Alzheimer's Disease Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 2 Study to Evaluate the Safety and Efficacy of FK962 in Subjects With Mild to Moderate Alzheimer's Disease
| Verified date | June 2012 |
| Source | Astellas Pharma Inc |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
The purpose of this study is to evaluate the safety and efficacy of five fixed dosage levels of FK962 or placebo for 24 weeks in subjects with mild to moderate Alzheimer's disease. Patient visits are every six weeks with limited efficacy measurements at week 6 and 18.
| Status | Terminated |
| Enrollment | 510 |
| Est. completion date | September 2006 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 50 Years to 90 Years |
| Eligibility |
Inclusion Criteria: - Subject satisfies the criteria for the clinical diagnosis of probable AD - Subject has a score =< 4 on the Modified Hachinski Ischemia Scale at the screening visit Exclusion Criteria: - Subject has history or evidence of significant neurologic disease other than AD - Subject has a history of stroke - Subject has been treated for schizophrenia or recurrent mood disorder within the previous three years - Subject has a hematologic or solid malignancy diagnosed within five years prior to study entry - Subject has medically unstable COPD or asthma - Subject has end stage CHF (NYHA Class III or IV) or unstable angina - Subject has evidence of significant renal insufficiency - Subject has insulin-dependent diabetes mellitus or HbA1C>8.5% at screening |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Canada | Investigational Site | Barrie | Ontario |
| Canada | Investigational Site | Kelowna | British Columbia |
| Canada | Investigational Site | North York | Ontario |
| Canada | Investigational Site | North York | Ontario |
| Canada | Investigational Site | Ottawa | Ontario |
| Canada | Investigational Site | Penticton | British Columbia |
| Canada | Investigational Site | Regina | Saskatchewan |
| Canada | Investigational Site | Sudbury | Ontario |
| Canada | Investigational Site | Sydney | Nova Scotia |
| Canada | Investigational Site | Toronto | Ontario |
| Canada | Investigational Site | Victoria | British Columbia |
| Canada | Investigational Site | Willowdale | Ontario |
| United States | Investigational Site | Albany | New York |
| United States | Investigational Site | Albuquerque | New Mexico |
| United States | Investigational Site | Bala Cynwyd | Pennsylvania |
| United States | Investigational Site | Bennington | Vermont |
| United States | Investigational Site | Buffalo | New York |
| United States | Investigational Site | Centerville | Ohio |
| United States | Investigational Site | Columbus | Ohio |
| United States | Investigational Site | Darien | Connecticut |
| United States | Investigational Site | Dayton | Ohio |
| United States | Investigational Site | Denver | Colorado |
| United States | Investigative Site | Denver | Colorado |
| United States | Investigational Site | Elk Grove | Illinois |
| United States | Investigational Site | Eugene | Oregon |
| United States | Investigational Site | Fort Myers | Florida |
| United States | Investigational Site | Fresno | California |
| United States | Investigational Site | Hamden | Connecticut |
| United States | Investigational Site | Hialeah | Florida |
| United States | Investigational Site | Hollywood | Florida |
| United States | Investigational Site | Houston | Texas |
| United States | Investigational Site | Irvine | California |
| United States | Investigational Site | Jenkintown | Pennsylvania |
| United States | Investigational Site | Johnson City | Tennessee |
| United States | Investigational Site | Las Vegas | Nevada |
| United States | Investigational Site | Lawrence | New York |
| United States | Investigational Site | Little Rock | Arkansas |
| United States | Investigational Site | Little Rock | Arkansas |
| United States | Investigational Site | Long Branch | New Jersey |
| United States | Investigational Site | Manchester | New Jersey |
| United States | Investigational Site | Medford | Oregon |
| United States | Investigational Site | Miami | Florida |
| United States | Investigational Site | Milwaukee | Wisconsin |
| United States | Investigational Site | Nashville | Tennessee |
| United States | Investigational Site | New Orleans | Louisiana |
| United States | Investigational Site | New York | New York |
| United States | Investigational Site | Newton | Massachusetts |
| United States | Investigational Site | Norfolk | Virginia |
| United States | Investigational Site | North Miami | Florida |
| United States | Investigational Site | Ocala | Florida |
| United States | Investigational Site | Oklahoma City | Oklahoma |
| United States | Investigational Site | Orange | California |
| United States | Investigational Site | Pawtucket | Rhode Island |
| United States | Investigational Site | Phoenix | Arizona |
| United States | Investigational Site | Phoenix | Arizona |
| United States | Investigational Site | Piscataway | New Jersey |
| United States | Investigational Site | Port Charlotte | Florida |
| United States | Investigational Site | Salt Lake City | Utah |
| United States | Investigational Site | San Antonio | Texas |
| United States | Investigational Site | San Francisco | California |
| United States | Investigational Site | Sarasota | Florida |
| United States | Investigational Site | Sebring | Florida |
| United States | Investigational Site | Sherman Oaks | California |
| United States | Investigational Site | Snellville | Georgia |
| United States | Investigational Site | St. Louis | Missouri |
| United States | Investigational Site | Stamford | Connecticut |
| United States | Investigational Site | Tampa | Florida |
| United States | Investigational Site | Toledo | Ohio |
| United States | Investigational Site | Torrance | California |
| United States | Investigational Site | Tucson | Arizona |
| United States | Investigational Site | Tulsa | Oklahoma |
| United States | Investigational Site | White Plains | New York |
| United States | Investigational Site | Wichita | Kansas |
| United States | Investigational Site | Wichita Falls | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| Astellas Pharma Inc | Astellas Pharma US, Inc. |
United States, Canada,
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