ArticleAlzheimer's & dementia (New York, N. Y.)2021
An international, randomized, placebo-controlled, phase 2b clinical trial of intepirdine for dementia with Lewy bodies (HEADWAY-DLB).
Article in Alzheimer's & dementia (New York, N. Y.), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
8 citing papers in PubMed, 14 citations in OpenAlex.
- Progress in Investigational Agents Targeting Serotonin-6 Receptors for the Treatment of Brain Disorders.Biomolecules · 2023Review
- Race and Ethnicity in Lewy Body Dementia: A Narrative Review.Journal of Alzheimer's disease : JAD · 2023Review
- Clinical outcome measures in dementia with Lewy bodies trials: critique and recommendations.Translational neurodegeneration · 2022Review
- Effect of masupirdine (SUVN-502) on cognition in patients with moderate Alzheimer's disease: A randomized, double-blind, phase 2, proof-of-concept study.Alzheimer's & dementia (New York, N. Y.) · 2022Article
- An international, randomized, placebo-controlled, phase 2b clinical trial of intepirdine for dementia with Lewy bodies (HEADWAY-DLB).Alzheimer's & dementia (New York, N. Y.) · 2021Article
- Advances in dementia with Lewy bodies.Therapeutic advances in neurological disorders · 2021Review
- Exploring the role of statin interventions on cognitive function by Mendelian randomization study.Journal of Alzheimer's disease reportsArticle
- Listening session with the US Food and Drug Administration, Lewy Body Dementia Association, and an expert panel.Alzheimer's & dementia (New York, N. Y.)Article
Corrections and comments
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Authors and funding
8 authors at 6 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionA 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).
methodsHEADWAY-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).
resultsBoth intepirdine groups did not demonstrate significant benefits over placebo at 24 weeks on the UPDRS-III (35 mg/day: 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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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.