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

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Pharmaceutical K.K.
• Treatments: Donepezil; Galantamine

Criteria

Inclusion Criteria:

• Have diagnosis of probable Alzheimer's disease (AD) in accordance with the diagnostic criteria of NINCDS-ADRDA study group

• Have an MMSE score of 10 to 22 inclusive at screening

• Have taken donepezil stably at 5 mg/day for more than 6 months before screening

• Have progression (worsening) of impaired cognitive function 6 months or longer before screening

• Be considered medically stable by the investigator on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening

• Be medically stable on the basis of clinical laboratory tests performed at screening

Exclusion Criteria:

• Has any concurrent neurodegenerative diseases manifesting dementia other than Dementia of Alzheimer's type

• Has suspected impaired cognitive function due to a variety of causes

• Has significant health disorders or diseases according to the investigators' detailed criteria

• Has had major surgery within 52 weeks of screening, or will not have fully recovered from surgery, or planned surgery during the time the subject is expected to participate in the study

• Is a woman who is pregnant, or breast-feeding, or planning to become pregnant or is a man who plans to father a child while enrolled in this study

• Has a history of severe drug allergy or severe drug hypersensitivity

• Has a history of drug or alcohol abuse

• Used another investigational drug within 90 days of screening

• Used anti-dementia drugs marketed or being developed other than donepezil or medications containing the same active ingredients within 6 months of screening

• Is considered as ineligible by the investigator