Evaluation of Efficacy and Safety of Galantamine in Patients With Dementia of Alzheimer's Type Who Failed to Benefit From Donepezil
NCT01478633 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 102
Last updated 2014-03-26
Summary
The purpose of this study is to evaluate the efficacy and safety of galantamine in patients who failed to benefit from donepezil (patients switching from donepezil). In clinical practice, it is expected that galantamine will be used in patients switching from donepezil due to the insufficient efficacy of donepezil.
Conditions
Interventions
- DRUG
-
Galantamine
8 mg/day (4 mg twice daily) for 4 weeks, followed by 16 mg/day (8 mg twice daily) for an additional 4 weeks, followed by dose at 16 mg or increased to 24 mg (with the option of decreasing back to 16 mg) for the remainder of the study (to week 24)
Sponsors & Collaborators
-
Janssen Pharmaceutical K.K.
lead INDUSTRY
Principal Investigators
-
Janssen Pharmaceutical K. K., Japan Clinical Trial · Janssen Pharmaceutical K.K.
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 40 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-09-30
- Primary Completion
- 2013-06-30
- Completion
- 2013-06-30
Countries
- Japan
Study Locations
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