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| Sponsored by: |
H. Lundbeck A/S |
|---|---|
| Information provided by: | H. Lundbeck A/S |
| ClinicalTrials.gov Identifier: | NCT00857649 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Alzheimer's Disease |
Drug: Memantine Drug: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
| 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 |
| Estimated Enrollment: | 450 |
| Study Start Date: | December 2003 |
| Estimated Study Completion Date: | October 2010 |
| Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Drug: Memantine
20mg once daily oral dose
|
| 2: Placebo Comparator |
Drug: Placebo
Once daily oral dose
|
Memantine is a moderate affinity, uncompetitive 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 20mg, administered once daily (OD), on cognitive and behavioural symptoms in outpatients diagnosed with moderate to severe AD.
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@lundbeck.com |
| Canada | |
| CA042 | Recruiting |
| Penticton, Canada, V2A 5C8 | |
| CA043 | Recruiting |
| Kelowna, Canada, V1Y 3G8 | |
| Canada, Alberta | |
| CA019 | Recruiting |
| Edmonton, Alberta, Canada, T5G 0B7 | |
| Canada, British Columbia | |
| CA033 | Recruiting |
| Kelowna, British Columbia, Canada, V1W 4V5 | |
| Canada, Manitoba | |
| CA034 | Recruiting |
| Winnipeg, Manitoba, Canada, R3M 0X9 | |
| Canada, New Brunswick | |
| CA022 | Recruiting |
| St. John, New Brunswick, Canada | |
| Canada, Nova Scotia | |
| CA045 | Recruiting |
| Pictou, Nova Scotia, Canada, B0K 1H0 | |
| CA046 | Recruiting |
| Kentville, Nova Scotia, Canada, B4N 4K9 | |
| Canada, Ontario | |
| CA004 | Recruiting |
| Ottawa, Ontario, Canada, K1N 5C8 | |
| CA009 | Recruiting |
| Toronto, Ontario, Canada, M3B 2W7 | |
| CA029 | Recruiting |
| Orangeville, Ontario, Canada, L9W 2E1 | |
| CA032 | Recruiting |
| Burlington, Ontario, Canada, L7M 4Y1 | |
| CA037 | Recruiting |
| Windsor, Ontario, Canada, N8X 5A6 | |
| CA038 | Recruiting |
| Peterborough, Ontario, Canada, K9H 2P4 | |
| Canada, Quebec | |
| CA005 | Recruiting |
| Beauport, Quebec, Canada, G1J 2G3 | |
| CA012 | Recruiting |
| Sherbrooke, Quebec, Canada, J1J 3H5 | |
| CA013 | Recruiting |
| Montreal, Quebec, Canada, H1T 2M4 | |
| CA017 | Recruiting |
| Verdun, Quebec, Canada, H4H 1R3 | |
| CA023 | Recruiting |
| Greenfield Park, Quebec, Canada, J4V 2J2 | |
| CA030 | Recruiting |
| Vanier, Quebec, Canada, G1M 2R9 | |
| CA031 | Recruiting |
| Sherbrooke, Quebec, Canada, J1J 2B8 | |
| Canada, Saskatchewan | |
| CA015 | Recruiting |
| Regina, Saskatchewan, Canada, S4T 1A5 | |
| CA040 | Recruiting |
| Saskatoon, Saskatchewan, Canada, S7N 0W8 | |
| Study Director: | Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@lundbeck.com |
More Information
| Responsible Party: | H. Lundbeck A/S ( H. Lundbeck A/S ) |
| Study ID Numbers: | 10158 |
| Study First Received: | March 5, 2009 |
| Last Updated: | April 16, 2009 |
| ClinicalTrials.gov Identifier: | NCT00857649 History of Changes |
| Health Authority: | Canada: Health Canada |
|
Alzheimer's Disease |
|
Excitatory Amino Acids Neurotransmitter Agents Alzheimer Disease Central Nervous System Diseases Brain Diseases Neurodegenerative Diseases Cognition Disorders |
Delirium, Dementia, Amnestic, Cognitive Disorders Dopamine Mental Disorders Memantine Dopamine Agents Dementia Delirium |
|
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Physiological Effects of Drugs Alzheimer Disease Nervous System Diseases Antiparkinson Agents Central Nervous System Diseases Excitatory Amino Acid Agents Brain Diseases Neurodegenerative Diseases |
Pharmacologic Actions Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Therapeutic Uses Memantine Dopamine Agents Dementia Tauopathies Central Nervous System Agents Excitatory Amino Acid Antagonists |
