NCT00160147

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2005

Geographic Reach
5 countries

51 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2005

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

February 9, 2015

Status Verified

June 1, 2009

Enrollment Period

2.1 years

First QC Date

September 8, 2005

Last Update Submit

January 29, 2015

Conditions

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

Outcome Measures

Primary Outcomes (1)

  • Brief Psychiatric Rating Scale (BPRS) Total Score

    10 weeks

Secondary Outcomes (1)

  • Adverse events

    10 weeks

Study Arms (2)

1

EXPERIMENTAL
Drug: bifeprunox

2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

bifeprunoxDRUG

One week titration with dose adjustments

1
PlaceboDRUG

Placebo

2

Eligibility Criteria

Age65 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Diagnosis of dementia of the Alzheimer's type

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (51)

Site 912

Phoenix, Arizona, United States

Location

Site 902

Carson, California, United States

Location

Site 903

Long Beach, California, United States

Location

Site 911

Pasadena, California, United States

Location

Site 922

San Marino, California, United States

Location

Site 910

Santa Ana, California, United States

Location

Site 929

Hamden, Connecticut, United States

Location

Site 914

New Britain, Connecticut, United States

Location

Site 931

Norwalk, Connecticut, United States

Location

Site 901

Miami, Florida, United States

Location

Site 907

North Miami, Florida, United States

Location

Site 933

Orange City, Florida, United States

Location

Site 934

Atlanta, Georgia, United States

Location

Site 917

Blue Ridge, Georgia, United States

Location

Site 925

Newnan, Georgia, United States

Location

Site 904

New Orleans, Louisiana, United States

Location

Site 905

Shreveport, Louisiana, United States

Location

Site 906

Shreveport, Louisiana, United States

Location

Site 919

Bedford, Massachusetts, United States

Location

Site 923

Boston, Massachusetts, United States

Location

Site 942

Flowood, Mississippi, United States

Location

Site 927

St Louis, Missouri, United States

Location

Site 930

St Louis, Missouri, United States

Location

Site 940

St Louis, Missouri, United States

Location

Site 941

Olean, New York, United States

Location

Site 921

Staten Island, New York, United States

Location

Site 909

Cincinnati, Ohio, United States

Location

Site 908

Oklahoma City, Oklahoma, United States

Location

Site 916

Oklahoma City, Oklahoma, United States

Location

Site 935

Philadelphia, Pennsylvania, United States

Location

Site 932

Humboldt, Tennessee, United States

Location

Site 936

Austin, Texas, United States

Location

Site 928

Dallas, Texas, United States

Location

Site 913

Williamsburg, Virginia, United States

Location

Site 918

Waukesha, Wisconsin, United States

Location

Site 803

Litoměřice, Czechia

Location

Site 802

Lnáře, Czechia

Location

Site 804

Prague, Czechia

Location

Site 805

Škvorec, Czechia

Location

Site 801

Tábor, Czechia

Location

Site 807

Viljandimaa, Estonia

Location

Site 806

Voru Maakond, Estonia

Location

Site 812

Bat Yam, Israel

Location

Site 808

Beer Yaakov, Israel

Location

Site 811

Hadera, Israel

Location

Site 816

Pardes Hana, Israel

Location

Site 810

Rehovot, Israel

Location

Site 809

Tirat HaCarmel, Israel

Location

Site 814

Choroszcz, Poland

Location

Site 813

Gdansk, Poland

Location

Site 815

Torun, Poland

Location

MeSH Terms

Conditions

Psychotic Disorders

Interventions

bifeprunox

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Global Clinical Director Solvay

    Solvay Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

December 1, 2005

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

February 9, 2015

Record last verified: 2009-06

Locations

CZ(5)ES(2)US(35)IL(6)PL(3)