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A Study Of Oral PF-01913539 In Patients With Mild To Moderate Alzheimer's Disease

Primary Purpose

Alzheimer's Disease, Dementia, Dimebon

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
PF-01913539 5 mg
PF-01913539 5 mg
Placebo
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring Alzheimer's disease, clinical trial, memory loss, investigational drug, neurodegenerative disease, dementia

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Mild-to-Moderate Alzheimer's disease
  • MMSE score 10-24 inclusive

Exclusion Criteria:

  • Administration of anti-dementia drugs including cholinesterase-inhibitors or NMDA receptor antagonists within 90 days
  • Complication of other causes of dementia

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    PF-01913539 5 mg three times daily

    PF-01913539 20 mg three times daily

    Placebo

    Arm Description

    PF-01913539 5 mg three times daily for 6 months

    PF-01913539 20 mg three times daily for 6 months

    Placebo three times daily for 6 months

    Outcomes

    Primary Outcome Measures

    Mean change in the Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-cog) score from baseline.
    Distribution of Clinician's Interview-Based Impression of Change plus Caregiver (CIBIC-plus) Input

    Secondary Outcome Measures

    Mean change in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADAS-ADL) score from baseline.
    Mean change in Neuropsychiatric Inventory (NPI) score from baseline.
    Mean change in Mini-Mental State Examination (MMSE) score from baseline.
    Mean change in each item of Resource Utilization In Dementia(RUD) Lite from baseline.
    Adverse events, physical examination, vital signs (blood pressure, temperature, and heart rate), 12-lead ECG, and laboratory tests (hematology, blood chemistry and urinalysis).
    Population PK parameters (CL/F, V/F, etc.)

    Full Information

    First Posted
    February 9, 2010
    Last Updated
    June 28, 2010
    Sponsor
    Pfizer
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01066481
    Brief Title
    A Study Of Oral PF-01913539 In Patients With Mild To Moderate Alzheimer's Disease
    Official Title
    A Phase 2, Multi-Center, Double-Blinded, Placebo-Controlled Safety And Efficacy Study Of Oral PF-01913539 In Patients With Mild To Moderate Alzheimer's Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2010
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    April 2010 (undefined)
    Primary Completion Date
    March 2012 (Anticipated)
    Study Completion Date
    April 2012 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Pfizer

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to demonstrate the safety and efficacy of PF-01913539 in the treatment of patients with mild-to-moderate Alzheimer's Disease. It is a 6-month study enrolling 651 patients in Japan, Hong Kong, Korea, and Republic of China. All patients completing the 6-month study will be eligible to receive PF-01913539 in an open-label extension trial (B1451031).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alzheimer's Disease, Dementia, Dimebon, Investigational Drug
    Keywords
    Alzheimer's disease, clinical trial, memory loss, investigational drug, neurodegenerative disease, dementia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    PF-01913539 5 mg three times daily
    Arm Type
    Experimental
    Arm Description
    PF-01913539 5 mg three times daily for 6 months
    Arm Title
    PF-01913539 20 mg three times daily
    Arm Type
    Experimental
    Arm Description
    PF-01913539 20 mg three times daily for 6 months
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo three times daily for 6 months
    Intervention Type
    Drug
    Intervention Name(s)
    PF-01913539 5 mg
    Intervention Description
    PF-01913539 5 mg three times daily for 6 months
    Intervention Type
    Drug
    Intervention Name(s)
    PF-01913539 5 mg
    Intervention Description
    PF-01913539 5 mg three times daily for 6 months
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo three times daily for 6 months
    Primary Outcome Measure Information:
    Title
    Mean change in the Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-cog) score from baseline.
    Time Frame
    26 weeks
    Title
    Distribution of Clinician's Interview-Based Impression of Change plus Caregiver (CIBIC-plus) Input
    Time Frame
    26 weeks
    Secondary Outcome Measure Information:
    Title
    Mean change in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADAS-ADL) score from baseline.
    Time Frame
    12, 26 weeks
    Title
    Mean change in Neuropsychiatric Inventory (NPI) score from baseline.
    Time Frame
    12, 26 weeks
    Title
    Mean change in Mini-Mental State Examination (MMSE) score from baseline.
    Time Frame
    6, 12, 18, 26 weeks
    Title
    Mean change in each item of Resource Utilization In Dementia(RUD) Lite from baseline.
    Time Frame
    12, 26 weeks
    Title
    Adverse events, physical examination, vital signs (blood pressure, temperature, and heart rate), 12-lead ECG, and laboratory tests (hematology, blood chemistry and urinalysis).
    Time Frame
    12, 26 weeks
    Title
    Population PK parameters (CL/F, V/F, etc.)
    Time Frame
    26 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Mild-to-Moderate Alzheimer's disease MMSE score 10-24 inclusive Exclusion Criteria: Administration of anti-dementia drugs including cholinesterase-inhibitors or NMDA receptor antagonists within 90 days Complication of other causes of dementia
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pfizer CT.gov Call Center
    Organizational Affiliation
    Pfizer
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Links:
    URL
    https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1451010&StudyName=A%20Study%20Of%20Oral%20PF-01913539%20In%20Patients%20With%20Mild%20To%20Moderate%20Alzheimer%27s%20%20Disease
    Description
    To obtain contact information for a study center near you, click here.

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    A Study Of Oral PF-01913539 In Patients With Mild To Moderate Alzheimer's Disease

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