A Randomized Study to Evaluate FK962 in Subjects With Mild to Moderate Alzheimer's Disease
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
1 other identifier
interventional
510
2 countries
84
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2004
84 active sites
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
Study Start
First participant enrolled
July 1, 2004
CompletedFirst Submitted
Initial submission to the registry
July 12, 2004
CompletedFirst Posted
Study publicly available on registry
July 14, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2006
CompletedJune 7, 2012
June 1, 2012
July 12, 2004
June 6, 2012
Conditions
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Astellas Pharma Inclead
- Astellas Pharma US, Inc.collaborator
Study Sites (84)
Investigational Site
Phoenix, Arizona, 85013, United States
Investigational Site
Phoenix, Arizona, 85032, United States
Unknown Facility
Sun City, Arizona, 85351, United States
Investigational Site
Tucson, Arizona, 85724, United States
Investigational Site
Little Rock, Arkansas, 72205, United States
Investigational Site
Little Rock, Arkansas, 72211, United States
Investigational Site
Fresno, California, 93720, United States
Investigational Site
Irvine, California, 92618, United States
Investigational Site
Orange, California, 92656, United States
Investigational Site
San Francisco, California, 94115, United States
Investigational Site
Sherman Oaks, California, 91403, United States
Investigational Site
Torrance, California, 90505, United States
Investigative Site
Denver, Colorado, 80249, United States
Investigational Site
Denver, Colorado, 80262, United States
Investigational Site
Darien, Connecticut, 06820, United States
Investigational Site
Hamden, Connecticut, 06518, United States
Unknown Facility
Hamden, Connecticut, 06518, United States
Investigational Site
Stamford, Connecticut, 06902, United States
Investigational Site
Fort Myers, Florida, 33912, United States
Investigational Site
Hialeah, Florida, 33016, United States
Investigational Site
Hollywood, Florida, 33021, United States
Investigational Site
Miami, Florida, 33176, United States
Investigational Site
North Miami, Florida, 33161, United States
Investigational Site
Ocala, Florida, 34471, United States
Investigational Site
Port Charlotte, Florida, 33952, United States
Investigational Site
Sarasota, Florida, 34243, United States
Investigational Site
Sebring, Florida, 33872, United States
Investigational Site
Tampa, Florida, 33613, United States
Unknown Facility
West Palm Beach, Florida, 33407, United States
Investigational Site
Snellville, Georgia, 30078, United States
Unknown Facility
Snellville, Georgia, 30078, United States
Investigational Site
Elk Grove, Illinois, 60007, United States
Investigational Site
Wichita, Kansas, 67207, United States
Investigational Site
New Orleans, Louisiana, 70112, United States
Unknown Facility
Baltimore, Maryland, 21208, United States
Investigational Site
Newton, Massachusetts, 02459, United States
Unknown Facility
Livonia, Michigan, 48152, United States
Unknown Facility
Hattiesburg, Mississippi, 32401, United States
Investigational Site
St Louis, Missouri, 63128, United States
Investigational Site
Las Vegas, Nevada, 89102, United States
Investigational Site
Long Branch, New Jersey, 07740, United States
Investigational Site
Paterson, New Jersey, 08759, United States
Investigational Site
Piscataway, New Jersey, 08855, United States
Investigational Site
Albuquerque, New Mexico, 87102, United States
Investigational Site
Albany, New York, 12208, United States
Investigational Site
Buffalo, New York, 14221, United States
Investigational Site
Lawrence, New York, 11559, United States
Investigational Site
New York, New York, 10021, United States
Investigational Site
White Plains, New York, 10605, United States
Unknown Facility
Charlotte, North Carolina, 28204, United States
Investigational Site
Centerville, Ohio, 45459, United States
Investigational Site
Columbus, Ohio, 43210, United States
Unknown Facility
Dayton, Ohio, 45408, United States
Investigational Site
Dayton, Ohio, 45415, United States
Investigational Site
Toledo, Ohio, 43623, United States
Investigational Site
Oklahoma City, Oklahoma, 73112, United States
Investigational Site
Tulsa, Oklahoma, 74104, United States
Investigational Site
Eugene, Oregon, 97401, United States
Investigational Site
Medford, Oregon, 97504, United States
Investigational Site
Bala-Cynwyd, Pennsylvania, 19004, United States
Investigational Site
Jenkintown, Pennsylvania, 19046, United States
Investigational Site
Pawtucket, Rhode Island, 02860, United States
Investigational Site
Johnson City, Tennessee, 37601, United States
Investigational Site
Nashville, Tennessee, 37203, United States
Investigational Site
Houston, Texas, 77063, United States
Investigational Site
San Antonio, Texas, 78229, United States
Investigational Site
Wichita Falls, Texas, 76309, United States
Investigational Site
Salt Lake City, Utah, 84121, United States
Investigational Site
Bennington, Vermont, 05201, United States
Unknown Facility
Burlington, Vermont, 05401, United States
Investigational Site
Norfolk, Virginia, 23507, United States
Investigational Site
Milwaukee, Wisconsin, 53227, United States
Investigational Site
Kelowna, British Columbia, V1Y3G8, Canada
Investigational Site
Penticton, British Columbia, V2A5C8, Canada
Investigational Site
Victoria, British Columbia, V8T5G1, Canada
Investigational Site
Sydney, Nova Scotia, B1P1C6, Canada
Investigational Site
Barrie, Ontario, L4M4S5, Canada
Investigational Site
Greater Sudbury, Ontario, P3E6B4, Canada
Investigational Site
North York, Ontario, M2J5A3, Canada
Investigational Site
North York, Ontario, M6M3C5, Canada
Investigational Site
Ottawa, Ontario, K1G 4C3, Canada
Investigational Site
Toronto, Ontario, M6M3Z5, Canada
Investigational Site
Willowdale, Ontario, M2K2Z3, Canada
Investigational Site
Regina, Saskatchewan, S4T1A5, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Use Central Contact
Astellas Pharma US, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 12, 2004
First Posted
July 14, 2004
Study Start
July 1, 2004
Study Completion
September 1, 2006
Last Updated
June 7, 2012
Record last verified: 2012-06