Efficacy and Safety of Memantine in Moderate to Severe Alzheimer's Disease
NCT ID: NCT00857649
Last Updated: 2013-12-05
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
369 participants
INTERVENTIONAL
2003-12-31
2010-09-30
Brief Summary
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Detailed Description
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This 24-week randomised, double-blind, placebo-controlled, multicentre study examines the effect of memantine 20 mg, administered once daily, on cognitive and behavioural symptoms in outpatients diagnosed with moderate to severe AD and significant psychopathology.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Memantine
Memantine
20 mg Oral Tablets Once Daily
Placebo
Placebo
Oral Tablets Once Daily
Interventions
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Memantine
20 mg Oral Tablets Once Daily
Placebo
Oral Tablets Once Daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
50 Years
ALL
No
Sponsors
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H. Lundbeck A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Locations
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CA019
Edmonton, Alberta, Canada
CA033
Kelowna, British Columbia, Canada
CA034
Winnipeg, Manitoba, Canada
CA022
Saint John, New Brunswick, Canada
CA046
Kentville, Nova Scotia, Canada
CA045
Pictou, Nova Scotia, Canada
CA032
Burlington, Ontario, Canada
CA029
Orangeville, Ontario, Canada
CA004
Ottawa, Ontario, Canada
CA038
Peterborough, Ontario, Canada
CA009
Toronto, Ontario, Canada
CA037
Windsor, Ontario, Canada
CA005
Beauport, Quebec, Canada
CA023
Greenfield Park, Quebec, Canada
CA013
Montreal, Quebec, Canada
CA031
Sherbrooke, Quebec, Canada
CA012
Sherbrooke, Quebec, Canada
CA030
Vanier, Quebec, Canada
CA017
Verdun, Quebec, Canada
CA015
Regina, Saskatchewan, Canada
CA040
Saskatoon, Saskatchewan, Canada
CA043
Kelowna, , Canada
CA042
Penticton, , Canada
Countries
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References
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Herrmann N, Gauthier S, Boneva N, Lemming OM; 10158 Investigators. A randomized, double-blind, placebo-controlled trial of memantine in a behaviorally enriched sample of patients with moderate-to-severe Alzheimer's disease. Int Psychogeriatr. 2013 Jun;25(6):919-27. doi: 10.1017/S1041610213000239. Epub 2013 Mar 8.
Other Identifiers
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10158
Identifier Type: -
Identifier Source: org_study_id