NCT01478633

Evaluation of Efficacy and Safety of Galantamine in Patients With Dementia of Alzheimer's Type Who Failed to Benefit From Donepezil

Evaluation of Efficacy and Safety of Galantamine in Subjects With Dementia of Alzheimer's Type Who Failed to Benefit From Donepezil

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Janssen Pharmaceutical K.K. · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a nonrandomized (study drug is intentionally assigned), open-label (all people involved know the identity of the intervention), single-arm (one group of patients receiving the same treatment), multi-centered study of galantamine in patients with Alzheimer's disease (AD). Galantamine has been approved for treatment of mild to moderate dementia of AD. Galantamine is available as film-coated tablet in 68 countries including the United States and Europe, and is also available as oral syrup and extended-release capsule in 65 counties. In Japan, galantamine was approved in January 2011 and is available in three dosage forms of film-coated tablet, oral disintegrant tablet, and oral syrup. The target population is patients with mild to moderate dementia of Alzheimer's type (ie, Mini-Mental State Examination \[MMSE\] ranging from 10 to 22) who failed to benefit from donepezil. Patients must have diagnosis of probable AD according to the diagnostic criteria National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) study group. To ensure that at least 100 subjects complete the study, 125 subjects will be enrolled. The treatment group is to receive flexible dosing of 16 mg/day or 24 mg/day. Patients will receive the study treatment for 24 weeks in accordance with the dosing regimen specified in the protocol.

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2011-09-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2011-11-23
• Last updated: 2014-03-26

Locations

11 sites across 1 country: Japan