Status:
COMPLETED
Effect of Memantine on Functional Communication in Patients With Alzheimer's Disease
Lead Sponsor:
Forest Laboratories
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
50+ years
Phase:
PHASE4
Brief Summary
The objective of this study is to evaluate the effect of memantine versus placebo on functional communication in patients with Alzheimer's Disease
Eligibility Criteria
Inclusion
- Male and female outpatients, 50 years or older, native English speakers, meeting National Institute of Neurological and Communicative Disorders and Stroke--Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria for probable AD with a Mini Mental State Examination (MMSE) score of 10 to 19 at Screening and Baseline
Exclusion
- Current Diagnostic and Statistical Manual of Mental Disorders--Fourth Edition (DSM-IV) Axis I disorder other than AD
- Previous imaging results not consistent with the diagnosis of AD
- Modified Hachinski Ischemia Score greater than 4
- Evidence of other neurologic disorders
- Clinically significant systemic disease
- A known or suspected history of alcohol or drug abuse in the past 5 years
- Taking excluded medication
- Previous treatment with commercial memantine
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
265 Patients enrolled
Trial Details
Trial ID
NCT00469456
Start Date
April 1 2007
End Date
November 1 2008
Last Update
December 24 2009
Active Locations (25)
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1
Forest Investigative Site
East Gosford, New South Wales, Australia, 2250
2
Forest Investigative Site
Hornsby, New South Wales, Australia, 2077
3
Forest Investigative Site
Kogarah, New South Wales, Australia, 2217
4
Forest Investigative Site
Newcastle, New South Wales, Australia, 2300