An Efficacy and Safety Study of Galantamine for the Treatment of Patients With Alzheimer's Disease.

• Status: Completed
• Trial end date: 2004-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and safety of two fixed doses (16mg/day and 24mg/day) of galantamine (a drug for treating dementia) versus placebo for the treatment of patients with Alzheimer's disease, and to investigate the dose-response.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Outpatients with a diagnosis of Alzheimer's disease according to the National Institute of Neurological and Communicative Disorders and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria

• having a Mini-Mental Status Examination (MMSE) score of 10 - 22 inclusive

• having an Alzheimer's Disease Assessment Scale - Japan cognitive subscale (ADAS-J cog) score of at least 18

• exhibiting an onset and progression of cognitive dysfunction during at least 6 months prior to the screening period

Exclusion Criteria:

• Patients with neurodegenerative diseases other than Alzheimer's disease, such as Lewy bodies disease, (dementia due to tiny round structures made of proteins that develop within nerve cells in the brain), Parkinsonism, etc

• Patients with cognitive dysfunction due to cerebral damage resulting from a lack of oxygen, a brain injury, etc

• Patients with multi-infarct dementia (brought on by a series of strokes) or active cerebrovascular disease

• Patients with clinically significant cardiovascular disease

• Patients currently taking drugs such as a cholinesterase inhibitors, which improve cerebral circulation/metabolism