Lang Frederick M, Kwon Daniel Y, Aarsland Dag, Boeve Brad, Tousi Babak, Harnett Mark, Mo Yi, Noel Sabbagh Marwan
Axovant Sciences New York New York USA.
Roivant Sciences Inc. (Roivant) New York New York USA.
Alzheimers Dement (N Y). 2021 Jun 20;7(1):e12171. doi: 10.1002/trc2.12171. eCollection 2021.
A phase 2b clinical trial, HEADWAY-DLB, was performed to assess treatment with intepirdine, a serotonin receptor antagonist, in patients with dementia with Lewy bodies (DLB).
HEADWAY-DLB was a multinational, double-blind, randomized, placebo-controlled study. Two hundred sixty-nine DLB patients were randomized to receive placebo, 70 mg/day intepirdine, or 35 mg/day intepirdine over 24 weeks. The primary endpoint was change from baseline to week 24 on the Unified Parkinson's Disease Rating Scale-Part III (UPDRS-III).
Both intepirdine groups did not demonstrate significant benefits over placebo at 24 weeks on the UPDRS-III (35 mg/day: = .1580, 70 mg/day: = .6069). All other endpoints were not significant. Intepirdine was well tolerated, with a slightly higher incidence of gastrointestinal adverse events observed in the intepirdine groups versus placebo.
Intepirdine treatment did not lead to improvements over placebo in patients with DLB. As one of the largest DLB studies to date, HEADWAY-DLB demonstrates that international trials for DLB are feasible within a reasonable timeframe.
开展了一项2b期临床试验（HEADWAY-DLB），以评估5-羟色胺受体拮抗剂因他吡定对路易体痴呆（DLB）患者的治疗效果。
HEADWAY-DLB是一项跨国、双盲、随机、安慰剂对照研究。269例DLB患者被随机分组，在24周内接受安慰剂、70毫克/天因他吡定或35毫克/天因他吡定治疗。主要终点是统一帕金森病评定量表第三部分（UPDRS-III）从基线到第24周的变化。
在第24周时，两个因他吡定组在UPDRS-III上均未显示出比安慰剂有显著益处（35毫克/天：P = 0.1580，70毫克/天：P = 0.6069）。所有其他终点均无显著差异。因他吡定耐受性良好，与安慰剂相比，因他吡定组胃肠道不良事件的发生率略高。
因他吡定治疗未使DLB患者的病情改善超过安慰剂。作为迄今为止最大的DLB研究之一，HEADWAY-DLB表明，在合理的时间范围内开展针对DLB的国际试验是可行的。
