Neurology. 2006 Feb 14;66(3):408-10. doi: 10.1212/01.wnl.0000196466.99381.5c.
This randomized, placebo-controlled, 5-week Phase II trial evaluated the safety and tolerability of SIB-1508Y, a selective alpha4beta2 nicotinic acetylcholine receptor agonist, in 77 individuals with early Parkinson disease. Lightheadedness was a common dosage-related adverse effect at higher dosages, leading to frequent dosage reduction, drug discontinuation, and eventual trial redesign. A maximally tolerated dosage of 10 mg daily was identified. No antiparkinsonian or cognitive-enhancing effects were demonstrated in this trial.
这项随机、安慰剂对照的5周II期试验评估了选择性α4β2烟碱型乙酰胆碱受体激动剂SIB-1508Y在77例早期帕金森病患者中的安全性和耐受性。头晕是较高剂量时常见的与剂量相关的不良反应,导致频繁降低剂量、停药,并最终重新设计试验。确定了每日最大耐受剂量为10毫克。该试验未显示出抗帕金森病或认知增强作用。