Abstract | BACKGROUND AND PURPOSE: METHODS: In this multicenter, 28-week trial carried out in France, 321 patients received 10 mg/d memantine or placebo twice a day; 288 patients were valid for intent-to-treat analysis. Patients had to meet the criteria for probable vascular dementia and have a Mini-Mental State (MMSE) score between 12 and 20 at inclusion. The 2 primary end points were the cognitive subscale of the Alzheimers Disease Assessment Scale (ADAS-cog) and the global Clinician's Interview Based Impression of Change (CIBIC-plus). RESULTS: After 28 weeks, the mean ADAS-cog scores were significantly improved relative to placebo. In the intention-to-treat population, the memantine group mean score had gained an average of 0.4 points, whereas the placebo group mean score had declined by 1.6 points, ie, a difference of 2.0 points (95% confidence interval, 0.49 to 3.60). The response rate for CIBIC-plus, defined as improved or stable, was 60% with memantine compared with 52% with placebo (P=0.227, intention to treat). Among the secondary efficacy parameters, which were analyzed in the per-protocol subset, MMSE was significantly improved with memantine compared with deterioration with placebo (P=0.003). The Gottfries-Brane-Steen Scale intellectual function subscore and the Nurses' Observation Scale for Geriatric Patients disturbing behavior dimension also showed differences in favor of memantine (P=0.04 and P=0.07, respectively). Memantine was well tolerated with a frequency of adverse events comparable to placebo. CONCLUSIONS: In patients with mild to moderate vascular dementia, memantine 20 mg/d improved cognition consistently across different cognitive scales, with at least no deterioration in global functioning and behavior. It was devoid of concerning side effects.
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Authors | Jean-Marc Orgogozo, Anne-Sophie Rigaud, Albrecht Stöffler, Hans-Jorgen Möbius, Françoise Forette |
Journal | Stroke
(Stroke)
Vol. 33
Issue 7
Pg. 1834-9
(Jul 2002)
ISSN: 1524-4628 [Electronic] United States |
PMID | 12105362
(Publication Type: Clinical Trial, Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Dopamine Agents
- N-Methylaspartate
- Memantine
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Topics |
- Aged
- Cognition
(drug effects)
- Dementia, Vascular
(drug therapy)
- Disease Progression
- Dizziness
(etiology)
- Dopamine Agents
(adverse effects, therapeutic use)
- Double-Blind Method
- Female
- France
- Humans
- Male
- Memantine
(adverse effects, therapeutic use)
- Middle Aged
- N-Methylaspartate
(antagonists & inhibitors)
- Neuropsychological Tests
- Treatment Outcome
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