Efficacy of naftidrofuryl in patients with vascular or mixed dementia: Results of a multicenter, double-blind trial

Background: Dementia is a cerebral disorder resulting in a progressive dete rioration of intellectual function that compromises the patient's ability t o function. The diagnostic criteria for dementia are primarily clinical and are based on the Diagnostic and Statistical Manual of Mental Disorders Fou rth Edition. The Hachinski score and computed tomography of the brain help distinguish between degenerative and vascular dementias. Objective: This study examined the efficacy of naftidrofuryl in patients wi th vascular or mixed dementia. Methods: This multicenter, randomized, double-blind study compared naftidro furyl 600 mg/d with placebo for 1 year in patients with vascular or mixed d ementia. A preliminary 2-month washout period allowed selection of patients who were compliant with treatment. The end point was change in the scores on the Alzheimer Disease Assessment Scale cognitive subscale and the Mini-M ental State Examination. Results: Eighty-four patients were assessable on an intent-to-treat basis, and 74 were assessable for the per-protocol analysis (on-treatment). Statis tically significant improvements in cognitive and global function were obse rved in patients receiving naftidrofuryl. Naftidrofuryl was well tolerated, and produced no clinically significant abnormalities in laboratory test re sults. Conclusion: The results of this study suggest that naftidrofuryl is effecti ve and well tolerated in treating the symptoms of vascular and mixed dement ia.