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A Study of the Safety and Effectiveness of Two Doses of Galantamine Versus Placebo in the Treatment of Patients With Alzheimer's Disease

Primary Purpose

Alzheimer Disease, 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, dementia, brain disease, memory loss, galantamine, placebo, caregiver, quality of life, resource utilization

Eligibility Criteria

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

Inclusion Criteria: Outpatients with a diagnosis of Alzheimer's disease according to the National Institute of Neurological and Communicative Disorders and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria (including patients living independently in residential homes for the elderly or day patients) have mild to moderate dementia, as evidenced by a Mini-Mental Status Examination (MMSE) score of 11 - 24, and a score of at least 12 on the cognitive portion of the Alzheimer's Disease Assessment scale (ADAS-cog) history of at least a 6 months of gradual and progressive cognitive decline have a consistent informant to accompany the patient on scheduled visits Exclusion Criteria: Neurogenerative disorders such as Parkinson's disease dementia caused by small strokes or cerebrovascular disease cognitive impairment resulting from 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 epilepsy, significant psychiatric disease, active peptic ulcer, clinically significant liver, kidney or lung disorders, or heart disease females of child bearing potential without adequate contraception

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Change from baseline to the end of 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 treatment in ADAS-cog/13 and DAD scores; Concentration of drug in blood; PGWB; Health/social care resource use; Incidence of adverse events; Changes in laboratory tests, ECGs and physical examinations

    Full Information

    First Posted
    November 10, 2005
    Last Updated
    May 17, 2011
    Sponsor
    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00253201
    Brief Title
    A Study of the Safety and Effectiveness of Two Doses of Galantamine Versus Placebo in the Treatment of Patients With Alzheimer's Disease
    Official Title
    Efficacy, Tolerability and Safety of Galantamine in the Treatment of Alzheimer's Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    October 1997 (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 effectiveness of two doses of galantamine (a drug for treating dementia) versus placebo in the treatment of patients with Alzheimer's disease.
    Detailed Description
    Dementia is a chronic, progressive brain disease that may involve a number of symptoms, including memory loss and changes in personality, behavior, judgment, attention span, language and thought. The most common type of dementia is Alzheimer's disease. Over time, patients with Alzheimer's disease may lose ability to perform daily tasks related to personal care (for example, bathing, dressing, and eating) and may be unable to handle money or travel to familiar places. Several small clinical trials have shown galantamine to be safe and effective in treating the symptoms associated with Alzheimer's disease. Doses studied have ranged from 15 - 60 mg/day, with galantamine administered two or three times daily. Additional information is needed to determine the optimal dose regimen for galantamine in the treatment of Alzheimer's disease. This multicenter, double-blind, placebo-controlled study evaluates the safety and effectiveness of two doses of galantamine, each given twice daily, in the treatment of patients with Alzheimer's disease. All patients initially receive placebo for a 1-month period and then receive one of two doses of galantamine (beginning with 4 mg twice daily and gradually increasing to 12 or 16 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 (Clinician's Interview Based Impression of Change - Plus Caregiver Input) score. Additional measures of effectiveness assessed at the end of the treatment include the ADAS-cog/13 score (Alzheimer's Disease Assessment Scale: sum of 13 cognitive items) and the Disability Assessment for Dementia (DAD) score. Safety evaluations (incidence of adverse events, electrocardiograms (ECGs), physical examinations, laboratory tests) are performed throughout the study. Caregiver quality of life (Psychological General Well Being Index, (PGWB)) and health/social care resource utilization (physician and other health care professional visits, use of social services, etc.) is also assessed throughout the study by questionnaires answered by the caregivers. Blood samples are taken throughout the study to determine the concentration of drug in the blood. Patients may participate in an optional portion of the study in which their genetic material is analyzed to see if contains something that would affect the way galantamine is used by their bodies. The study hypothesis is that galantamine administered in either dose is effective in the treatment of Alzheimer's disease as compared with placebo, and is well tolerated. This study will be conducted in the United States. A companion study of exact design will be conducted internationally. Galantamine, 12 or 16 mg tablets (or placebo), by mouth twice daily for 6 months, beginning with 4 mg twice daily and gradually increasing to 12 or 16 mg twice daily.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alzheimer Disease, Dementia
    Keywords
    Alzheimer's disease, dementia, brain disease, memory loss, galantamine, placebo, caregiver, quality of life, resource utilization

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    galantamine hydrobromide
    Primary Outcome Measure Information:
    Title
    Change from baseline to the end of 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 treatment in ADAS-cog/13 and DAD scores; Concentration of drug in blood; PGWB; Health/social care resource use; Incidence of adverse events; Changes in laboratory tests, ECGs and physical examinations

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Outpatients with a diagnosis of Alzheimer's disease according to the National Institute of Neurological and Communicative Disorders and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria (including patients living independently in residential homes for the elderly or day patients) have mild to moderate dementia, as evidenced by a Mini-Mental Status Examination (MMSE) score of 11 - 24, and a score of at least 12 on the cognitive portion of the Alzheimer's Disease Assessment scale (ADAS-cog) history of at least a 6 months of gradual and progressive cognitive decline have a consistent informant to accompany the patient on scheduled visits Exclusion Criteria: Neurogenerative disorders such as Parkinson's disease dementia caused by small strokes or cerebrovascular disease cognitive impairment resulting from 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 epilepsy, significant psychiatric disease, active peptic ulcer, clinically significant liver, kidney or lung disorders, or heart disease 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
    10881250
    Citation
    Raskind MA, Peskind ER, Wessel T, Yuan W. Galantamine in AD: A 6-month randomized, placebo-controlled trial with a 6-month extension. The Galantamine USA-1 Study Group. Neurology. 2000 Jun 27;54(12):2261-8. doi: 10.1212/wnl.54.12.2261.
    Results Reference
    result
    PubMed Identifier
    14967774
    Citation
    Raskind MA, Peskind ER, Truyen L, Kershaw P, Damaraju CV. The cognitive benefits of galantamine are sustained for at least 36 months: a long-term extension trial. Arch Neurol. 2004 Feb;61(2):252-6. doi: 10.1001/archneur.61.2.252.
    Results Reference
    result
    Links:
    URL
    http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=699&filename=CR006025_CSR.pdf
    Description
    A study of the safety and effectiveness of 2 doses of galantamine in patients with Alzheimer's disease

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    A Study of the Safety and Effectiveness of Two Doses of Galantamine Versus Placebo in the Treatment of Patients With Alzheimer's Disease

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