Clinical trial NCT00087724: A Randomized Study to Evaluate FK962 in Subjects With Mild to Moderate Alzheimer's Disease
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Alzheimer's Disease
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Astellas Pharma US, Inc.
First posted: 2004-07-14
Enrollment: 510
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Investigational Site
state: Arizona
city: Sun City
country: United States
state: Arizona
city: Tucson
country: United States
facility: Investigational Site
state: Arizona
city: Little Rock
country: United States
facility: Investigational Site
state: Arkansas
city: Little Rock
country: United States
facility: Investigational Site
state: Arkansas
city: Fresno
country: United States
facility: Investigational Site
state: California
city: Irvine
country: United States
facility: Investigational Site
state: California
city: Orange
country: United States
facility: Investigational Site
state: California
city: San Francisco
country: United States
facility: Investigational Site
state: California
city: Sherman Oaks
country: United States
facility: Investigational Site
state: California
city: Torrance
country: United States
facility: Investigational Site
state: California
city: Denver
country: United States
facility: Investigative Site
state: Colorado
city: Denver
country: United States
facility: Investigational Site
state: Colorado
city: Darien
country: United States
facility: Investigational Site
state: Connecticut
city: Hamden
country: United States
facility: Investigational Site
state: Connecticut
city: Hamden
country: United States
state: Connecticut
city: Stamford
country: United States
facility: Investigational Site
state: Connecticut
city: Fort Myers
country: United States
facility: Investigational Site
state: Florida
city: Hialeah
country: United States
facility: Investigational Site
state: Florida
city: Hollywood
country: United States
facility: Investigational Site
state: Florida
city: Miami
country: United States
facility: Investigational Site
state: Florida
city: North Miami
country: United States
facility: Investigational Site
state: Florida
city: Ocala
country: United States
facility: Investigational Site
state: Florida
city: Port Charlotte
country: United States
facility: Investigational Site
state: Florida
city: Sarasota
country: United States
facility: Investigational Site
state: Florida
city: Sebring
country: United States
facility: Investigational Site
state: Florida
city: Tampa
country: United States
facility: Investigational Site
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Snellville
country: United States
facility: Investigational Site
state: Georgia
city: Snellville
country: United States
state: Georgia
city: Elk Grove
country: United States
facility: Investigational Site
state: Illinois
city: Wichita
country: United States
facility: Investigational Site
state: Kansas
city: New Orleans
country: United States
facility: Investigational Site
state: Louisiana
city: Baltimore
country: United States
state: Maryland
city: Newton
country: United States
facility: Investigational Site
state: Massachusetts
city: Livonia
country: United States
state: Michigan
city: Hattiesburg
country: United States
state: Mississippi
city: St. Louis
country: United States
facility: Investigational Site
state: Missouri
city: Las Vegas
country: United States
facility: Investigational Site
state: Nevada
city: Long Branch
country: United States
facility: Investigational Site
state: New Jersey
city: Manchester
country: United States
facility: Investigational Site
state: New Jersey
city: Piscataway
country: United States
facility: Investigational Site
state: New Jersey
city: Albuquerque
country: United States
facility: Investigational Site
state: New Mexico
city: Albany
country: United States
facility: Investigational Site
state: New York
city: Buffalo
country: United States
facility: Investigational Site
state: New York
city: Lawrence
country: United States
facility: Investigational Site
state: New York
city: New York
country: United States
facility: Investigational Site
state: New York
city: White Plains
country: United States
facility: Investigational Site
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Centerville
country: United States
facility: Investigational Site
state: Ohio
city: Columbus
country: United States
facility: Investigational Site
state: Ohio
city: Dayton
country: United States
state: Ohio
city: Dayton
country: United States
facility: Investigational Site
state: Ohio
city: Toledo
country: United States
facility: Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: Investigational Site
state: Oklahoma
city: Tulsa
country: United States
facility: Investigational Site
state: Oklahoma
city: Eugene
country: United States
facility: Investigational Site
state: Oregon
city: Medford
country: United States
facility: Investigational Site
state: Oregon
city: Bala Cynwyd
country: United States
facility: Investigational Site
state: Pennsylvania
city: Jenkintown
country: United States
facility: Investigational Site
state: Pennsylvania
city: Pawtucket
country: United States
facility: Investigational Site
state: Rhode Island
city: Johnson City
country: United States
facility: Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Investigational Site
state: Tennessee
city: Houston
country: United States
facility: Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Investigational Site
state: Texas
city: Wichita Falls
country: United States
facility: Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: Investigational Site
state: Utah
city: Bennington
country: United States
facility: Investigational Site
state: Vermont
city: Burlington
country: United States
state: Vermont
city: Norfolk
country: United States
facility: Investigational Site
state: Virginia
city: Milwaukee
country: United States
facility: Investigational Site
state: Wisconsin
city: Kelowna
country: Canada
facility: Investigational Site
state: British Columbia
city: Penticton
country: Canada
facility: Investigational Site
state: British Columbia
city: Victoria
country: Canada
facility: Investigational Site
state: British Columbia
city: Sydney
country: Canada
facility: Investigational Site
state: Nova Scotia
city: Barrie
country: Canada
facility: Investigational Site
state: Ontario
city: North York
country: Canada
facility: Investigational Site
state: Ontario
city: North York
country: Canada
facility: Investigational Site
state: Ontario
city: Ottawa
country: Canada
facility: Investigational Site
state: Ontario
city: Sudbury
country: Canada
facility: Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Investigational Site
state: Ontario
city: Willowdale
country: Canada
facility: Investigational Site
state: Ontario
city: Regina
country: Canada
facility: Investigational Site
state: Saskatchewan
Study officials:
affiliation: Astellas Pharma US, Inc.
name: Use Central Contact
role: STUDY_DIRECTOR
References: