Velnacrine for the treatment of Alzheimer's disease: A double-blind,placebo-controlled trial
Zemlan F.P.
Bok Engelsk 1996
| Utgitt | 1996
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| Omfang | Side 1105- 1116
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| Opplysninger | The present study examines the safety and efficacy of the centrallyacting cholinesterase inhibitor, velnacrine, in treating thecognitive symptoms of Alzheimer's disease. Seven hundred thirty-fivepatients with mild-to-severe Alzheimer's disease were treated in adouble-blind, placebo-controlled study. Following the screen visit,patients were treated with velnacrine (10, 25, 50 and 75 mg t.i.d.)or placebo in a double-blind dose-ranging study to identifyvelnacrine-responsive patients and their best dose. Following placebowashout velnacrine responsive patients were randomly assigned totheir best dose of velnacrine (N = 153) or placebo (N = 156) in a sixweek double-blind dose-replication study. Primary efficacy measureswere the cognitive subscale of the Alzheimer's Disease AssessmentScale (ADAS) and the Physician's Clinical Global Impression ofChange.Statistically significant improvement was observed in both primaryefficacy measures in velnacrine-treated patients during the dose-replication study. Velnacrine patients scored better on the cognitivesubscale of the ADAS than placebo patients (P < 0.001), with patientsreceiving the highest velnacrine dose averaging a 4.1-pointimprovement with respect to screen values. Clinical Global Impressionof Change scores of velnacrine-treated patients were significantlyimproved at the end of the 6 weeks of treatment when compared tothose of placebo patients (P < 0.05), The most common side effect wasasymptomatic elevation in liver transaminase levels, which occurredamong 29% of patients. These data suggest that velnacrine producesmodest clinical improvement in a subset of patients with mild-to-severe Alzheimer's disease.
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