Tracking Information
Start Date ICMJE | May 2008 |
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Estimated Primary Completion Date | August 2014 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: May 15, 2008) | The primary efficacy criterion is the cognitive change from baseline as measured by the MMSE score at Month 24 for subjects treated with galantamine compared with those treated with matching placebo. [ Time Frame: The primary efficacy criterion is the cognitive change from baseline as measured by the MMSE score at Month 24 for subjects treated with galantamine compared with those treated with matching placebo. ] [ Designated as safety issue: Yes ] |
Original Primary Outcome Measures ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT00679627 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: May 15, 2008) | Cognitive change from baseline to Month 6 in the MMSE; change from baseline to Month 24 in DAD scores; and using the APAS-CarB, the time to change over the study in subject accommodation and time caregiver spent with subject over the previous 3 months [ Time Frame: Assess cognitive change from baseline to Month 6 in the MMSE; change from baseline to Month 24 in DAD scores; and using the APAS-CarB, the time to change over the study in subject accommodation and time caregiver spent with subject over 3 months ] [ Designated as safety issue: Yes ] |
Original Secondary Outcome Measures ICMJE | Same as current |
Descriptive Information
Brief Title ICMJE | A Double-blind, Placebo-controlled, 2-year Study of Galantamine Used to Treat Patients With Mild to Moderate Alzheimer's Disease. |
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Official Title ICMJE | A Randomized, Double-Blind, Placebo-controlled Trial of Long-term (2-year) Treatment of Galantamine in Mild to Moderately-Severe Alzheimer's Disease |
Brief Summary | The purpose of this study is to compare the effectiveness and safety of 2 years of treatment with galantamine as compared with placebo of patients who have mild to moderately severe Alzheimer's disease (AD). |
Detailed Description | This is a long-term (2-year), randomized (patients will be assigned to treatment by chance), double-blind (neither the physician nor the patient will know which treatment is assigned) study of galantamine versus placebo in subjects with mild to moderately-severe AD. Approximately 2,000 subjects will participate in this study. The study length for each subject is approximately 25.5 months. The study consists of 3 phases: a pretreatment phase, a treatment phase, and a posttreatment phase. The pretreatment phase includes a 2-week screening period (to obtain a patient's and his or her caregiver's informed consent and to confirm eligibility for the study) and a baseline visit at which subjects will be randomly assigned, in a 1 to 1 ratio, to receive either galantamine or placebo once a day in the morning. Study drug will first be dispensed at the baseline visit. The treatment phase is composed of a titration period (the study drug will be introduced gradually) and a maintenance period and includes 9 visits (3 of which are conducted by telephone). The titration period is 12 weeks long, and visits occur about every 28 days. In the first 4 weeks of the titration period, subjects will receive either 8 mg galantamine or matching placebo, and this dose will be increased to 16 mg galantamine or placebo in the second 4 weeks. The dose will then be increased to 24 mg galantamine or placebo for the final 4 weeks of the titration period if the investigator believes the subject will benefit from and will safely tolerate 24 mg/day. If not, the subject may continue to receive 16 mg galantamine or placebo through the end of the titration period. After the titration period, subjects will enter the maintenance period and continue to take study drug at the dosage they received at the end of the titration period. This dosage may be continued through the end of the study or may be changed once (either up from 16 to 24 mg or down from 24 to 16 mg), depending upon the benefit and the safety of such a change for the individual subject as judged by the investigator. No dosage will exceed 24 mg/day. The posttreatment phase includes an End-of-Study Visit that occurs at the end of the maintenance period. A follow-up telephone contact (interview) is conducted 1 month after the End-of-Study Visit. The effectiveness of galantamine will be evaluated using the following tools: the Mini-Mental State Examination (MMSE); the Disability Assessment in Dementia (DAD); and the Assessment of Patient Accommodation Status and Caregiver Burden (APAS CarB). Safety evaluations for the study include the monitoring of vital status and institutionalization status, adverse events, vital signs, weight, physical and neurologic examinations. A Data Safety Monitoring Board, external to the company, has been commissioned for this study to monitor the progress of the study and to ensure that the safety of subjects is not compromised. The effectiveness hypothesis of this study is that galantamine, 16 to 24 mg per day, is superior to placebo in reducing cognitive decline from baseline (start of study drug) as measured by the MMSE over the course of 2 years. The safety hypothesis is that the mortality rate in the galantamine 16 to 24 mg per day treatment group will be the same as that in the placebo group over the course of 2 years. Study drug is titrated starting at 8 mg/day galantamine oral capsules or matching placebo for 4 weeks, increased to 16 mg/day galantamine or placebo for 4 weeks, followed by a possible increase to 24 mg/day galantamine capsules or placebo for 4 weeks. The end dosage of this sequence is continued for the remainder of the 2-year study; however, 1 change (up from 16 to 24 mg/day or down from 24 to 16 mg/day) is allowed if the investigator judges this potentially beneficial and safe for the subject. |
Study Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Condition ICMJE |
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Intervention ICMJE |
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Study Arms / Comparison Groups |
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Recruitment Information
Recruitment Status ICMJE | Recruiting | ||||
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Estimated Enrollment ICMJE | 2000 | ||||
Estimated Completion Date | August 2014 | ||||
Estimated Primary Completion Date | August 2014 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 45 Years to 90 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | Austria, Czech Republic, Estonia, France, Germany, Greece, Latvia, Lithuania, Romania, Russian Federation, Slovakia, Slovenia, Ukraine |
Administrative Information
NCT ID ICMJE | NCT00679627 | ||||
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Responsible Party | Clinical Leader, Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | ||||
Study ID Numbers ICMJE | CR012463 | ||||
Study Sponsor ICMJE | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | ||||
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Investigators ICMJE |
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Information Provided By | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |