Status:
COMPLETED
A Study to Evaluate the Efficacy and Safety of Galantamine in Patients With Mild Cognitive Impairment
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Dementia
Alzheimer Disease
Eligibility:
All Genders
50+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of galantamine treatment in patients with mild cognitive impairment.
Detailed Description
This is an international, multicenter, double-blind, randomized, placebo-controlled trial. Following a 4 week screening period, patients with mild cognitive impairment (MCI), who are clinically at ris...
Eligibility Criteria
Inclusion
- Clinical decline of cognitive ability consistent with mild cognitive impairment
- Delayed recall score less than or equal to 10 on New York University paragraph recall test
- Sufficient visual, hearing and communication capabilities and willingness to complete serial standard tests of cognitive function
- Have a consistent informant to accompany them on scheduled visits
- Be able to read, write and fully understand the language of the cognitive scales used in the study
Exclusion
- Contraindications for magnetic resonance imaging, for example, presence of pacemaker or presence of metal in high risk areas
- Neurodegenerative disorders such as Parkinson's disease
- Cognitive impairment resulting from acute cerebral trauma, hypoxic cerebral damage, vitamin deficiency states, infections such as meningitis or AIDS, or primary of metastatic cerebral neoplasia
- Significant endocrine or metabolic disease
- Mental retardation
- Women who are pregnant, nursing, or lacking adequate contraception
Key Trial Info
Start Date :
May 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2003
Estimated Enrollment :
974 Patients enrolled
Trial Details
Trial ID
NCT00236574
Start Date
May 1 2001
End Date
November 1 2003
Last Update
June 8 2011
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