An international, randomized, placebo‐controlled, phase 2b clinical trial of intepirdine for dementia with Lewy bodies (HEADWAY‐DLB)
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 hundre...
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| Format: | Article |
| Language: | English |
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Wiley
2021-01-01
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| Series: | Alzheimer’s & Dementia: Translational Research & Clinical Interventions |
| Subjects: | |
| Online Access: | https://doi.org/10.1002/trc2.12171 |
| _version_ | 1798022839230529536 |
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| author | Frederick M. Lang Daniel Y. Kwon Dag Aarsland Brad Boeve Babak Tousi Mark Harnett Yi Mo Marwan Noel Sabbagh |
| author_facet | Frederick M. Lang Daniel Y. Kwon Dag Aarsland Brad Boeve Babak Tousi Mark Harnett Yi Mo Marwan Noel Sabbagh |
| author_sort | Frederick M. Lang |
| collection | DOAJ |
| description | 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: P = .1580, 70 mg/day: P = .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. |
| first_indexed | 2024-04-11T17:36:28Z |
| format | Article |
| id | doaj.art-4fd889763b924aed8fc15a4faa81bb26 |
| institution | Directory Open Access Journal |
| issn | 2352-8737 |
| language | English |
| last_indexed | 2024-04-11T17:36:28Z |
| publishDate | 2021-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | Alzheimer’s & Dementia: Translational Research & Clinical Interventions |
| spelling | doaj.art-4fd889763b924aed8fc15a4faa81bb262022-12-22T04:11:35ZengWileyAlzheimer’s & Dementia: Translational Research & Clinical Interventions2352-87372021-01-0171n/an/a10.1002/trc2.12171An international, randomized, placebo‐controlled, phase 2b clinical trial of intepirdine for dementia with Lewy bodies (HEADWAY‐DLB)Frederick M. Lang0Daniel Y. Kwon1Dag Aarsland2Brad Boeve3Babak Tousi4Mark Harnett5Yi Mo6Marwan Noel Sabbagh7Axovant Sciences New York New York USAAxovant Sciences New York New York USACentre for Age‐Related Medicine (SESAM) Stavanger University Hospital Stavanger NorwayDepartment of Neurology Mayo Clinic Rochester Minnesota USACleveland Clinic Lou Ruvo Center for Brain Health Cleveland Ohio USAAxovant Sciences New York New York USAAxovant Sciences New York New York USADepartment of Neurology University of Nevada (NLV) and Cleveland Clinic Lou Ruvo Center for Brain Health Las Vegas Nevada USAAbstract 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: P = .1580, 70 mg/day: P = .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.https://doi.org/10.1002/trc2.121715‐HT6clinical trialdementia with Lewy bodiesintepirdinephase 2b |
| spellingShingle | Frederick M. Lang Daniel Y. Kwon Dag Aarsland Brad Boeve Babak Tousi Mark Harnett Yi Mo Marwan Noel Sabbagh An international, randomized, placebo‐controlled, phase 2b clinical trial of intepirdine for dementia with Lewy bodies (HEADWAY‐DLB) Alzheimer’s & Dementia: Translational Research & Clinical Interventions 5‐HT6 clinical trial dementia with Lewy bodies intepirdine phase 2b |
| title | An international, randomized, placebo‐controlled, phase 2b clinical trial of intepirdine for dementia with Lewy bodies (HEADWAY‐DLB) |
| title_full | An international, randomized, placebo‐controlled, phase 2b clinical trial of intepirdine for dementia with Lewy bodies (HEADWAY‐DLB) |
| title_fullStr | An international, randomized, placebo‐controlled, phase 2b clinical trial of intepirdine for dementia with Lewy bodies (HEADWAY‐DLB) |
| title_full_unstemmed | An international, randomized, placebo‐controlled, phase 2b clinical trial of intepirdine for dementia with Lewy bodies (HEADWAY‐DLB) |
| title_short | An international, randomized, placebo‐controlled, phase 2b clinical trial of intepirdine for dementia with Lewy bodies (HEADWAY‐DLB) |
| title_sort | international randomized placebo controlled phase 2b clinical trial of intepirdine for dementia with lewy bodies headway dlb |
| topic | 5‐HT6 clinical trial dementia with Lewy bodies intepirdine phase 2b |
| url | https://doi.org/10.1002/trc2.12171 |
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