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

Sponsor
Astellas Pharma Inc (Industry)
Overall Status
Terminated
CT.gov ID
NCT00087724
Collaborator
Astellas Pharma US, Inc. (Industry)
510
Enrollment
84
Locations
26
Duration (Months)
6.1
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
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 Start Date :
Jul 1, 2004
Actual Study Completion Date :
Sep 1, 2006

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Investigational Site Phoenix Arizona United States 85013
    2 Investigational Site Phoenix Arizona United States 85032
    3 Sun City Arizona United States 85351
    4 Investigational Site Tucson Arizona United States 85724
    5 Investigational Site Little Rock Arkansas United States 72205
    6 Investigational Site Little Rock Arkansas United States 72211
    7 Investigational Site Fresno California United States 93720
    8 Investigational Site Irvine California United States 92618
    9 Investigational Site Orange California United States 92656
    10 Investigational Site San Francisco California United States 94115
    11 Investigational Site Sherman Oaks California United States 91403
    12 Investigational Site Torrance California United States 90505
    13 Investigative Site Denver Colorado United States 80249
    14 Investigational Site Denver Colorado United States 80262
    15 Investigational Site Darien Connecticut United States 06820
    16 Investigational Site Hamden Connecticut United States 06518
    17 Hamden Connecticut United States 06518
    18 Investigational Site Stamford Connecticut United States 06902
    19 Investigational Site Fort Myers Florida United States 33912
    20 Investigational Site Hialeah Florida United States 33016
    21 Investigational Site Hollywood Florida United States 33021
    22 Investigational Site Miami Florida United States 33176
    23 Investigational Site North Miami Florida United States 33161
    24 Investigational Site Ocala Florida United States 34471
    25 Investigational Site Port Charlotte Florida United States 33952
    26 Investigational Site Sarasota Florida United States 34243
    27 Investigational Site Sebring Florida United States 33872
    28 Investigational Site Tampa Florida United States 33613
    29 West Palm Beach Florida United States 33407
    30 Investigational Site Snellville Georgia United States 30078
    31 Snellville Georgia United States 30078
    32 Investigational Site Elk Grove Illinois United States 60007
    33 Investigational Site Wichita Kansas United States 67207
    34 Investigational Site New Orleans Louisiana United States 70112
    35 Baltimore Maryland United States 21208
    36 Investigational Site Newton Massachusetts United States 02459
    37 Livonia Michigan United States 48152
    38 Hattiesburg Mississippi United States 32401
    39 Investigational Site St. Louis Missouri United States 63128
    40 Investigational Site Las Vegas Nevada United States 89102
    41 Investigational Site Long Branch New Jersey United States 07740
    42 Investigational Site Manchester New Jersey United States 08759
    43 Investigational Site Piscataway New Jersey United States 08855
    44 Investigational Site Albuquerque New Mexico United States 87102
    45 Investigational Site Albany New York United States 12208
    46 Investigational Site Buffalo New York United States 14221
    47 Investigational Site Lawrence New York United States 11559
    48 Investigational Site New York New York United States 10021
    49 Investigational Site White Plains New York United States 10605
    50 Charlotte North Carolina United States 28204
    51 Investigational Site Centerville Ohio United States 45459
    52 Investigational Site Columbus Ohio United States 43210
    53 Dayton Ohio United States 45408
    54 Investigational Site Dayton Ohio United States 45415
    55 Investigational Site Toledo Ohio United States 43623
    56 Investigational Site Oklahoma City Oklahoma United States 73112
    57 Investigational Site Tulsa Oklahoma United States 74104
    58 Investigational Site Eugene Oregon United States 97401
    59 Investigational Site Medford Oregon United States 97504
    60 Investigational Site Bala Cynwyd Pennsylvania United States 19004
    61 Investigational Site Jenkintown Pennsylvania United States 19046
    62 Investigational Site Pawtucket Rhode Island United States 02860
    63 Investigational Site Johnson City Tennessee United States 37601
    64 Investigational Site Nashville Tennessee United States 37203
    65 Investigational Site Houston Texas United States 77063
    66 Investigational Site San Antonio Texas United States 78229
    67 Investigational Site Wichita Falls Texas United States 76309
    68 Investigational Site Salt Lake City Utah United States 84121
    69 Investigational Site Bennington Vermont United States 05201
    70 Burlington Vermont United States 05401
    71 Investigational Site Norfolk Virginia United States 23507
    72 Investigational Site Milwaukee Wisconsin United States 53227
    73 Investigational Site Kelowna British Columbia Canada V1Y3G8
    74 Investigational Site Penticton British Columbia Canada V2A5C8
    75 Investigational Site Victoria British Columbia Canada V8T5G1
    76 Investigational Site Sydney Nova Scotia Canada B1P1C6
    77 Investigational Site Barrie Ontario Canada L4M4S5
    78 Investigational Site North York Ontario Canada M2J5A3
    79 Investigational Site North York Ontario Canada M6M3C5
    80 Investigational Site Ottawa Ontario Canada K1G 4C3
    81 Investigational Site Sudbury Ontario Canada P3E6B4
    82 Investigational Site Toronto Ontario Canada M6M3Z5
    83 Investigational Site Willowdale Ontario Canada M2K2Z3
    84 Investigational Site Regina Saskatchewan Canada S4T1A5

    Sponsors and Collaborators

    • Astellas Pharma Inc
    • Astellas Pharma US, Inc.

    Investigators

    • Study Director: Use Central Contact, Astellas Pharma US, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00087724
    Other Study ID Numbers:
    • 03-0-189
    First Posted:
    Jul 14, 2004
    Last Update Posted:
    Jun 7, 2012
    Last Verified:
    Jun 1, 2012
    Additional relevant MeSH terms:
    Alzheimer Disease

    Study Results

    No Results Posted as of Jun 7, 2012