Treatment of Severe Alzheimer's Disease: Evaluation of Efficacy and Safety of Galantamine Hydrobromide in a Controlled Study

• Status: Completed
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the effectiveness and safety of galantamine hydrobromide treatment in patients with severe Alzheimer's disease.

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

Details

• Lead Sponsor: Janssen Pharmaceutica N.V., Belgium
• Treatments: Galantamine

Criteria

Inclusion Criteria:

• Diagnosis of Alzheimer's type dementia, rated as severe

• progressive worsening of memory and other cognitive functions

• brain imaging (CTor MRI scan) within last 3 years

• ability to be mobile (aided or unaided) with sufficient vision and hearing to comply with testing.

Exclusion Criteria:

• Dementia caused by cerebrovascular disease

• disturbances of consciousness, delirium, psychosis

• severe aphasia

• or major sensorimotor impairment

• cognitive impairment due to acute cerebral trauma, hypoxic cerebral damage, vitamin deficiency, infections, primary of metastatic cerebral neoplasia, endocrine or metabolic disease or mental retardation, pregnant or nursing women or those without adequate contraception.