search
Back to results

A Study of the Safety and Effectiveness of Galantamine Versus Placebo in the Treatment of Patients With Vascular Dementia or Mixed Dementia

Primary Purpose

Alzheimer Disease, Vascular Dementia

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
galantamine hydrobromide
Sponsored by
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease focused on measuring Alzheimer's disease with cerebrovascular disease ("mixed" dementia), probable vascular dementia, galantamine

Eligibility Criteria

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

Inclusion Criteria: Outpatients with a diagnosis of vascular dementia according to the NINDS-AIREN International Workshop criteria or with a diagnosis of "mixed" dementia (possible Alzheimer's disease with cerebrovascular disease) according to the NINCDS-ADRDA criteria mild-to-moderate dementia (score of 10 - 25 on the Mini Mental Status Exam (MMSE) and ADAS-cog score of at least 12) having the opportunity to perform activities of daily living (such as dressing, bathing, etc), including patients living independently in residential homes for the elderly had onset of disease between ages 40 - 90 have a consistent informant to accompany them on scheduled visits Exclusion Criteria: Neurogenerative disorders such as Parkinson's disease cognitive impairment resulting from conditions such as acute cerebral trauma, cerebral damage due to a lack of oxygen, vitamin deficiency, infections such as meningitis or AIDS, significant endocrine or metabolic disease, mental retardation, or a brain tumor having significant psychiatric disease, active peptic ulcer, clinically significant liver, kidney or lung disorders, or heart disease history of epilepsy, convulsions, drug abuse or alcohol abuse females of child bearing potential without adequate contraception

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Change from baseline to end of double-blind treatment in ADAS-cog/11 (Alzheimer's Disease Assessment Scale: sum of 11 cognitive items) and CIBIC-plus (Clinician's Interview Based Impression of Change - Plus Caregiver Input) scores

    Secondary Outcome Measures

    Change from baseline to the end of double-blind treatment in ADAS-cog/13, NPI, and DAD scores; Change in ADAS scores from baseline to end of open-label treatment; Incidence of adverse events; Changes in laboratory tests, ECGs and physical examinations

    Full Information

    First Posted
    December 2, 2005
    Last Updated
    May 17, 2011
    Sponsor
    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00261573
    Brief Title
    A Study of the Safety and Effectiveness of Galantamine Versus Placebo in the Treatment of Patients With Vascular Dementia or Mixed Dementia
    Official Title
    The Safety and Efficacy of Galantamine in the Treatment of Vascular and Mixed Dementia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    December 1998 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    December 2000 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the safety and efficacy of galantamine (a drug for treating dementia) compared to placebo in the treatment of patients with dementia related to cerebrovascular disease (vascular dementia) or dementia related to Alzheimer's disease with cerebrovascular disease ("mixed" dementia).
    Detailed Description
    This multicenter, double-blind, placebo-controlled study will evaluate the safety and effectiveness of galantamine in patients with dementia related to cerebrovascular disease or related to Alzheimer's disease with cerebrovascular disease ("mixed" dementia). All patients will initially receive placebo for a 1-month period and then will receive galantamine (starting at a low dose and gradually increasing over 5 weeks to 12 mg twice daily) or placebo for 6 months. The primary measures of effectiveness include the change from baseline to the end of treatment in the ADAS-cog/11 score (Alzheimer's Disease Assessment Scale: sum of 11 cognitive items) and the CIBIC-plus score (Clinician's Interview Based Impression of Change - Plus Caregiver Input). Additional measures of effectiveness include the change from baseline to the end of the treatment in the ADAS-cog/13 score (Alzheimer's Disease Assessment Scale: sum of 13 cognitive items), the Disability Assessment for Dementia (DAD) score, and the Neuropsychiatric Inventory (NPI)) score. Safety evaluations (incidence of adverse events, electrocardiograms (ECGs), physical examinations, laboratory tests) will be performed throughout the study. Patients who complete the double-blind portion of the study will have the opportunity to participate in a 6-month open-label extension study in which they will receive galantamine for an additional 6 months. Effectiveness will be assessed after 6 weeks, 3 months and 6 months of open-label treatment. Safety evaluations (incidence of adverse events, ECGs, physical examinations, laboratory tests) will be performed throughout the open-label portion of the study. The study hypothesis is that galantamine will be effective in the treatment of patients with vascular or mixed dementia and will be well tolerated. Double-blind: Galantamine 12 mg or placebo by mouth twice daily for 6 months, starting at a low dose and gradually increasing over 5 weeks to the final dose; Open-label: galantamine 12 mg by mouth twice daily, starting at a low dose and gradually increasing over 6 weeks to the final dose.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alzheimer Disease, Vascular Dementia
    Keywords
    Alzheimer's disease with cerebrovascular disease ("mixed" dementia), probable vascular dementia, galantamine

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    galantamine hydrobromide
    Primary Outcome Measure Information:
    Title
    Change from baseline to end of double-blind treatment in ADAS-cog/11 (Alzheimer's Disease Assessment Scale: sum of 11 cognitive items) and CIBIC-plus (Clinician's Interview Based Impression of Change - Plus Caregiver Input) scores
    Secondary Outcome Measure Information:
    Title
    Change from baseline to the end of double-blind treatment in ADAS-cog/13, NPI, and DAD scores; Change in ADAS scores from baseline to end of open-label treatment; Incidence of adverse events; Changes in laboratory tests, ECGs and physical examinations

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Outpatients with a diagnosis of vascular dementia according to the NINDS-AIREN International Workshop criteria or with a diagnosis of "mixed" dementia (possible Alzheimer's disease with cerebrovascular disease) according to the NINCDS-ADRDA criteria mild-to-moderate dementia (score of 10 - 25 on the Mini Mental Status Exam (MMSE) and ADAS-cog score of at least 12) having the opportunity to perform activities of daily living (such as dressing, bathing, etc), including patients living independently in residential homes for the elderly had onset of disease between ages 40 - 90 have a consistent informant to accompany them on scheduled visits Exclusion Criteria: Neurogenerative disorders such as Parkinson's disease cognitive impairment resulting from conditions such as acute cerebral trauma, cerebral damage due to a lack of oxygen, vitamin deficiency, infections such as meningitis or AIDS, significant endocrine or metabolic disease, mental retardation, or a brain tumor having significant psychiatric disease, active peptic ulcer, clinically significant liver, kidney or lung disorders, or heart disease history of epilepsy, convulsions, drug abuse or alcohol abuse females of child bearing potential without adequate contraception
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
    Organizational Affiliation
    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    11965273
    Citation
    Erkinjuntti T, Kurz A, Gauthier S, Bullock R, Lilienfeld S, Damaraju CV. Efficacy of galantamine in probable vascular dementia and Alzheimer's disease combined with cerebrovascular disease: a randomised trial. Lancet. 2002 Apr 13;359(9314):1283-90. doi: 10.1016/S0140-6736(02)08267-3.
    Results Reference
    result
    Links:
    URL
    http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=702&filename=CR006034_CSR.pdf
    Description
    A study of the safety and effectiveness of galantamine in patients with dementia

    Learn more about this trial

    A Study of the Safety and Effectiveness of Galantamine Versus Placebo in the Treatment of Patients With Vascular Dementia or Mixed Dementia

    We'll reach out to this number within 24 hrs