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

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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00160147

Enrollment

Registered

2005-09-12

Start date

2005-12-31

Completion date

2008-01-31

Last updated

2015-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DRUGbifeprunox

One week titration with dose adjustments

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

65 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Brief Psychiatric Rating Scale (BPRS) Total Score	10 weeks

Secondary

Measure	Time frame
Adverse events	10 weeks

Countries

Czechia, Estonia, Israel, Poland, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026