Status:
COMPLETED
Placebo-Controlled Evaluation of Galantamine in the Treatment of Alzheimer's Disease: Safety and Efficacy of a Controlled-Release Formulation
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Alzheimer Disease
Dementia
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of a once daily controlled-release form of galantamine (a drug for treating dementia) versus placebo in the treatment of patients ...
Detailed Description
Dementia is a chronic, progressive brain disease that may involve a number of symptoms, including memory loss and changes in personality, behavior, judgment, attention span, language and thought. The ...
Eligibility Criteria
Inclusion
- Outpatients with a diagnosis of mild-to-moderate Alzheimer's disease according to the National Institute of Neurological and Communicative Disorders and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria (including patients living in residential homes for the elderly or day patients)
- have a Mini-Mental Status Examination (MMSE) score of 10 - 24, and a score of at least 18 on the cognitive portion of the Alzheimer's Disease Assessment scale (ADAS-cog-11) with an onset between ages 40 and 90
- history of at least a 6 months of gradual and progressive cognitive decline
- have a consistent informant to accompany the patient on scheduled visits
Exclusion
- Neurogenerative disorders such as Parkinson's disease
- cognitive impairment resulting from 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
- dementia caused by small strokes or cerebrovascular disease
- having epilepsy, significant psychiatric disease, active peptic ulcer, clinically significant liver, kidney or lung disorders, or heart disease
- females of child bearing potential without adequate contraception
Key Trial Info
Start Date :
March 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2002
Estimated Enrollment :
973 Patients enrolled
Trial Details
Trial ID
NCT00253214
Start Date
March 1 2001
End Date
July 1 2002
Last Update
May 23 2011
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