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

S

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

60 participants in 2 patient groups, including a placebo group

1
Experimental group
Treatment:
Drug: bifeprunox
2
Placebo Comparator group
Treatment:
Drug: Placebo

Trial contacts and locations

51

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Data sourced from clinicaltrials.gov

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