Psychosis and Behavioral Disturbances Associated With Dementia of the Alzheimer's Type Clinical Trial
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
| Verified date | June 2009 |
| Source | Solvay Pharmaceuticals |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 60 |
| Est. completion date | January 2008 |
| Est. primary completion date | January 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 65 Years to 90 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Czech Republic | Site 803 | Litomerice | |
| Czech Republic | Site 802 | Lnare | |
| Czech Republic | Site 804 | Praha | |
| Czech Republic | Site 805 | Skvorec | |
| Czech Republic | Site 801 | Tabor | |
| Estonia | Site 807 | Viljandimaa | |
| Estonia | Site 806 | Voru Maakond | |
| Israel | Site 812 | Bat Yam | |
| Israel | Site 808 | Beer Yaakov | |
| Israel | Site 811 | Hadera | |
| Israel | Site 816 | Pardes Hana | |
| Israel | Site 810 | Rehovot | |
| Israel | Site 809 | Tirat HaCarmel | |
| Poland | Site 814 | Choroszcz | |
| Poland | Site 813 | Gdansk | |
| Poland | Site 815 | Torun | |
| United States | Site 934 | Atlanta | Georgia |
| United States | Site 936 | Austin | Texas |
| United States | Site 919 | Bedford | Massachusetts |
| United States | Site 917 | Blue Ridge | Georgia |
| United States | Site 923 | Boston | Massachusetts |
| United States | Site 902 | Carson | California |
| United States | Site 909 | Cincinnati | Ohio |
| United States | Site 928 | Dallas | Texas |
| United States | Site 942 | Flowood | Mississippi |
| United States | Site 929 | Hamden | Connecticut |
| United States | Site 932 | Humboldt | Tennessee |
| United States | Site 903 | Long Beach | California |
| United States | Site 901 | Miami | Florida |
| United States | Site 914 | New Britain | Connecticut |
| United States | Site 904 | New Orleans | Louisiana |
| United States | Site 925 | Newnan | Georgia |
| United States | Site 907 | North Miami | Florida |
| United States | Site 931 | Norwalk | Connecticut |
| United States | Site 908 | Oklahoma City | Oklahoma |
| United States | Site 916 | Oklahoma City | Oklahoma |
| United States | Site 941 | Olean | New York |
| United States | Site 933 | Orange City | Florida |
| United States | Site 911 | Pasadena | California |
| United States | Site 935 | Philadelphia | Pennsylvania |
| United States | Site 912 | Phoenix | Arizona |
| United States | Site 922 | San Marino | California |
| United States | Site 910 | Santa Ana | California |
| United States | Site 905 | Shreveport | Louisiana |
| United States | Site 906 | Shreveport | Louisiana |
| United States | Site 927 | St. Louis | Missouri |
| United States | Site 930 | St. Louis | Missouri |
| United States | Site 940 | St. Louis | Missouri |
| United States | Site 921 | Staten Island | New York |
| United States | Site 918 | Waukesha | Wisconsin |
| United States | Site 913 | Williamsburg | Virginia |
| Lead Sponsor | Collaborator |
|---|---|
| Solvay Pharmaceuticals |
United States, Czech Republic, Estonia, Israel, Poland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Brief Psychiatric Rating Scale (BPRS) Total Score | 10 weeks | Yes | |
| Secondary | Adverse events | 10 weeks | Yes |