NCT00261573

A Study of the Safety and Effectiveness of Galantamine Versus Placebo in the Treatment of Patients With Vascular Dementia or Mixed Dementia

The Safety and Efficacy of Galantamine in the Treatment of Vascular and Mixed Dementia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 593 (actual)
• Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of galantamine (a drug for treating dementia) compared to placebo in the treatment of patients with dementia related to cerebrovascular disease (vascular dementia) or dementia related to Alzheimer's disease with cerebrovascular disease ("mixed" dementia).

Detailed description

This multicenter, double-blind, placebo-controlled study will evaluate the safety and effectiveness of galantamine in patients with dementia related to cerebrovascular disease or related to Alzheimer's disease with cerebrovascular disease ("mixed" dementia). All patients will initially receive placebo for a 1-month period and then will receive galantamine (starting at a low dose and gradually increasing over 5 weeks to 12 mg twice daily) or placebo for 6 months. The primary measures of effectiveness include the change from baseline to the end of treatment in the ADAS-cog/11 score (Alzheimer's Disease Assessment Scale: sum of 11 cognitive items) and the CIBIC-plus score (Clinician's Interview Based Impression of Change - Plus Caregiver Input). Additional measures of effectiveness include the change from baseline to the end of the treatment in the ADAS-cog/13 score (Alzheimer's Disease Assessment Scale: sum of 13 cognitive items), the Disability Assessment for Dementia (DAD) score, and the Neuropsychiatric Inventory (NPI)) score. Safety evaluations (incidence of adverse events, electrocardiograms (ECGs), physical examinations, laboratory tests) will be performed throughout the study. Patients who complete the double-blind portion of the study will have the opportunity to participate in a 6-month open-label extension study in which they will receive galantamine for an additional 6 months. Effectiveness will be assessed after 6 weeks, 3 months and 6 months of open-label treatment. Safety evaluations (incidence of adverse events, ECGs, physical examinations, laboratory tests) will be performed throughout the open-label portion of the study. The study hypothesis is that galantamine will be effective in the treatment of patients with vascular or mixed dementia and will be well tolerated. Double-blind: Galantamine 12 mg or placebo by mouth twice daily for 6 months, starting at a low dose and gradually increasing over 5 weeks to the final dose; Open-label: galantamine 12 mg by mouth twice daily, starting at a low dose and gradually increasing over 6 weeks to the final dose.

Conditions

• Alzheimer Disease
• Vascular Dementia

Interventions

Type	Name	Description
DRUG	galantamine hydrobromide

Timeline

• Start date: 1998-12-01
• Completion: 2000-12-01
• First posted: 2005-12-05
• Last updated: 2011-05-18