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MK0952 in Patients With Mild-to-Moderate Alzheimer's Disease (0952-004)(COMPLETED)

Primary Purpose

Alzheimer's Disease

Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
MK0952
Comparator: Placebo
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease

Eligibility Criteria

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

Inclusion Criteria: Male or females Age >/= 55 years, With mild-to-moderate AD, with MMSE between 18 and 26, inclusive, MHIS score </= 4, Global CDR score of 1 or 2 Who have a reliable informant/caregiver to accompany patient to all clinic visits If using a symptomatic AD treatments, patients must be on stable dose for >/= 6 months Exclusion Criteria: Patients must not be living in nursing home or skilled nursing facility Patients must not have current evidence and/or history of Crohn's disease, ulcerative colitis, proctitis, GI bleeding, mesenteric arteritis Patients must not have current evidence and/or history of poorly-controlled hypertension, clinically significant cardiac arrhythmia, angina, or CHF Patients must not have current evidence and/or history of a psychotic disorder or major untreated depressive disorder Patients must not have current evidence and/or history of stroke or multiple lacunar infarcts, or neurological or neurodegenerative disorder (other than AD) Various concomitant therapy restrictions

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    August 8, 2006
    Last Updated
    May 13, 2016
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00362024
    Brief Title
    MK0952 in Patients With Mild-to-Moderate Alzheimer's Disease (0952-004)(COMPLETED)
    Official Title
    MK0952 in Patients With Mild-to-Moderate Alzheimer's Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2016
    Overall Recruitment Status
    Terminated
    Study Start Date
    November 2006 (undefined)
    Primary Completion Date
    November 2007 (Actual)
    Study Completion Date
    November 2007 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    5. Study Description

    Brief Summary
    MK0952 is a phosphodiesterase type IV (PDE4) inhibitor in development for improvement of cognitive impairment in mild-to-moderate Alzheimer's disease.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alzheimer's Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    24 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    MK0952
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: Placebo

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male or females Age >/= 55 years, With mild-to-moderate AD, with MMSE between 18 and 26, inclusive, MHIS score </= 4, Global CDR score of 1 or 2 Who have a reliable informant/caregiver to accompany patient to all clinic visits If using a symptomatic AD treatments, patients must be on stable dose for >/= 6 months Exclusion Criteria: Patients must not be living in nursing home or skilled nursing facility Patients must not have current evidence and/or history of Crohn's disease, ulcerative colitis, proctitis, GI bleeding, mesenteric arteritis Patients must not have current evidence and/or history of poorly-controlled hypertension, clinically significant cardiac arrhythmia, angina, or CHF Patients must not have current evidence and/or history of a psychotic disorder or major untreated depressive disorder Patients must not have current evidence and/or history of stroke or multiple lacunar infarcts, or neurological or neurodegenerative disorder (other than AD) Various concomitant therapy restrictions
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    MK0952 in Patients With Mild-to-Moderate Alzheimer's Disease (0952-004)(COMPLETED)

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