Alzheimer Disease Clinical Trial
Official title:
A Randomized Double-Blind Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Galantamine in Patients With Mild Cognitive Impairment (MCI) Clinically at Risk for Development of Clinically Probable Alzheimer's Disease
The purpose of this study is to evaluate the efficacy and safety of galantamine treatment in patients with mild cognitive impairment.
Status | Completed |
Enrollment | 1063 |
Est. completion date | December 2003 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 50 Years and older |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Memory and cognition (ADAS-COG/MCI and CDR-SB scores), global functional skills and overall severity of dementia (the CDR-SB and the overall Clinical Dementia Rating) measured at 12 and 24 months. | |||
Secondary | Digit Symbol Coding and Alzheimer's Disease Cooperative Study-ADL scale (MCI version) at 12 and 24 months. Safety assessment (reports of adverse events, laboratory values, results of physical examinations, and electrocardiograms) throughout the study. |
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