Status:
COMPLETED
A Study of the Safety and Effectiveness of Galantamine Versus Placebo in the Treatment of Patients With Vascular Dementia or Mixed Dementia
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Alzheimer Disease
Vascular Dementia
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief 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...
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'...
Eligibility Criteria
Inclusion
- Outpatients with a diagnosis of vascular dementia according to the NINDS-AIREN International Workshop criteria or with a diagnosis of "mixed" dementia (possible Alzheimer's disease with cerebrovascular disease) according to the NINCDS-ADRDA criteria
- mild-to-moderate dementia (score of 10 - 25 on the Mini Mental Status Exam (MMSE) and ADAS-cog score of at least 12)
- having the opportunity to perform activities of daily living (such as dressing, bathing, etc), including patients living independently in residential homes for the elderly
- had onset of disease between ages 40 - 90
- have a consistent informant to accompany them on scheduled visits
Exclusion
- Neurogenerative disorders such as Parkinson's disease
- cognitive impairment resulting from conditions such as acute cerebral trauma, cerebral damage due to a lack of oxygen, vitamin deficiency, infections such as meningitis or AIDS, significant endocrine or metabolic disease, mental retardation, or a brain tumor
- having significant psychiatric disease, active peptic ulcer, clinically significant liver, kidney or lung disorders, or heart disease
- history of epilepsy, convulsions, drug abuse or alcohol abuse
- females of child bearing potential without adequate contraception
Key Trial Info
Start Date :
December 1 1998
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2000
Estimated Enrollment :
593 Patients enrolled
Trial Details
Trial ID
NCT00261573
Start Date
December 1 1998
End Date
December 1 2000
Last Update
May 18 2011
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