Safety and Efficacy of High Dose, Rapid Titration Galantamine in Patients With Alzheimer's Disease

• Status: Completed
• Trial end date: 1997-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study was to determine the safety and effectiveness of a relatively high dose of galantamine, 32 mg /day in a three-times daily dosage, compared with placebo in treating patients with Alzheimer's disease.

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

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Collaborator: Shire
• Treatments: Galantamine

Criteria

Inclusion Criteria:

• Have been meeting the diagnostic criteria of Alzheimer's disease

• mild or moderate dementia as measured by the Mini Mental State Examination (MMSE) score

• live with or have daily visits from a responsible caregiver.

Exclusion Criteria:

• Parkinson's disease

• Pick's disease

• secondary or pseudodementias

• currently diagnosed epilepsy

• history of endocrine disorder

• significant heart disease

• drug or alcohol abuse

• kidney or liver dysfunction

• women of child-bearing potential unless appropriate birth-control method is used

• sensitivity to the study drug.