A Randomized, Double-blind, Flexible Dose, Multicenter Study to Evaluate the Effectiveness and Safety of Galantamine IR in Mild to Moderate Alzheimer's Disease

• Status: Completed
• Trial end date: 2005-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this randomized, double-blind, active-controlled, flexible dosage, multicenter study is to evaluate the effectiveness and safety of galantamine tablet (16-24mg/day) for 16 weeks in the treatment of mild to moderate Alzheimer's Disease (AD) comparing with Donepezil.

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

Details

• Lead Sponsor: Xian-Janssen Pharmaceutical Ltd.
• Treatments: Galantamine

Criteria

Inclusion Criteria:

• Out-patients diagnosed with mild to moderate probable AD. The diagnosis should have been established in accordance with the classification for probable AD of NINCDS-ADRDA

• MMSE score of 10-24 (inclusive) at screening

• Patients who lived with or had regular daily visits from a responsible caregiver

• .Has signed the informed consent form by subject and assent form by care-giver

Exclusion Criteria:

• Patients with neurodegenerative disorders such as Parkinson's disease

• Patients with some conditions possibly resulting in cognitive impairment, e.g. acute cerebral trauma, infection

• Has evidence of multi-infarct dementia or clinically active cerebrovascular disease.