Status:
COMPLETED
Treatment of Severe Alzheimer's Disease: Evaluation of Efficacy and Safety of Galantamine Hydrobromide in a Controlled Study
Lead Sponsor:
Janssen Pharmaceutica N.V., Belgium
Conditions:
Dementia
Alzheimer Disease
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to assess the effectiveness and safety of galantamine hydrobromide treatment in patients with severe Alzheimer's disease.
Detailed Description
This is a multicenter, 1-year study that includes a randomized, 6-month, double-blind, placebo-controlled phase and a 6-month open-label extension of galantamine hydrobromide treatment in subjects wit...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
415 Patients enrolled
Trial Details
Trial ID
NCT00216593
Start Date
December 1 2003
End Date
March 1 2008
Last Update
June 21 2011
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