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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00160147
Recruitment Status : Terminated (The study was discontinued prematurely on 25 February 2008 due to slow enrollment)
First Posted : September 12, 2005
Last Update Posted : February 9, 2015
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Psychosis and Behavioral Disturbances Associated With Dementia of the Alzheimer's Type Drug: bifeprunox Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : December 2005
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

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

Primary Outcome Measures :
  1. Brief Psychiatric Rating Scale (BPRS) Total Score [ Time Frame: 10 weeks ]

Secondary Outcome Measures :
  1. Adverse events [ Time Frame: 10 weeks ]

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Ages Eligible for Study:   65 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00160147

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

Responsible Party: Solvay Pharmaceuticals Identifier: NCT00160147     History of Changes
Other Study ID Numbers: S154.3.016
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: February 9, 2015
Last Verified: June 2009

Additional relevant MeSH terms:
Psychotic Disorders
Mental Disorders
Alzheimer Disease
Problem Behavior
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Neurodegenerative Diseases
Behavioral Symptoms