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. Patients with mild cognitive impairment (MCI) who are clinically at risk for development of Alzheimer's disea...
Eligibility Criteria
Inclusion
- Clinical decline of cognitive ability consistent with mild cognitive impairment
- Delayed recall score \<= 10 on a New York University paragraph recall test
- Sufficient visual, hearing and communication capabilities and be willing 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
- 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 or metastatic cerebral neoplasia
- Epilepsy
- Significant psychiatric disease
- Peptic ulcer disease
- Clinically significant heart, lung, liver or kidney diseases
- Pregnant or nursing women or those without adequate contraception
Key Trial Info
Start Date :
May 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2003
Estimated Enrollment :
1063 Patients enrolled
Trial Details
Trial ID
NCT00236431
Start Date
May 1 2001
End Date
December 1 2003
Last Update
June 8 2011
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