Efficacy and Safety of Memantine in Moderate to Severe Alzheimer's Disease
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||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|
- 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. [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
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.
- Efficacy of Memantine on Cognition in Outpatients With Moderate to Severe Dementia of the Alzheimer's Type Using the SIB Total Score. [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
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.
- Efficacy of Memantine on Global Condition Using CIBIC-plus. [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
Clinician's Interview-Based Impression of Change-Plus Version (CIBIC-plus). Improvement evaluated with reference to Baseline.
CIBIC-plus is a global rating that is derived through an independent, comprehensive interview with the patient and caregiver by a rater who is barred from knowledge of all other psychometric test scores conducted as part of this protocol as well as from reported safety data. The rating is made on a 7-point scale ranging from "1 = marked improvement" to "7 = marked worsening". A score of "4" indicates no change.
- Efficacy of Memantine on Functioning Using ADCS-ADL - 19 Items Total Score. [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
Change from Baseline on the Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) 19-item version total score.
ADCS-ADL- 19 items version for moderate to severe AD will measure patient's functioning. This battery of ADL questions is used here to measure the functional capabilities of patients with dementia. The inventory is done by interviewing a person in close contact with the patient and covers the most usual and consistent performance of the patient over the preceding 4 weeks. Total score is from 0 to 54. The higher score, the lower impairment.
- Efficacy of Memantine on Functioning Using CMAI - Long Form Total Score. [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
Change from Baseline on the Cohen-Mansfield Agitation Inventory (CMAI) - Long Form total score.
CMAI - Long Form looks specifically at agitated behaviour in patients with cognitive impairment. It is a seven-point rating scale assessing the frequency of up to 29 agitated behaviours, ranging from "1 = Never" to "7 = Several times an hour". Rating is based on responses obtained from interviews with the caregiver. The total score ranges from 29 to 203, with a higher score reflecting more frequent behavioural disturbances.
|Study Start Date:||December 2003|
|Study Completion Date:||September 2010|
|Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
20 mg Oral Tablets Once Daily
Other Name: Ebixa®
|Placebo Comparator: Placebo||
Oral Tablets Once Daily
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 with excessive glutamate release and calcium overload in neurons. Results from clinical trials in patients with moderate to severe Alzheimer's Disease (AD) have demonstrated memantine's efficacy and safety by showing positive treatment effects on cognitive, global and functional decline.
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.
|Edmonton, Alberta, Canada, T5G 0B7|
|Canada, British Columbia|
|Kelowna, British Columbia, Canada, V1W 4V5|
|Winnipeg, Manitoba, Canada, R3M 0X9|
|Canada, New Brunswick|
|St. John, New Brunswick, Canada|
|Canada, Nova Scotia|
|Kentville, Nova Scotia, Canada, B4N 4K9|
|Pictou, Nova Scotia, Canada, B0K 1H0|
|Burlington, Ontario, Canada, L7M 4Y1|
|Orangeville, Ontario, Canada, L9W 2E1|
|Ottawa, Ontario, Canada, K1N 5C8|
|Peterborough, Ontario, Canada, K9H 2P4|
|Toronto, Ontario, Canada, M3B 2W7|
|Windsor, Ontario, Canada, N8X 5A6|
|Beauport, Quebec, Canada, G1J 2G3|
|Greenfield Park, Quebec, Canada, J4V 2J2|
|Montreal, Quebec, Canada, H1T 2M4|
|Sherbrooke, Quebec, Canada, J1J 3H5|
|Sherbrooke, Quebec, Canada, J1J 2B8|
|Vanier, Quebec, Canada, G1M 2R9|
|Verdun, Quebec, Canada, H4H 1R3|
|Regina, Saskatchewan, Canada, S4T 1A5|
|Saskatoon, Saskatchewan, Canada, S7N 0W8|
|Kelowna, Canada, V1Y 3G8|
|Penticton, Canada, V2A 5C8|
|Study Director:||Email contact via H. Lundbeck A/S||LundbeckClinicalTrials@lundbeck.com|