States
Unknown Facility
Fresno, California, 93720, United States
Unknown Facility
Fullerton, California, 92835, United States
Unknown Facility
Los Angeles, California, 90073, United States
Unknown Facility
Los Angeles, California, 90095, United States
Unknown Facility
San Diego, California, 92103, United States
Unknown Facility
San Francisco, California, 94109, United States
Unknown Facility
Sherman Oaks, California, 91403, United States
Unknown Facility
Temecula, California, 92591, United States
Unknown Facility
Boynton Beach, Florida, 33426, United States
Unknown Facility
Deerfield Beach, Florida, 33064, United States
Unknown Facility
Hialeah, Florida, 33012, United States
Unknown Facility
Miami, Florida, 33122, United States
Unknown Facility
Miami, Florida, 33137, United States
Unknown Facility
Miami, Florida, 33173, United States
Unknown Facility
Ocala, Florida, 34471, United States
Unknown Facility
Orlando, Florida, 32806, United States
Unknown Facility
Sunrise, Florida, 33351, United States
Unknown Facility
Tampa, Florida, 33609, United States
Unknown Facility
West Palm Beach, Florida, 33407, United States
Unknown Facility
West Palm Beach, Florida, 33409, United States
Unknown Facility
Weston, Florida, 33331, United States
Unknown Facility
Elk Grove Village, Illinois, 60007, United States
Unknown Facility
Las Vegas, Nevada, 89106, United States
Unknown Facility
Las Vegas, Nevada, 89147, United States
Unknown Facility
Summit, New Jersey, 07902, United States
Unknown Facility
Toms River, New Jersey, 08757, United States
Unknown Facility
Orangeburg, New York, 10962, United States
Unknown Facility
Rochester, New York, 14620, United States
Unknown Facility
White Plains, New York, 10605, United States
Unknown Facility
Centerville, Ohio, 45459, United States
Unknown Facility
Cincinnati, Ohio, 45227, United States
Unknown Facility
Cleveland, Ohio, 44195, United States
Unknown Facility
Columbus, Ohio, 43221, United States
Unknown Facility
Lakewood, Ohio, 44107, United States
Unknown Facility
Allentown, Pennsylvania, 18104, United States
Unknown Facility
Reading, Pennsylvania, 19604, United States
Unknown Facility
Charleston, South Carolina, 29401, United States
Unknown Facility
Houston, Texas, 77030, United States
Unknown Facility
San Antonio, Texas, 78238, United States
Unknown Facility
Salt Lake City, Utah, 84106, United States
Unknown Facility
Bennington, Vermont, 05201, United States
Unknown Facility
Spokane, Washington, 99204, United States
Related Publications (1)
Cummings JL, Lyketsos CG, Peskind ER, Porsteinsson AP, Mintzer JE, Scharre DW, De La Gandara JE, Agronin M, Davis CS, Nguyen U, Shin P, Tariot PN, Siffert J. Effect of Dextromethorphan-Quinidine on Agitation in Patients With Alzheimer Disease Dementia: A Randomized Clinical Trial. JAMA. 2015 Sep 22-29;314(12):1242-54. doi: 10.1001/jama.2015.10214.
PMID: 26393847BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Avanir Medical Information
- Organization
- Avanir Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2012
First Posted
April 25, 2012
Study Start
August 13, 2012
Primary Completion
July 30, 2014
Study Completion
July 30, 2014
Last Updated
November 26, 2021
Results First Posted
November 26, 2021
Record last verified: 2021-10