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A Randomized Study to Evaluate FK962 in Subjects with Mild to Moderate Alzheimer's Disease

This study is currently recruiting patients.

Sponsored by: Fujisawa Healthcare, Inc.
Fujisawa Pharmaceutical
Information provided by: Fujisawa Healthcare, Inc.

Purpose

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.

Condition Treatment or Intervention Phase
Alzheimer's Disease
 Drug: FK962
Phase II

MedlinePlus related topics:  Alzheimer's Caregivers;   Alzheimer's Disease
Genetics Home Reference related topics:  Alzheimer disease

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

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

Further Study Details: 

Expected Total Enrollment:  510

Study start: July 2004

Eligibility

Ages Eligible for Study:  50 Years   -   90 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

Exclusion Criteria:


Location and Contact Information

Medical Information Dept.      800-727-7003    medical_information@fujisawa.com

Arizona
      Tucson,  Arizona,  85724,  United States; Recruiting

      Phoenix,  Arizona,  85013,  United States; Recruiting

      Phoenix,  Arizona,  85013,  United States; Recruiting

      Phoenix,  Arizona,  85032,  United States; Recruiting

      Tucson,  Arizona,  85741,  United States; Recruiting

California
      Torrance,  California,  90505,  United States; Recruiting

      San Francisco,  California,  94115,  United States; Recruiting

      San Francisco,  California,  94109,  United States; Recruiting

      Santa Monica,  California,  90404,  United States; Recruiting

      Fresno,  California,  93720,  United States; Recruiting

      Orange,  California,  92656,  United States; Recruiting

Colorado
      Denver,  Colorado,  80262,  United States; Recruiting

Florida
      Port Charlotte,  Florida,  33952,  United States; Recruiting

      South Miami,  Florida,  33161,  United States; Recruiting

      Sebring,  Florida,  33872,  United States; Recruiting

      Ocala,  Florida,  34471,  United States; Recruiting

      Sarasota,  Florida,  34243,  United States; Recruiting

      Hollywood,  Florida,  33021,  United States; Recruiting

      Tampa,  Florida,  33613,  United States; Recruiting

Indiana
      Indianapolis,  Indiana,  46032,  United States; Recruiting

Kansas
      Wichita,  Kansas,  67207,  United States; Recruiting

Kentucky
      Louisville,  Kentucky,  40202,  United States; Recruiting

      Lexington,  Kentucky,  40503,  United States; Recruiting

Louisiana
      New Orleans,  Louisiana,  70112,  United States; Recruiting

Massachusetts
      Newton,  Massachusetts,  02459,  United States; Recruiting

Nevada
      Las Vegas,  Nevada,  89102,  United States; Recruiting

New Jersey
      Piscataway,  New Jersey,  08855,  United States; Recruiting

      Long Branch,  New Jersey,  07740,  United States; Recruiting

      Manchester,  New Jersey,  08759,  United States; Recruiting

New Mexico
      Albuquerque,  New Mexico,  87102,  United States; Recruiting

New York
      White Plains,  New York,  10605,  United States; Recruiting

      Lawrence,  New York,  11559,  United States; Recruiting

      Buffalo,  New York,  14221,  United States; Recruiting

      Albany,  New York,  12208,  United States; Recruiting

      New York,  New York,  10021,  United States; Recruiting

Ohio
      Dayton,  Ohio,  45415,  United States; Recruiting

      Centerville,  Ohio,  45459,  United States; Recruiting

      Columbus,  Ohio,  43210,  United States; Recruiting

Oklahoma
      Oklahoma City,  Oklahoma,  73112,  United States; Recruiting

      Oklahoma City,  Oklahoma,  73112,  United States; Recruiting

      Tulsa,  Oklahoma,  74104,  United States; Recruiting

Oregon
      Eugene,  Oregon,  97401,  United States; Recruiting

      Medford,  Oregon,  97504,  United States; Recruiting

      Eugene,  Oregon,  97401,  United States; Recruiting

Pennsylvania
      Bala Cynwyd,  Pennsylvania,  19004,  United States; Recruiting

      Jenkintown,  Pennsylvania,  19046,  United States; Recruiting

Rhode Island
      Pawtucket,  Rhode Island,  02860,  United States; Recruiting

Tennessee
      Nashville,  Tennessee,  37203,  United States; Recruiting

Texas
      San Antonio,  Texas,  78229,  United States; Recruiting

      Wichita Falls,  Texas,  76309,  United States; Recruiting

Utah
      Salt Lake City,  Utah,  84121,  United States; Recruiting

Vermont
      Bennington,  Vermont,  05201,  United States; Recruiting

Virginia
      Richmond,  Virginia,  23294,  United States; Recruiting

Canada, British Columbia
      Victoria,  British Columbia,  V8T5G1,  Canada; Recruiting

Canada, Nova Scotia
      Sydney,  Nova Scotia,  B1P1C6,  Canada; Recruiting

Canada, Ontario
      Barrie,  Ontario,  L4M4S5,  Canada; Recruiting

      Toronto,  Ontario,  M6M325,  Canada; Recruiting

      Sudbury,  Ontario,  P3E6B4,  Canada; Recruiting

Canada, Saskatchewan
      Regina,  Saskatchewan,  S4T1A5,  Canada; Recruiting

More Information

Study ID Numbers:  03-0-189
Record last reviewed:  July 2004
Record first received:  July 12, 2004
ClinicalTrials.gov Identifier:  NCT00087724
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10
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