Treatment of Elderly Subjects With Psychosis and Behavioral Disturbances Associated With Dementia of the Alzheimer's Type

Phase 3

Terminated

• Conditions: Psychosis and Behavioral Disturbances Associated With Dementia of the Alzheimer's Type
• Interventions: Drug: Placebo; Drug: bifeprunox

• Registration Number: NCT00160147
• Lead Sponsor: Solvay Pharmaceuticals

Brief Summary

This is a 10-week study with bifeprunox and placebo in elderly subjects with psychosis and behavioral disturbances associated with dementia of the alzheimer's type.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-08
• Study First Posted: 2005-09-12
• Study Start: 2005-12
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Status Verified: 2009-06
• Disposition First Submitted: 2015-01-29
• Disposition First Submitted QC: 2015-01-29
• Last Update Submitted: 2015-01-29
• Disposition First Posted: 2015-02-09
• Last Update Posted: 2015-02-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Diagnosis of dementia of the Alzheimer's type

Exclusion Criteria

• History of seizure disorder
• Clinically significant electrocardiogram (ECG)
• Clinical or radiological evidence of stroke, vascular dementia or dementia due to substance abuse, or head trauma

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	-
1	bifeprunox	-

Primary Outcome Measures

Name	Time	Method
Brief Psychiatric Rating Scale (BPRS) Total Score	10 weeks

Secondary Outcome Measures

Name	Time	Method
Adverse events	10 weeks

Trial Locations

Locations (51)

Site 910; 🇺🇸 Santa Ana, California, United States

Site 902; 🇺🇸 Carson, California, United States

Site 911; 🇺🇸 Pasadena, California, United States

Site 922; 🇺🇸 San Marino, California, United States

Site 901; 🇺🇸 Miami, Florida, United States

Site 931; 🇺🇸 Norwalk, Connecticut, United States

Site 907; 🇺🇸 North Miami, Florida, United States

Site 933; 🇺🇸 Orange City, Florida, United States

Site 934; 🇺🇸 Atlanta, Georgia, United States

Site 917; 🇺🇸 Blue Ridge, Georgia, United States

Site 925; 🇺🇸 Newnan, Georgia, United States

Site 919; 🇺🇸 Bedford, Massachusetts, United States

Site 940; 🇺🇸 St. Louis, Missouri, United States

Site 923; 🇺🇸 Boston, Massachusetts, United States

Site 930; 🇺🇸 St. Louis, Missouri, United States

Site 941; 🇺🇸 Olean, New York, United States

Site 921; 🇺🇸 Staten Island, New York, United States

Site 927; 🇺🇸 St. Louis, Missouri, United States

Site 909; 🇺🇸 Cincinnati, Ohio, United States

Site 908; 🇺🇸 Oklahoma City, Oklahoma, United States

Site 916; 🇺🇸 Oklahoma City, Oklahoma, United States

Site 935; 🇺🇸 Philadelphia, Pennsylvania, United States

Site 936; 🇺🇸 Austin, Texas, United States

Site 913; 🇺🇸 Williamsburg, Virginia, United States

Site 928; 🇺🇸 Dallas, Texas, United States

Site 918; 🇺🇸 Waukesha, Wisconsin, United States

Site 803; 🇨🇿 Litomerice, Czech Republic

Site 808; 🇮🇱 Beer Yaakov, Israel

Site 816; 🇮🇱 Pardes Hana, Israel

Site 813; 🇵🇱 Gdansk, Poland

Site 903; 🇺🇸 Long Beach, California, United States

Site 810; 🇮🇱 Rehovot, Israel

Site 814; 🇵🇱 Choroszcz, Poland

Site 815; 🇵🇱 Torun, Poland

Site 906; 🇺🇸 Shreveport, Louisiana, United States

Site 812; 🇮🇱 Bat Yam, Israel

Site 805; 🇨🇿 Skvorec, Czech Republic

Site 912; 🇺🇸 Phoenix, Arizona, United States

Site 905; 🇺🇸 Shreveport, Louisiana, United States

Site 801; 🇨🇿 Tabor, Czech Republic

Site 932; 🇺🇸 Humboldt, Tennessee, United States

Site 807; 🇪🇪 Viljandimaa, Estonia

Site 811; 🇮🇱 Hadera, Israel

Site 809; 🇮🇱 Tirat HaCarmel, Israel

Site 929; 🇺🇸 Hamden, Connecticut, United States

Site 802; 🇨🇿 Lnare, Czech Republic

Site 804; 🇨🇿 Praha, Czech Republic

Site 806; 🇪🇪 Voru Maakond, Estonia

Site 914; 🇺🇸 New Britain, Connecticut, United States

Site 904; 🇺🇸 New Orleans, Louisiana, United States

Site 942; 🇺🇸 Flowood, Mississippi, United States