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 deterioration of intellectual function that compromises the patient's ability to function. The diagnostic criteria for dementia are primarily clinical and are based on the Diagnostic and Statistical Manual of Mental Disorders, Fourth 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 with vascular or mixed dementia.


METHODS
This multicenter, randomized, double-blind study compared naftidrofuryl 600 mg/d with placebo for 1 year in patients with vascular or mixed dementia. 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-Mental 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). Statistically significant improvements in cognitive and global function were observed in patients receiving naftidrofuryl. Naftidrofuryl was well tolerated, and produced no clinically significant abnormalities in laboratory test results.


CONCLUSIONS
The results of this study suggest that naftidrofuryl is effective and well tolerated in treating the symptoms of vascular and mixed dementia.
Emeriau
J P
JP
Department of Internal Medicine-Geriatrics, Xavier Arnozan Hospital, Pessac, France.
Lehert
P
P
Mosnier
M
M
D000368:Aged; D000369:Aged, 80 and over; D003704:Dementia / Q000188:drug therapy*; D015140:Dementia, Vascular / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D009257:Nafronyl / Q000009:adverse effects / Q000627:therapeutic use*; D010919:Placebos; D012702:Serotonin Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
D010919:Placebos; D012702:Serotonin Antagonists; D009257:Nafronyl