Status:
TERMINATED
Efficacy and Safety of Memantine in Moderate to Severe Alzheimer's Disease
Lead Sponsor:
H. Lundbeck A/S
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
50+ years
Phase:
PHASE3
Brief Summary
The primary objective of this study is to examine the efficacy of memantine on cognition and behavioural symptoms in outpatients with moderate to severe dementia of the Alzheimer's type.
Detailed Description
Memantine is a moderate affinity, uncompetitive N-methyl-D-aspartate (NMDA) receptor antagonist. Pre-clinical studies have demonstrated that memantine can decrease the neuronal toxicity associated wit...
Eligibility Criteria
Inclusion
- Outpatients who:
- had a primary diagnosis of probable Alzheimer's Disease (AD) according to National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINDS-ADRDA) criteria, and with Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revised (DSM IV TR) criteria for dementia of the Alzheimer's type
- had moderate to severe dementia, defined as a Mini Mental State Examination (MMSE) total score \>=5 and \<=15 at screening. Before substantial protocol amendment SA04 (dated 7 October 2004) was implemented, the MMSE total score range at screening was \>=8 and \<=18. Substantial protocol amendment SA07 (dated 4 September 2009) allowed patients who had previously had an MMSE score of 16 or 17 to be re-screened \>6 months after their initial screening and, if there was documented evidence of cognitive decline, to be enrolled in the study
- had a Neuropsychiatric Inventory (NPI) total score \>=13 and an NPI agitation/aggression subitem score \>=1 at screening and baseline
- did not have vascular dementia or a modified Hachinski Ischaemia Scale score \>4 at screening
Exclusion
- Evidence of clinically significant active disease, evidence of other neurological disorders, and previous treatment with memantine
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
369 Patients enrolled
Trial Details
Trial ID
NCT00857649
Start Date
December 1 2003
End Date
September 1 2010
Last Update
December 5 2013
Active Locations (23)
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1
CA019
Edmonton, Alberta, Canada, T5G 0B7
2
CA033
Kelowna, British Columbia, Canada, V1W 4V5
3
CA034
Winnipeg, Manitoba, Canada, R3M 0X9
4
CA022
Saint John, New Brunswick, Canada