AVP-923 for Treatment of Agitation in Alzheimer's Patients
AVP-923 for Treatment of Agitation in Alzheimer's Patients
Overall Status:
Recruiting
Brief Description:
The purpose of this Phase II study is to evaluate the safety, tolerability, and efficacy of AVP-923, compared to a placebo, for the treatment of agitation in people with Alzheimer's disease.
Patient Qualifications:
| Min Age | Max Age | Gender | Healthy Volunteers |
|---|---|---|---|
50 Years | 90 Years | Both | No |
Inclusion Criteria:
- Diagnosis of probable Alzheimer's disease
- Significant symptoms of agitation secondary to Alzheimer's that interfere with daily routine and for which a prescription medication is indicated
- Either outpatient or resident of an assisted living facility or skilled nursing home
- CGI-S score of ≥4 (moderately ill) at screening and baseline
- Mini Mental State Examination score of 8-24 (inclusive) at screening
- Caregiver who can ensure that the participant attends all study visits and takes the study medication as instructed; caregiver must spend a minimum of three times per week on three separate days with the person with Alzheimer's
Exclusion Criteria:
- Other type of dementia (e.g., vascular dementia, frontotemporal dementia, Parkinson's disease, substance-induced dementia)
- Clinically significant or unstable systemic diseases that could confound the interpretation of the study's safety results (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, such as QTc prolongation or unstable valvular heart disease)
- Myasthenia gravis
Detailed Description:
In this study, participants will be randomly assigned to receive either the study medication AVP-923, administered orally twice, or a placebo. Treatment will last for 10 weeks. AVP-923 contains dextromethorphan, an antitussive cough medicine, and quinidine, a drug used to treat abnormal heart rhythms.
Central Contact Information:
For more information about this study, contact Paul Shin at 949-268-5930 or PShin@avanir.com or Joao Siffert, MD, at 949-268-1174 or JSiffert@avanir.com.
Locations:
| Map Marker | City | State | Zip Code | Status | |
|---|---|---|---|---|---|
Geolocation is 33.4636012, -112.0535987 | Site | Phoenix | Arizona | 85006 | Recruiting |
Geolocation is 33.612697, -112.280129 | Site | Sun City | Arizona | 85351 | Recruiting |
Geolocation is 36.8638688, -119.7715563 | Site | Fresno | California | 93720 | Recruiting |
Geolocation is 34.070264, -118.4440562 | Site | Los Angeles | California | 90095 | Recruiting |
Geolocation is 32.749789, -117.1676501 | Site | San Diego | California | 92103 | Recruiting |
Geolocation is 37.7929789, -122.4212424 | Site | San Francisco | California | 94109 | Recruiting |
Geolocation is 34.1423899, -118.4571974 | Site | Sherman Oaks | California | 91403 | Recruiting |
Geolocation is 26.2778269, -80.109357 | Site | Deerfield Beach | Florida | 33064 | Recruiting |
Geolocation is 25.8207159, -80.1819268 | Site | Miami | Florida | 33137 | Recruiting |
Geolocation is 26.17785, -80.2711588 | Site | Sunrise | Florida | 33351 | Recruiting |
Geolocation is 28.0869646, -82.4698603 | Site | Tampa | Florida | 33613 | Recruiting |
Geolocation is 26.7619563, -80.1037721 | Site | West Palm Beach | Florida | 33407 | Recruiting |
Geolocation is 26.7152999, -80.1037721 | Site | West Palm Beach | Florida | 33409 | Recruiting |
Geolocation is 26.0621374, -80.3769999 | Site | Weston | Florida | 33331 | Recruiting |
Geolocation is 42.0113617, -88.0020589 | Site | Elk Grove Village | Illinois | 60007 | Recruiting |
Geolocation is 36.1922841, -115.1592718 | Site | Las Vegas | Nevada | 89106 | Recruiting |
Geolocation is 40.7161976, -74.359479 | Site | Summit | New Jersey | 07902 | Recruiting |
Geolocation is 39.9471038, -74.2531465 | Site | Toms River | New Jersey | 08757 | Recruiting |
Geolocation is 41.0481178, -73.9301037 | Site | Orangeburg | New York | 10962 | Recruiting |
Geolocation is 43.1301942, -77.6020569 | Site | Rochester | New York | 14620 | Recruiting |
Geolocation is 39.6400784, -84.1751648 | Site | Centerville | Ohio | 45459 | Recruiting |
Geolocation is 41.5034433, -81.6205953 | Site | Cleveland | Ohio | 44195 | Recruiting |
Geolocation is 40.0097883, -83.0683519 | Site | Columbus | Ohio | 43221 | Recruiting |
Geolocation is 41.4836446, -81.806039 | Site | Lakewood | Ohio | 44107 | Recruiting |
Geolocation is 32.9221152, -80.0367259 | Site | North Charleston | South Carolina | 29406 | Recruiting |
Geolocation is 29.7050857, -95.4018087 | Site | Houston | Texas | 77030 | Recruiting |
Geolocation is 29.4687013, -98.6215649 | Site | San Antonio | Texas | 78238 | Recruiting |
Geolocation is 40.7078639, -111.8508966 | Site | Salt Lake City | Utah | 84106 | Recruiting |
Geolocation is 42.8918357, -73.111356 | Site | Bennington | Vermont | 05201 | Recruiting |
Lead Sponsor:
| Agency |
|---|
Avanir Pharmaceuticals |
Collaborator Sponsor:
Facility Investigators:
Study Contact:
| Name | Phone | |
|---|---|---|
Paul Shin | 949-268-5930 | |
Joao Siffert, MD | 949-268-1174 |
Locations
ClinicalTrials.gov ID
NCT01584440 (follow link to view full record on ct.gov in new window)
Official Title:
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
Study Start Date:
June 2012
Study End Date:
March 2014
Disease Stage:
Middle
Enrollment:
200
