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

Phase 3TerminatedNCT00160147

Solvay Pharmaceuticals60 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

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

Interventions

bifeprunoxDRUG

One week titration with dose adjustments

PlaceboDRUG

Placebo

Eligibility

Sex: ALLMin age: 65 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (51)

Outcomes

Primary Outcomes

Brief Psychiatric Rating Scale (BPRS) Total Score

Time frame: 10 weeks

Secondary Outcomes

Adverse events

Time frame: 10 weeks

Data from ClinicalTrials.gov

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Site 912

Phoenix, Arizona, United States

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

Site 929

Hamden, Connecticut, United States

Site 914

New Britain, Connecticut, United States

Site 931

Norwalk, Connecticut, United States

Site 901

Miami, Florida, United States

...and 41 more locations