Alzheimer's Disease Education and Referral Center

AVP-923 for Treatment of Agitation in Alzheimer's Patients

AVP-923 for Treatment of Agitation in Alzheimer's Patients

Overall Status: 
Completed
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 AgeMax AgeGenderHealthy 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 8-26 (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 four times per week on four 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 CityStateZip CodeStatusPrimary Contact

Geolocation is 33.4636012, -112.0535987

Site
Phoenix
Arizona
85006
Name:
Phone:

Geolocation is 33.612697, -112.280129

Site
Sun City
Arizona
85351
Name:
Phone:

Geolocation is 36.8638688, -119.7715563

Site
Fresno
California
93720
Name:
Phone:

Geolocation is 33.9041552, -117.9307584

Site
Fullerton
California
92835
Name:
Phone:

Geolocation is 34.070264, -118.4440562

Site
Los Angeles
California
90095
Name:
Phone:

Geolocation is 34.0522561, -118.452087

Site
Los Angeles
California
90073
Name:
Phone:

Geolocation is 32.749789, -117.1676501

Site
San Diego
California
92103
Name:
Phone:

Geolocation is 37.7929789, -122.4212424

Site
San Francisco
California
94109
Name:
Phone:

Geolocation is 34.1423899, -118.4571974

Site
Sherman Oaks
California
91403
Name:
Phone:

Geolocation is 33.5273381, -117.1147095

Site
Temecula
California
92591
Name:
Phone:

Geolocation is 26.5386936, -80.0814292

Site
Boynton Beach
Florida
33426
Name:
Phone:

Geolocation is 26.2778269, -80.109357

Site
Deerfield Beach
Florida
33064
Name:
Phone:

Geolocation is 25.8641207, -80.3045967

Site
Hialeah
Florida
33012
Name:
Phone:

Geolocation is 25.8207159, -80.1819268

Site
Miami
Florida
33137
Name:
Phone:

Geolocation is 25.7038331, -80.360297

Site
Miami
Florida
33173
Name:
Phone:

Geolocation is 25.8035656, -80.3185252

Site
Miami
Florida
33122
Name:
Phone:

Geolocation is 29.1571921, -82.1223977

Site
Ocala
Florida
34471
Name:
Phone:

Geolocation is 28.5085825, -81.3564411

Site
Orlando
Florida
32806
Name:
Phone:

Geolocation is 26.17785, -80.2711588

Site
Sunrise
Florida
33351
Name:
Phone:

Geolocation is 27.9407591, -82.5104655

Site
Tampa
Florida
33609
Name:
Phone:

Geolocation is 26.7619563, -80.1037721

Site
West Palm Beach
Florida
33407
Name:
Phone:

Geolocation is 26.7152999, -80.1037721

Site
West Palm Beach
Florida
33409
Name:
Phone:

Geolocation is 26.0621374, -80.3769999

Site
Weston
Florida
33331
Name:
Phone:

Geolocation is 42.0039178, -87.9703461

Site
Elk Grove Village
Illinois
60007
Name:
Phone:

Geolocation is 36.1922841, -115.1592718

Site
Las Vegas
Nevada
89106
Name:
Phone:

Geolocation is 36.1148054, -115.2778317

Site
Las Vegas
Nevada
89147
Name:
Phone:

Geolocation is 40.7161976, -74.359479

Site
Summit
New Jersey
07902
Name:
Phone:

Geolocation is 39.9471038, -74.2531465

Site
Toms River
New Jersey
08757
Name:
Phone:

Geolocation is 41.0464858, -73.9495818

Site
Orangeburg
New York
10962
Name:
Phone:

Geolocation is 43.1301942, -77.6020569

Site
Rochester
New York
14620
Name:
Phone:

Geolocation is 41.0112762, -73.7419017

Site
White Plains
New York
10605
Name:
Phone:

Geolocation is 39.6400784, -84.1751648

Site
Centerville
Ohio
45459
Name:
Phone:

Geolocation is 39.1495912, -84.3909991

Site
Cincinnati
Ohio
45227
Name:
Phone:

Geolocation is 41.5034433, -81.6205953

Site
Cleveland
Ohio
44195
Name:
Phone:

Geolocation is 40.0097883, -83.0683519

Site
Columbus
Ohio
43221
Name:
Phone:

Geolocation is 41.4836446, -81.806039

Site
Lakewood
Ohio
44107
Name:
Phone:

Geolocation is 40.6084305, -75.4901833

Site
Allentown
Pennsylvania
18104
Name:
Phone:

Geolocation is 40.3572766, -75.9085792

Site
Reading
Pennsylvania
19604
Name:
Phone:

Geolocation is 32.7791432, -79.9248669

Site
Charleston
South Carolina
29401
Name:
Phone:

Geolocation is 29.7050857, -95.4018087

Site
Houston
Texas
77030
Name:
Phone:

Geolocation is 29.4687013, -98.6215649

Site
San Antonio
Texas
78238
Name:
Phone:

Geolocation is 40.7078639, -111.8508966

Site
Salt Lake City
Utah
84106
Name:
Phone:

Geolocation is 42.8781345, -73.1967741

Site
Bennington
Vermont
05201
Name:
Phone:

Geolocation is 47.6457534, -117.4253653

Site
Spokane
Washington
99204
Name:
Phone:
Lead Sponsor: 
Agency
Avanir Pharmaceuticals
Collaborator Sponsor: 
Facility Investigators: 
Study Contact: 
NamePhoneEmail
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: 
June 2014
Disease Stage: 
Middle
Enrollment: 
200