Efficacy, Safety and Tolerability Study of AVP-923 (Dextromethorphan/Quinidine) for Treatment of Symptoms of Agitation in Participants With Alzheimer's Disease
NCT ID: NCT01584440
Last Updated: 2021-11-26
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
220 participants
INTERVENTIONAL
2012-08-13
2014-07-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
This is a multicenter, randomized, double-dummy, double-blind, placebo-controlled study, consisting of 10 weeks of treatment.
Up to 200 participants will be enrolled at approximately 30-40 centers in the US.
Study medication will be administered orally twice-daily from Day 1 through Day 70. Screening must occur within within approximately 4 weeks prior to randomization. Following screening procedures for assessment of inclusion and exclusion criteria, eligible participants will be randomized into the study.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo
Participants will receive placebo during Stage 1 and Stage 2 of the study.
Placebo
Placebo capsule
AVP-923
Participants will receive AVP-923-20 and AVP-923-30 in a sequential manner during Stage 1 and Stage 2 of the study.
AVP-923-20
AVP-923-20: 20 mg of dextromethorphan and 10 mg of quinidine
AVP-923-30
AVP-923-30: 30 mg of dextromethorphan and 10 mg of quinidine
Placebo then AVP-923
Participants will receive placebo in Stage 1 followed by AVP-923 in Stage 2.
AVP-923-20
AVP-923-20: 20 mg of dextromethorphan and 10 mg of quinidine
Placebo
Placebo capsule
AVP-923-30
AVP-923-30: 30 mg of dextromethorphan and 10 mg of quinidine
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
AVP-923-20
AVP-923-20: 20 mg of dextromethorphan and 10 mg of quinidine
Placebo
Placebo capsule
AVP-923-30
AVP-923-30: 30 mg of dextromethorphan and 10 mg of quinidine
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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.
Exclusion Criteria
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.
50 Years
90 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Avanir Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Phoenix, Arizona, United States
Sun City, Arizona, United States
Fresno, California, United States
Fullerton, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
San Diego, California, United States
San Francisco, California, United States
Sherman Oaks, California, United States
Temecula, California, United States
Boynton Beach, Florida, United States
Deerfield Beach, Florida, United States
Hialeah, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Ocala, Florida, United States
Orlando, Florida, United States
Sunrise, Florida, United States
Tampa, Florida, United States
West Palm Beach, Florida, United States
West Palm Beach, Florida, United States
Weston, Florida, United States
Elk Grove Village, Illinois, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Summit, New Jersey, United States
Toms River, New Jersey, United States
Orangeburg, New York, United States
Rochester, New York, United States
White Plains, New York, United States
Centerville, Ohio, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Lakewood, Ohio, United States
Allentown, Pennsylvania, United States
Reading, Pennsylvania, United States
Charleston, South Carolina, United States
Houston, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Bennington, Vermont, United States
Spokane, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
12-AVR-131
Identifier Type: -
Identifier Source: org_study_id