Status:
COMPLETED
A Clinical Study Evaluating the Effects of Memantine on Brain Atrophy in Patients With Alzheimer's Disease
Lead Sponsor:
H. Lundbeck A/S
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
50+ years
Phase:
PHASE4
Brief Summary
Pre-clinical studies have demonstrated that memantine can decrease the neuronal toxicity associated with excessive glutamate release and calcium overload in neurons. Previous studies have shown that m...
Detailed Description
The primary objective of this study was to evaluate the effects of memantine on the rate of brain atrophy compared to placebo in patients with AD (moderate severity) over a 1-year period. This was a m...
Eligibility Criteria
Inclusion
- Outpatients at least 50 years of age with a current diagnosis of probable AD of moderate severity (MMSE score between 12 and 20, inclusive) consistent with NINCDS-ADRDA criteria and MRI scans
- Patients must have had a knowledgeable and reliable caregiver to accompany them to all clinic visits during the study
- Patients were either on or off existing acetylcholinesterase inhibitor (AChEI) treatment provided that the treatment had been initiated \>6 months prior to screening, had stabilised with respect to dose for \>3 months, and remained fixed during the entire study. AChEI treatment could not be initiated or modified during the study
Exclusion
- The patient had evidence of clinically significant active disease (including recent myocardial infarction and uncompensated congestive heart failure \[NYHA II-IV\])
- The patient had evidence of any clinically significant neurodegenerative disease or neurological disorder other than AD
- The patient was contraindicated for MRI
- Other protocol-defined inclusion and exclusion criteria applied.
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
277 Patients enrolled
Trial Details
Trial ID
NCT00862940
Start Date
September 1 2005
End Date
April 1 2009
Last Update
September 3 2012
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