The Scandinavian Multi-Infarct Dementia Trial: a double-blind, placebo-controlled trial on nimodipine in multi-infarct dementia

Vascular dementia is a major cause of mental and physical disability in Wes tern countries. Treatment of vascular dementia is currently based on the re cognition and control of vascular risk factors, while specific drugs have n ot been approved yet. The aim of the present multinational, double-blind, p lacebo-controlled study was to evaluate the safety and efficacy of nimodipi ne administered for as long as 26 weeks in improving cognition or slowing c ognitive deterioration in patients defined as having multi-infarct dementia (DSM-III-R criteria). Two hundred and fifty-nine patients were included (1 28 nimodipine, 131 placebo), and 251 were available for the intention-to-tr eat analysis. No significant difference between drug-treated and placebo pa tients was noted on the Gottfries-Brane-Steen scale score (primary efficacy criterion), the remaining neuropsychological tests (Zahlen-Verbindungs-Tes t, Fuld-Object-Memory Evaluation, Word Fluency Test, Digit Span, Mini-Menta l State Examination), and the functional scales (index of Activity of Daily Living, Instrumental Activity of Daily Living, Rapid Disability Scale, Cli nical Dementia Rating), although the majority of changes were in favor of t he active drug group. A lower incidence of cerebrovascular and cardiac even ts was observed in the nimodipine-treated patients in comparison with the p lacebo group. This study failed to show a significant effect of nimodipine on cognitive, social or global assessments in patients defined as affected by multi-infarct dementia according to the DSM-III-R criteria. A post-hoc a nalysis (presented in an accompanying paper) suggests that nimodipine may h ave a favorable effect in the subgroup of patients defined as affected by s ubcortical (small vessel) vascular dementia. (C) 2000 Elsevier Science B.V. All rights reserved.