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A Cardiac Safety Study of Galantamine in the Treatment of Alzheimer's Disease.

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
galantamine
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's Disease focused on measuring Alzheimer's Disease, cardiac arrhythmias

Eligibility Criteria

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

Inclusion Criteria: Outpatients diagnosed with Alzheimer's disease in accordance with NINCDS-ADRDA (National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders Association) classification for probable Alzheimer's disease Mild/moderate dementia as evidenced by a Mini-Mental State Examination (MMSE) score ranging from 11 to 24, inclusive, at baseline History of cognitive decline that has been gradual in onset and progressive over a period of at least 6 months Evidence of sustained memory deterioration in an otherwise alert patient, plus additional impairment in at least one of these five areas: orientation, judgment and problem-solving, functioning in community affairs, functioning in home and hobbies, and functioning in personal care Patients who live with or have regular daily visits from one or more responsible caregiver who are capable of assisting with the patient's medication, able to accompany the patient for assessments, and willing to provide information about the patient.On days that the patient was sent home with a Holter monitor, the caregiver was required to stay with the patient in the same household for the 24 hour duration of the cardiac assessment to ensure that the monitor lead placement remained intact. The caregiver was to be available the following day for the return of the Holter monitoring device Patient or patient's relative, guardian or legal representative have signed the informed consent. Exclusion Criteria: Disorders such as Parkinson's disease, Pick's disease, or Huntington's chorea, Down's syndrome, Creutzfeldt-Jakob disease, Cushing's syndrome, or uncontrolled diabetes Cognitive impairment resulting from trauma, injury, or hypoxia Infection Mental retardation or dementia or clinically active cerebrovascular disease Current, clinically significant cardiovascular disease that would limit the patient's ability to complete a six-week trial.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Hourly mean heart rates and PR intervals during each of the 24-hour Holter monitoring periods; Twenty-four hour mean, minimum and maximum heart rates and PR intervals during each of the 24-hour Holter monitoring periods

    Secondary Outcome Measures

    Pharmacokinetics and other safety parameters including ECG parameters were other parameters of interest.

    Full Information

    First Posted
    March 31, 2006
    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
    NCT00309725
    Brief Title
    A Cardiac Safety Study of Galantamine in the Treatment of Alzheimer's Disease.
    Official Title
    Placebo-Controlled Evaluation of Galantamine in the Treatment of Alzheimer's Disease: A Cardiac Safety Study.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    October 1999 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    5. Study Description

    Brief Summary
    The objective of this trial was to investigate the effect of galantamine (an acetylcholinesterase inhibitor) on heart rate and PR interval (the time it takes for the heart's electrical impulse to get from the atria to the ventricles) during the administration of rapidly increasing doses and at the end of a 2-week treatment period with 32 mg per day in patients with Alzheimer's disease.
    Detailed Description
    This 6-week, double-blind, parallel group trial was also designed to detect cardiac arrhythmias and conduction disturbances, such as heart block. Holter monitors and Electrocardiograms were used to measure cardiac parameters at baseline, at the end of Week 2 (first dose of 12 mg twice daily), at the end of Week 4 (first dose of 16 mg twice daily) and at Week 6 (after 2 weeks of maximum tolerated dose allowed in the trial, i.e., 24 or 32 mg/day). Other safety data collected were adverse event reports, urine and blood analysis, vital signs and physical examination. Drug levels in the blood were also tested. Patients were randomized to receive either placebo or galantamine up to 32 mg daily (i.e., 4 mg twice daily in Week 1, 8 mg twice daily in Week 2, 12 mg twice daily in Weeks 3 and 4, and 16 mg twice daily in Weeks 5 and 6). Dosage could be reduced from 16 mg twice daily to 12 mg twice daily during the first 3 days of the 32 mg/day dosing period, if a patient could not tolerate the higher dose. This titration is more rapid and the dose is higher than currently recommended for treatment.

    6. Conditions and Keywords

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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    galantamine
    Primary Outcome Measure Information:
    Title
    Hourly mean heart rates and PR intervals during each of the 24-hour Holter monitoring periods; Twenty-four hour mean, minimum and maximum heart rates and PR intervals during each of the 24-hour Holter monitoring periods
    Secondary Outcome Measure Information:
    Title
    Pharmacokinetics and other safety parameters including ECG parameters were other parameters of interest.

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Outpatients diagnosed with Alzheimer's disease in accordance with NINCDS-ADRDA (National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders Association) classification for probable Alzheimer's disease Mild/moderate dementia as evidenced by a Mini-Mental State Examination (MMSE) score ranging from 11 to 24, inclusive, at baseline History of cognitive decline that has been gradual in onset and progressive over a period of at least 6 months Evidence of sustained memory deterioration in an otherwise alert patient, plus additional impairment in at least one of these five areas: orientation, judgment and problem-solving, functioning in community affairs, functioning in home and hobbies, and functioning in personal care Patients who live with or have regular daily visits from one or more responsible caregiver who are capable of assisting with the patient's medication, able to accompany the patient for assessments, and willing to provide information about the patient.On days that the patient was sent home with a Holter monitor, the caregiver was required to stay with the patient in the same household for the 24 hour duration of the cardiac assessment to ensure that the monitor lead placement remained intact. The caregiver was to be available the following day for the return of the Holter monitoring device Patient or patient's relative, guardian or legal representative have signed the informed consent. Exclusion Criteria: Disorders such as Parkinson's disease, Pick's disease, or Huntington's chorea, Down's syndrome, Creutzfeldt-Jakob disease, Cushing's syndrome, or uncontrolled diabetes Cognitive impairment resulting from trauma, injury, or hypoxia Infection Mental retardation or dementia or clinically active cerebrovascular disease Current, clinically significant cardiovascular disease that would limit the patient's ability to complete a six-week trial.
    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

    Links:
    URL
    http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=742&filename=CR012118_CSR.pdf
    Description
    A Cardiac Safety Study of Galantamine in the Treatment of Alzheimer's Disease

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