Efficacy and safety of memantine in patients with mild to
moderate vascular dementia: a randomized, placebo-controlled trial
Orgogozo JM, Rigaud AS, Stoffler A, Mobius HJ, Forette F.
BACKGROUND AND PURPOSE: Based on the hypothesis of glutamate-induced
neurotoxicity (excitotoxicity) in cerebral ischemia, this study examined the
efficacy and tolerability of memantine, an uncompetitive N-methyl-D-aspartate
antagonist, in the treatment of mild to moderate vascular dementia. 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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Stroke 2002 Jul;33(7):1834-9
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