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The Efficacy of Galantamine on the Attention and the Frontal Function of the Patients With Dementia of Alzheimer Type

Primary Purpose

Alzheimer Disease

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
galantamine hydrobromide
Sponsored by
Janssen Korea, Ltd., Korea
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease focused on measuring Alzheimer's disease, galantamine, attention, executive function

Eligibility Criteria

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

Inclusion Criteria: Male or female patients aged 50 years or older Alzheimer's disease according to the criteria of DSM-IV15, NINCDS-ADRDA16 Measuring standard MMSE-K 10 to 26 Patients who are literate Dementia patients being nursed by the family Patients who submitted written consent before entering into the clinical trial (the guardian consent is also effective) Exclusion Criteria: If the patient was taking AChEI (Tacrine, Donepezil, Rivastigmine) to treat dementia, the patient can enter into this clinical trial as long as he/she has not taken the drug within 15 days of the beginning of the clinical trial Neurodegenerative diseases (e.g. Parkinson's disease, Pick's disease, Huntington's disease, Down syndrome) Dementia related to head trauma and dementia related to brain damage due to cerebral hypoxia (hypoxic brain damage after cardiopulmonary resuscitation, hypoxic brain damage after surgery, hypoxic brain damage due to addiction, hypoxic brain damage due to shock) brain tumor, nerve syphilis, meningitis, encephalitis, brain tumor amentia epilepsy major psychiatric patients such as major depression and schizophrenia treatment-resistant gastric and peptic ulcer patients with clinically serious hepatic, renal, lung, endocrinal or metabolic disease(thyroid, parathyroid, pituitary, renal failure, diabetes mellitus) patients complaining of severe difficulty in urination patients who have undergone heart surgery within 6 months or patients who experienced myocardial infarction, patients with untreated congestive heart failure, patients with severe disorders in the mitral valve or aortic valve patients who have once taken the investigational drugs within the past 1 month from the beginning day of the clinical trial patients with uncontrolled diabetes mellitus (if the patient is taking medication and consults the doctor on a regular basis, he/she can participate in this clinical trial) patients who experienced hypersensitivity or allergy by a cholinesterase inhibitor patients who have not given their consent to the clinical trial, patients who are judged inappropriate to participate in this clinical trial by the investigator

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Attention and Executive function: Visual CPT, Visual Span, Color Trail Making test, Stroop test

    Secondary Outcome Measures

    Cognition: Mini-Mental Sate Examination-Korean version (MMSE-K);Activities of Daily living: Seoul- Instrumental Activities of daily livings (S-IADL);Behavior: NPI-Q;Global Change: Global Deterioration Scale (GDS)

    Full Information

    First Posted
    September 13, 2005
    Last Updated
    January 20, 2011
    Sponsor
    Janssen Korea, Ltd., Korea
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00216515
    Brief Title
    The Efficacy of Galantamine on the Attention and the Frontal Function of the Patients With Dementia of Alzheimer Type
    Official Title
    A Prospective, Open-labeled, Multicenter Study of Galantamine on the Attention and Frontal Function of the Patients With Dementia of Alzheimer Type
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2004 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    November 2005 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Janssen Korea, Ltd., Korea

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to assess the efficacy of galantamine on the attention of patients with Alzheimer's Disease, how an improvement of attention of Alzheimer's Disease patients affects their activities of daily living, and the global benefit of galantamine.
    Detailed Description
    Recent studies suggest that an attention deficit occurs at early stage of Alzheimer's disease and affects patients' activities of daily living. In other words, some patients without language or visuospatial dysfunction have severe impairment of activities of daily living, which might result from attention deficit. Another recent clinical study showed that galantamine is more effective in attention and vigilance of Alzheimer's disease patients than donepezil. The study hypothesis is that galantamine will improve attention and frontal executive function in Alzheimer's disease patients and is well-tolerated. 8 mg/day for the first 4 weeks, 16 mg for the next 8 weeks

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alzheimer Disease
    Keywords
    Alzheimer's disease, galantamine, attention, executive function

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    102 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    galantamine hydrobromide
    Primary Outcome Measure Information:
    Title
    Attention and Executive function: Visual CPT, Visual Span, Color Trail Making test, Stroop test
    Secondary Outcome Measure Information:
    Title
    Cognition: Mini-Mental Sate Examination-Korean version (MMSE-K);Activities of Daily living: Seoul- Instrumental Activities of daily livings (S-IADL);Behavior: NPI-Q;Global Change: Global Deterioration Scale (GDS)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male or female patients aged 50 years or older Alzheimer's disease according to the criteria of DSM-IV15, NINCDS-ADRDA16 Measuring standard MMSE-K 10 to 26 Patients who are literate Dementia patients being nursed by the family Patients who submitted written consent before entering into the clinical trial (the guardian consent is also effective) Exclusion Criteria: If the patient was taking AChEI (Tacrine, Donepezil, Rivastigmine) to treat dementia, the patient can enter into this clinical trial as long as he/she has not taken the drug within 15 days of the beginning of the clinical trial Neurodegenerative diseases (e.g. Parkinson's disease, Pick's disease, Huntington's disease, Down syndrome) Dementia related to head trauma and dementia related to brain damage due to cerebral hypoxia (hypoxic brain damage after cardiopulmonary resuscitation, hypoxic brain damage after surgery, hypoxic brain damage due to addiction, hypoxic brain damage due to shock) brain tumor, nerve syphilis, meningitis, encephalitis, brain tumor amentia epilepsy major psychiatric patients such as major depression and schizophrenia treatment-resistant gastric and peptic ulcer patients with clinically serious hepatic, renal, lung, endocrinal or metabolic disease(thyroid, parathyroid, pituitary, renal failure, diabetes mellitus) patients complaining of severe difficulty in urination patients who have undergone heart surgery within 6 months or patients who experienced myocardial infarction, patients with untreated congestive heart failure, patients with severe disorders in the mitral valve or aortic valve patients who have once taken the investigational drugs within the past 1 month from the beginning day of the clinical trial patients with uncontrolled diabetes mellitus (if the patient is taking medication and consults the doctor on a regular basis, he/she can participate in this clinical trial) patients who experienced hypersensitivity or allergy by a cholinesterase inhibitor patients who have not given their consent to the clinical trial, patients who are judged inappropriate to participate in this clinical trial by the investigator
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Janssen Korea, Ltd. Clinical Trial
    Organizational Affiliation
    Janssen Korea, Ltd.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    The Efficacy of Galantamine on the Attention and the Frontal Function of the Patients With Dementia of Alzheimer Type

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