Status:
COMPLETED
Safety and Efficacy of High Dose, Rapid Titration Galantamine in Patients With Alzheimer's Disease
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
Shire
Conditions:
Alzheimer's Disease
Dementia
Eligibility:
All Genders
45+ years
Phase:
PHASE3
Brief 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 w...
Detailed Description
Alzheimer's disease is a progressive degenerative brain disorder that affects memory, as well as the ability to concentrate, reason, and think in abstract form. This study was designed to examine the ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 1995
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 1997
Estimated Enrollment :
554 Patients enrolled
Trial Details
Trial ID
NCT00338117
Start Date
August 1 1995
End Date
May 1 1997
Last Update
April 28 2010
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