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

Solvay

Status and phase: Terminated; Phase 3

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

Treatments: Drug: bifeprunox; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00160147

S154.3.016

2005-003475-20

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 65 to 90 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: bifeprunox

2

Placebo Comparator group

Treatment:

Drug: Placebo