Clinical trial NCT00160147: Treatment of Elderly Subjects With Psychosis and Behavioral Disturbances Associated With Dementia of the Alzheimer's Type
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Psychosis and Behavioral Disturbances Associated With Dementia of the Alzheimer's Type
Lead sponsor: Solvay Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Brief Psychiatric Rating Scale (BPRS) Total Score
timeFrame: 10 weeks
Secondary outcomes:
measure: Adverse events
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Site 912
state: Arizona
city: Carson
country: United States
facility: Site 902
state: California
city: Long Beach
country: United States
facility: Site 903
state: California
city: Pasadena
country: United States
facility: Site 911
state: California
city: San Marino
country: United States
facility: Site 922
state: California
city: Santa Ana
country: United States
facility: Site 910
state: California
city: Hamden
country: United States
facility: Site 929
state: Connecticut
city: New Britain
country: United States
facility: Site 914
state: Connecticut
city: Norwalk
country: United States
facility: Site 931
state: Connecticut
city: Miami
country: United States
facility: Site 901
state: Florida
city: North Miami
country: United States
facility: Site 907
state: Florida
city: Orange City
country: United States
facility: Site 933
state: Florida
city: Atlanta
country: United States
facility: Site 934
state: Georgia
city: Blue Ridge
country: United States
facility: Site 917
state: Georgia
city: Newnan
country: United States
facility: Site 925
state: Georgia
city: New Orleans
country: United States
facility: Site 904
state: Louisiana
city: Shreveport
country: United States
facility: Site 905
state: Louisiana
city: Shreveport
country: United States
facility: Site 906
state: Louisiana
city: Bedford
country: United States
facility: Site 919
state: Massachusetts
city: Boston
country: United States
facility: Site 923
state: Massachusetts
city: Flowood
country: United States
facility: Site 942
state: Mississippi
city: St. Louis
country: United States
facility: Site 927
state: Missouri
city: St. Louis
country: United States
facility: Site 930
state: Missouri
city: St. Louis
country: United States
facility: Site 940
state: Missouri
city: Olean
country: United States
facility: Site 941
state: New York
city: Staten Island
country: United States
facility: Site 921
state: New York
city: Cincinnati
country: United States
facility: Site 909
state: Ohio
city: Oklahoma City
country: United States
facility: Site 908
state: Oklahoma
city: Oklahoma City
country: United States
facility: Site 916
state: Oklahoma
city: Philadelphia
country: United States
facility: Site 935
state: Pennsylvania
city: Humboldt
country: United States
facility: Site 932
state: Tennessee
city: Austin
country: United States
facility: Site 936
state: Texas
city: Dallas
country: United States
facility: Site 928
state: Texas
city: Williamsburg
country: United States
facility: Site 913
state: Virginia
city: Waukesha
country: United States
facility: Site 918
state: Wisconsin
city: Litomerice
country: Czech Republic
facility: Site 803
city: Lnare
country: Czech Republic
facility: Site 802
city: Praha
country: Czech Republic
facility: Site 804
city: Skvorec
country: Czech Republic
facility: Site 805
city: Tabor
country: Czech Republic
facility: Site 801
city: Viljandimaa
country: Estonia
facility: Site 807
city: Voru Maakond
country: Estonia
facility: Site 806
city: Bat Yam
country: Israel
facility: Site 812
city: Beer Yaakov
country: Israel
facility: Site 808
city: Hadera
country: Israel
facility: Site 811
city: Pardes Hana
country: Israel
facility: Site 816
city: Rehovot
country: Israel
facility: Site 810
city: Tirat HaCarmel
country: Israel
facility: Site 809
city: Choroszcz
country: Poland
facility: Site 814
city: Gdansk
country: Poland
facility: Site 813
city: Torun
country: Poland
facility: Site 815
Study officials:
affiliation: Solvay Pharmaceuticals
name: Global Clinical Director Solvay
role: STUDY_DIRECTOR
References: