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

This study has been terminated.
(The study was discontinued prematurely on 25 February 2008 due to slow enrollment)
Information provided by (Responsible Party):
Solvay Pharmaceuticals Identifier:
First received: September 8, 2005
Last updated: January 29, 2015
Last verified: June 2009
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 Intervention Phase
Psychosis and Behavioral Disturbances Associated With Dementia of the Alzheimer's Type
Drug: bifeprunox
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

Further study details as provided by Solvay Pharmaceuticals:

Primary Outcome Measures:
  • Brief Psychiatric Rating Scale (BPRS) Total Score [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Adverse events [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: December 2005
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: bifeprunox
One week titration with dose adjustments
Placebo Comparator: 2 Drug: Placebo


Ages Eligible for Study:   65 Years to 90 Years   (Adult, Senior)
Genders 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00160147

  Show 51 Study Locations
Sponsors and Collaborators
Solvay Pharmaceuticals
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
  More Information

Responsible Party: Solvay Pharmaceuticals Identifier: NCT00160147     History of Changes
Other Study ID Numbers: S154.3.016  2005-003475-20 
Study First Received: September 8, 2005
Last Updated: January 29, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Psychotic Disorders
Mental Disorders
Problem Behavior
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Behavioral Symptoms
Neurodegenerative Diseases processed this record on January 17, 2017