AI Article Synopsis

  • The HEADWAY-DLB study investigated the effectiveness of intepirdine, a serotonin receptor antagonist, in treating dementia with Lewy bodies (DLB) through a phase 2b clinical trial.
  • The trial involved 269 participants who were randomly assigned to receive either a placebo, 70 mg/day intepirdine, or 35 mg/day intepirdine over a 24-week period, measuring changes in motor symptoms using the UPDRS-III scale.
  • Results showed no significant improvement for either intepirdine dose compared to placebo, indicating that while the drug was generally well-tolerated, it did not provide benefits in treating DLB symptoms.

Article Abstract

Introduction: 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).

Methods: 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).

Results: 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.

Discussion: 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.

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8215076PMC
http://dx.doi.org/10.1002/trc2.12171DOI Listing

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