NCT00304629

Long-term Safety and Efficacy of Galantamine in Alzheimer's Disease

Long Term Safety and Efficacy of Galantamine in Alzheimer's Disease (Extension INT-8)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 241 (actual)
• Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · Industry
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

The long-term safety and efficacy of galantamine (12 mg bid) will be documented during a one year open-label treatment in subjects with Alzheimer's Disease who completed the GAL-INT-8 trial (up to 400 eligible patients). Safety will be tracked by means of adverse event reports, laboratory parameters and physical exam. Long-term efficacy will be evaluated by means of a Alzheimer's Disease Assessment Scale(ADAS) and activities of daily living scale Disability Assessment for Dementia Scale(DAD)

Detailed description

This is a twelve-month, open-label trial in which treatment with 12 mg bid galantamine will be evaluated. Only subjects who took trial medication during the 24-month trial period of GAL-INT-8 will be eligible. Safety will be assessed by periodic physical examination, vital signs, ECG and laboratory tests and reports of adverse events. The ADAS-cognitive scale and DAD scale will be used to document long-term efficacy. Patients will be seen at 6 monthly intervals but the ADAS-cognitive scale and DAD scale will only be performed at end of trial. The treatment will consist of tablets which will contain 12 mg of galantamine. Duration of treatment equals 12 months. Patients will receive 1 tablet twice daily preferably to be taken with food (breakfast in the morning at approximately 8 AM and a snack or meal in the evening at approximately 6PM).

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DRUG	galantamine

Timeline

• Start date: 2000-03-01
• Completion: 2002-03-01
• First posted: 2006-03-20
• Last updated: 2011-02-01