Efficacy and Safety of Memantine in Moderate to Severe Alzheimer's Disease
A Randomised, Double-Blind, Parallel-Group Study Examining the Efficacy and Safety of Memantine in Patients With Moderate to Severe Dementia of the Alzheimer's Type
1 other identifier
interventional
369
1 country
23
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2003
Longer than P75 for phase_3
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2003
CompletedFirst Submitted
Initial submission to the registry
March 5, 2009
CompletedFirst Posted
Study publicly available on registry
March 6, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedResults Posted
Study results publicly available
January 9, 2012
CompletedDecember 5, 2013
November 1, 2013
6.3 years
March 5, 2009
October 26, 2011
November 12, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Efficacy of Memantine on Behavioural Symptoms in Outpatients With Moderate to Severe Dementia of the Alzheimer's Type Using the NPI - 12 Items Version Total Score.
Change from Baseline in Neuropsychiatric Inventory (NPI) total score. NPI is a validated scale that assesses behavioural disturbances in patients with dementia. The 12 item version consists of 10 behavioural and 2 neurovegetative areas. It provides both a total score as well as scores for a number of sub-scales. The frequency, severity and caregiver distress for each domain are measured. The NPI is based upon responses obtained from the caregiver. The total score is from 0 to 144. A higher score reflects more frequency and severity of the disturbances.
Baseline to Week 24
Efficacy of Memantine on Cognition in Outpatients With Moderate to Severe Dementia of the Alzheimer's Type Using the SIB Total Score.
Change from Baseline in Severe Impairment Battery (SIB) total score. SIB is a validated scale used to assess cognitive function in patients with moderate to severe dementia. Items are single words or one-step commands combined with gestures. Nine domains are assessed, and the total score is between 0 and 100. A lower total score reflects the loss of cognitive function.
Baseline to Week 24
Secondary Outcomes (3)
Efficacy of Memantine on Global Condition Using CIBIC-plus.
Baseline to Week 24
Efficacy of Memantine on Functioning Using ADCS-ADL - 19 Items Total Score.
Baseline to Week 24
Efficacy of Memantine on Functioning Using CMAI - Long Form Total Score.
Baseline to Week 24
Study Arms (2)
Memantine
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Evidence of clinically significant active disease, evidence of other neurological disorders, and previous treatment with memantine
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- H. Lundbeck A/Slead
Study Sites (23)
CA019
Edmonton, Alberta, T5G 0B7, Canada
CA033
Kelowna, British Columbia, V1W 4V5, Canada
CA034
Winnipeg, Manitoba, R3M 0X9, Canada
CA022
Saint John, New Brunswick, Canada
CA046
Kentville, Nova Scotia, B4N 4K9, Canada
CA045
Pictou, Nova Scotia, B0K 1H0, Canada
CA032
Burlington, Ontario, L7M 4Y1, Canada
CA029
Orangeville, Ontario, L9W 2E1, Canada
CA004
Ottawa, Ontario, K1N 5C8, Canada
CA038
Peterborough, Ontario, K9H 2P4, Canada
CA009
Toronto, Ontario, M3B 2W7, Canada
CA037
Windsor, Ontario, N8X 5A6, Canada
CA005
Beauport, Quebec, G1J 2G3, Canada
CA023
Greenfield Park, Quebec, J4V 2J2, Canada
CA013
Montreal, Quebec, H1T 2M4, Canada
CA031
Sherbrooke, Quebec, J1J 2B8, Canada
CA012
Sherbrooke, Quebec, J1J 3H5, Canada
CA030
Vanier, Quebec, G1M 2R9, Canada
CA017
Verdun, Quebec, H4H 1R3, Canada
CA015
Regina, Saskatchewan, S4T 1A5, Canada
CA040
Saskatoon, Saskatchewan, S7N 0W8, Canada
CA043
Kelowna, V1Y 3G8, Canada
CA042
Penticton, V2A 5C8, Canada
Related Publications (1)
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.
PMID: 23472619RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Long recruitment, premature termination, substantial protocol changes; baseline imbalances (concomitant medication and severity of agitation). Variability across sites in reported events frequency (50% of agitation reports from a single site)
Results Point of Contact
- Title
- H. Lundbeck A/S
- Organization
- H. Lundbeck A/S
Study Officials
- STUDY DIRECTOR
Email contact via H. Lundbeck A/S
LundbeckClinicalTrials@lundbeck.com
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2009
First Posted
March 6, 2009
Study Start
December 1, 2003
Primary Completion
April 1, 2010
Study Completion
September 1, 2010
Last Updated
December 5, 2013
Results First Posted
January 9, 2012
Record last verified: 2013-11