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| ID | Type | Description | Link |
|---|---|---|---|
| Gabinete Berthier y Martínez. | |||
| Lundbeck, Spain, S.A. |
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| Name | Class |
|---|---|
| H. Lundbeck A/S | INDUSTRY |
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 Memantine | Active Comparator | Patients included in this group will receive memantine alone followed by memantine combined with intensive speech-language therapy. |
|
| Group 2 | Placebo Comparator | Patients included in this group will receive placebo alone followed by memantine combined with intensive speech-language therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| memantine | Drug | Memantine was titrated in 5-mg weekly increments as recommended,from a starting dose of 5 mg/day to 20 mg/day. After the 3-week up-titration phase all patients received a fixed dose of either memantine (10 mg) or placebo twice daily without CIAT during the next 3 months (week 16). During the next 2 weeks (weeks 16-18), the drug treatment was combined with CIAT. This phase of combined treatment was followed by a 2-week period (weeks 18-20) where patients received memantine or placebo treatment alone and, finally, by a 4-week period of drug withdrawal (weeks 20-24) |
| Measure | Description | Time Frame |
|---|---|---|
| Language function (overall aphasia severity). | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Depression | 24 weeks | |
| Cognitive evaluation of language function | 24 weeks | |
| Changes in event-related potential |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marcelo L. Berthier, M.D., Ph.D | Gabinete Berthier y Martínez and Centro de Investigaciones Médico-Sanitarias (CIMES), University of Malaga | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gabinete Berthier y Martínez and Centro de Investigaciones Médico-Sanitarias (CIMES) University of Malaga | Málaga | Malaga | 29001 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12105362 | Background | Orgogozo JM, Rigaud AS, Stoffler A, Mobius HJ, Forette F. Efficacy and safety of memantine in patients with mild to moderate vascular dementia: a randomized, placebo-controlled trial (MMM 300). Stroke. 2002 Jul;33(7):1834-9. doi: 10.1161/01.str.0000020094.08790.49. | |
| 15537523 | Background | Pantoni L. Treatment of vascular dementia: evidence from trials with non-cholinergic drugs. J Neurol Sci. 2004 Nov 15;226(1-2):67-70. doi: 10.1016/j.jns.2004.09.014. |
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| ID | Term |
|---|---|
| D001037 | Aphasia |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D013064 | Speech Disorders |
| D007806 | Language Disorders |
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
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| ID | Term |
|---|---|
| D008559 | Memantine |
| ID | Term |
|---|---|
| D000547 | Amantadine |
| D000218 | Adamantane |
| D001952 | Bridged-Ring Compounds |
| D006844 | Hydrocarbons, Cyclic |
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| constraint-induced language therapy (CIAT) | Behavioral | CIAT is an intensive form of language-action therapy for aphasia performed in a small group setting. In a therapeutic game context, participants had to request objects or cards from each other and understand requests made by others. Feedback of communicative success was regularly given, along with guidance, help and reinforcement. Gesturing replacing verbal language was discouraged although gestures accompanying speech were allowed. Difficulty levels were adjusted to the patients´ communicative abilities by choosing language materials and actions and reinforcement was administered taking into account each patient´s level of performance. Communication rules were introduced by shaping and modelling. Each patient received 30 hours of therapy. |
|
|
| memantine | Drug | Memantine was titrated in 5-mg weekly increments as recommended, from a starting dose of 5 mg/day to 20 mg/day. After the 3-week up-titration phase all patients received a fixed dose of either memantine (10 mg) or placebo twice daily without CIAT during the next 3 months (week 16). During the next 2 weeks (weeks 16-18), the drug treatment was combined with CIAT. This phase of combined treatment was followed by a 2-week period (weeks 18-20) where patients received memantine or placebo treatment alone and, finally, by a 4-week period of drug withdrawal (weeks 20-24). |
|
|
| placebo | Drug | Placebo |
|
| 24 weeks |
| 12847569 | Background | Roman G. Perspectives in the treatment of vascular dementia. Drugs Today (Barc). 2000 Sep;36(9):641-53. doi: 10.1358/dot.2000.36.9.593781. |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |