search
Back to results

Efficacy and Safety of Rivastigmine in Patients With Mild Cognitive Impairment

Primary Purpose

Cognitive Symptoms

Status
Terminated
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Rivastigmine
Sponsored by
Novartis
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cognitive Symptoms focused on measuring Mild cognitive impairment, Alzheimer's disease, Dementia, Mild Cognitive Impairment (MCI)

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All Sexes

Inclusion Criteria: Males or females who are one year post-menopausal or without childbearing potential Between the ages of 50 and 85 years old Mild cognitive impairment confirmed by Mini Mental State Examination (MMSE) score between 23 and 27 Cooperative, able to ingest oral medication, and able to complete all aspects of the study and capable of doing so, either alone or with the aid of a responsible caregiver, according to the investigator's judgement Exclusion Criteria: A current diagnosis of cerebrovascular disease, any primary neurodegenerative disorder, or any other causes of neuropsychologic disturbances or secondary dementia A current diagnosis of epilepsy or depression, or any other diagnosis that may interfere with the patient's response to study medication An advanced, severe or unstable disease of any type that may interfere with efficacy evaluations Other protocol-defined exclusion criteria may apply.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    16 week's treatment with rivastigmine on alertness, memory, attention, cognitive flexibility, orientation and language in patients with mild cognitive impairment

    Secondary Outcome Measures

    Safety of 16 week's treatment with rivastigmine in patients with mild cognitive impairment

    Full Information

    First Posted
    August 23, 2005
    Last Updated
    December 14, 2007
    Sponsor
    Novartis
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00134953
    Brief Title
    Efficacy and Safety of Rivastigmine in Patients With Mild Cognitive Impairment
    Official Title
    Efficacy and Safety of Rivastigmine in Patients With Mild Cognitive Impairment
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2007
    Overall Recruitment Status
    Terminated
    Why Stopped
    The Principal Investigator left the clinic and there was no one who could take over this study.
    Study Start Date
    January 2003 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    May 2004 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Novartis

    4. Oversight

    5. Study Description

    Brief Summary
    This study is designed to investigate the efficacy and safety of rivastigmine compared with placebo in patients with mild cognitive impairment (MCI).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cognitive Symptoms
    Keywords
    Mild cognitive impairment, Alzheimer's disease, Dementia, Mild Cognitive Impairment (MCI)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    24 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Rivastigmine
    Primary Outcome Measure Information:
    Title
    16 week's treatment with rivastigmine on alertness, memory, attention, cognitive flexibility, orientation and language in patients with mild cognitive impairment
    Secondary Outcome Measure Information:
    Title
    Safety of 16 week's treatment with rivastigmine in patients with mild cognitive impairment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    85 Years
    Eligibility Criteria
    Inclusion Criteria: Males or females who are one year post-menopausal or without childbearing potential Between the ages of 50 and 85 years old Mild cognitive impairment confirmed by Mini Mental State Examination (MMSE) score between 23 and 27 Cooperative, able to ingest oral medication, and able to complete all aspects of the study and capable of doing so, either alone or with the aid of a responsible caregiver, according to the investigator's judgement Exclusion Criteria: A current diagnosis of cerebrovascular disease, any primary neurodegenerative disorder, or any other causes of neuropsychologic disturbances or secondary dementia A current diagnosis of epilepsy or depression, or any other diagnosis that may interfere with the patient's response to study medication An advanced, severe or unstable disease of any type that may interfere with efficacy evaluations Other protocol-defined exclusion criteria may apply.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Novartis Pharmaceuticals Corporation
    Organizational Affiliation
    Novartis Pharmaceuticals
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Efficacy and Safety of Rivastigmine in Patients With Mild Cognitive Impairment

    We'll reach out to this number within 24 hrs