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

January 29, 2015 updated by: Solvay Pharmaceuticals

A Randomized, Double-Blind, Placebo-controlled, Efficacy, Safety, and Tolerability Study of Bifeprunox in the Treatment of Elderly Subjects With Psychosis and Behavioral Disturbances Associated With Dementia of the Alzheimer's Type

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Litomerice, Czech Republic
        • Site 803
      • Lnare, Czech Republic
        • Site 802
      • Praha, Czech Republic
        • Site 804
      • Skvorec, Czech Republic
        • Site 805
      • Tabor, Czech Republic
        • Site 801
  • Estonia
      • Viljandimaa, Estonia
        • Site 807
      • Voru Maakond, Estonia
        • Site 806
  • Israel
      • Bat Yam, Israel
        • Site 812
      • Beer Yaakov, Israel
        • Site 808
      • Hadera, Israel
        • Site 811
      • Pardes Hana, Israel
        • Site 816
      • Rehovot, Israel
        • Site 810
      • Tirat HaCarmel, Israel
        • Site 809
  • Poland
      • Choroszcz, Poland
        • Site 814
      • Gdansk, Poland
        • Site 813
      • Torun, Poland
        • Site 815
  • United States
    • Arizona
      • Phoenix, Arizona, United States
        • Site 912
    • California
      • Carson, California, United States
        • Site 902
      • Long Beach, California, United States
        • Site 903
      • Pasadena, California, United States
        • Site 911
      • San Marino, California, United States
        • Site 922
      • Santa Ana, California, United States
        • Site 910
    • Connecticut
      • Hamden, Connecticut, United States
        • Site 929
      • New Britain, Connecticut, United States
        • Site 914
      • Norwalk, Connecticut, United States
        • Site 931
    • Florida
      • Miami, Florida, United States
        • Site 901
      • North Miami, Florida, United States
        • Site 907
      • Orange City, Florida, United States
        • Site 933
    • Georgia
      • Atlanta, Georgia, United States
        • Site 934
      • Blue Ridge, Georgia, United States
        • Site 917
      • Newnan, Georgia, United States
        • Site 925
    • Louisiana
      • New Orleans, Louisiana, United States
        • Site 904
      • Shreveport, Louisiana, United States
        • Site 905
      • Shreveport, Louisiana, United States
        • Site 906
    • Massachusetts
      • Bedford, Massachusetts, United States
        • Site 919
      • Boston, Massachusetts, United States
        • Site 923
    • Mississippi
      • Flowood, Mississippi, United States
        • Site 942
    • Missouri
      • St. Louis, Missouri, United States
        • Site 927
      • St. Louis, Missouri, United States
        • Site 930
      • St. Louis, Missouri, United States
        • Site 940
    • New York
      • Olean, New York, United States
        • Site 941
      • Staten Island, New York, United States
        • Site 921
    • Ohio
      • Cincinnati, Ohio, United States
        • Site 909
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • Site 908
      • Oklahoma City, Oklahoma, United States
        • Site 916
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • Site 935
    • Tennessee
      • Humboldt, Tennessee, United States
        • Site 932
    • Texas
      • Austin, Texas, United States
        • Site 936
      • Dallas, Texas, United States
        • Site 928
    • Virginia
      • Williamsburg, Virginia, United States
        • Site 913
    • Wisconsin
      • Waukesha, Wisconsin, United States
        • Site 918

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 90 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: bifeprunox
One week titration with dose adjustments
Placebo Comparator: 2
Drug: Placebo
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Brief Psychiatric Rating Scale (BPRS) Total Score
Time Frame: 10 weeks
10 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse events
Time Frame: 10 weeks
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Solvay Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 8, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Estimate)

February 9, 2015

Last Update Submitted That Met QC Criteria

January 29, 2015

Last Verified

June 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S154.3.016
  • 2005-003475-20

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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