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| Sponsored by: |
Forest Laboratories |
|---|---|
| Information provided by: | Forest Laboratories |
| ClinicalTrials.gov Identifier: | NCT00097916 |
Purpose
About 65% of patients with severe Alzheimer's Disease (AD) will have symptoms of agitation. There are drawbacks associated with the currently available therapeutic interventions for agitation associated with Alzheimer's Disease. In a recent trial, in the group of patients with moderate to severe AD treated with memantine, there were fewer incidences of agitation. It is hypothesized that memantine will be effective in reducing the symptoms of agitation associated with moderate to severe Alzheimer's Disease.
| Condition | Intervention | Phase |
|---|---|---|
|
Alzheimer's Disease |
Drug: memantine HCl |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Memantine in Non-Institutionalized Agitated Patients With Moderate to Severe Alzheimer's Disease |
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| United States, California | |
| Coastal Communities Hospital | |
| Westminster, California, United States, 92683 | |
| The Forves Norris MDA/ALS Research Center | |
| San Francisco, California, United States, 94115 | |
| United States, Connecticut | |
| Alzheimer's Disease Research Unit | |
| New Haven, Connecticut, United States, 06510 | |
| United States, Florida | |
| Berma Research Group | |
| Hialeah, Florida, United States, 33016 | |
| Premiere Research Institute | |
| West Palm Beach, Florida, United States, 33407 | |
| Baumel-Eisner Neuromedical Institute | |
| Miami, Florida, United States, 33154 | |
| United States, Hawaii | |
| Geriatric Medicine | |
| Honolulu, Hawaii, United States, 96817 | |
| United States, Vermont | |
| The Memory Clinic | |
| Bennington, Vermont, United States, 05201 | |
| United States, Virginia | |
| Hampton Roads Center for Clinical Research | |
| Norfolk, Virginia, United States, 23502 | |
More Information
| Study ID Numbers: | MEM-MD-23 |
| Study First Received: | December 1, 2004 |
| Last Updated: | December 18, 2007 |
| ClinicalTrials.gov Identifier: | NCT00097916 |
| Health Authority: | United States: Food and Drug Administration |
|
memantine HCl Dementia Agitation Alzheimer Disease |
|
Excitatory Amino Acids Alzheimer Disease Central Nervous System Diseases Psychomotor Agitation Brain Diseases Neurodegenerative Diseases Cognition Disorders |
Delirium, Dementia, Amnestic, Cognitive Disorders Dopamine Mental Disorders Memantine Dementia Delirium |
|
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Nervous System Diseases Physiological Effects of Drugs Antiparkinson Agents Excitatory Amino Acid Agents |
Pharmacologic Actions Therapeutic Uses Dopamine Agents Tauopathies Central Nervous System Agents Excitatory Amino Acid Antagonists |
