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REIMAGINE: A central nervous system basket trial showing safety and efficacy of vafidemstat on aggression in different psychiatric disorders.

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Title: REIMAGINE: A central nervous system basket trial showing safety and efficacy of vafidemstat on aggression in different psychiatric disorders.
Authors: Ferrer, Marc (AUTHOR), Richarte, Vanesa (AUTHOR), Gisbert, Laura (AUTHOR), Xaus, Jordi (AUTHOR), Gutierrez, Sonia (AUTHOR), Arevalo, Maria Isabel (AUTHOR), Ropacki, Michael (AUTHOR), Bullock, Roger (AUTHOR), Buesa, Carlos (AUTHOR), Ramos‐Quiroga, Josep Antoni (AUTHOR)
Source: Psychiatry & Clinical Neurosciences. May2025, Vol. 79 Issue 5, p257-265. 9p.
Subjects: Aggression (Psychology), Borderline personality disorder, Autism spectrum disorders, Mental illness, Histone demethylases, Patient safety, Attention-deficit hyperactivity disorder, Clinical trials
Abstract: Aim: Vafidemstat is a brain‐penetrant, orally bioavailable, small molecule irreversible inhibitor of the histone lysine‐specific demethylase KDM1A (also known as LSD1), which corrects memory deficits and behavior alterations including aggression and social interaction deficits in preclinical models. Methods: Here, we report the results of REIMAGINE, a phase IIa, single‐center, open‐label, one‐arm basket trial that evaluated the safety and efficacy of vafidemstat on aggression in adult patients with borderline personality disorder (BPD), attention‐deficit/hyperactivity disorder (ADHD), and autistic spectrum disorder (ASD). Participants received 1.2 mg/day of vafidemstat for 8 weeks. Results: Vafidemstat was shown to be safe and well tolerated, and no drug‐related clinically significant adverse events were observed. Furthermore, all neuropsychiatric scales assessed showed notable efficacy signals, whether assessing agitation/aggression (Clinical Global Impression for Severity [CGI‐S] and Clinical Global Impression for Improvement [CGI‐I] and Neuropsychiatric Inventory [NPI] questionnaire for Agitation‐Aggression [NPI‐AA]), overall patient functioning (total NPI), or disease‐specific features (Attention‐Deficit/Hyperactivity Disorder Rating Scale [ADHD‐RS] and Borderline Personality Disorder Checklist [BPDCL]). Statistically significant improvements were observed in the aggregated data (all participants) and for each of the three disease groups independently. Changes were evident within the first 2 weeks of treatment. Conclusion: In summary, the REIMAGINE study supports that vafidemstat is safe, well tolerated, and causes a significant and consistent reduction in agitation/aggression and nonaggression features in BPD, ADHD, and ASD. These data support continuing the development of vafidemstat as a new treatment option for these psychiatric disorders. [ABSTRACT FROM AUTHOR]
Copyright of Psychiatry & Clinical Neurosciences is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
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  Data: REIMAGINE: A central nervous system basket trial showing safety and efficacy of vafidemstat on aggression in different psychiatric disorders.
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  Data: <searchLink fieldCode="AR" term="%22Ferrer%2C+Marc%22">Ferrer, Marc</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Richarte%2C+Vanesa%22">Richarte, Vanesa</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Gisbert%2C+Laura%22">Gisbert, Laura</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Xaus%2C+Jordi%22">Xaus, Jordi</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Gutierrez%2C+Sonia%22">Gutierrez, Sonia</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Arevalo%2C+Maria+Isabel%22">Arevalo, Maria Isabel</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Ropacki%2C+Michael%22">Ropacki, Michael</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Bullock%2C+Roger%22">Bullock, Roger</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Buesa%2C+Carlos%22">Buesa, Carlos</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Ramos‐Quiroga%2C+Josep+Antoni%22">Ramos‐Quiroga, Josep Antoni</searchLink> (AUTHOR)
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  Data: <searchLink fieldCode="JN" term="%22Psychiatry+%26+Clinical+Neurosciences%22">Psychiatry & Clinical Neurosciences</searchLink>. May2025, Vol. 79 Issue 5, p257-265. 9p.
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  Data: <searchLink fieldCode="DE" term="%22Aggression+%28Psychology%29%22">Aggression (Psychology)</searchLink><br /><searchLink fieldCode="DE" term="%22Borderline+personality+disorder%22">Borderline personality disorder</searchLink><br /><searchLink fieldCode="DE" term="%22Autism+spectrum+disorders%22">Autism spectrum disorders</searchLink><br /><searchLink fieldCode="DE" term="%22Mental+illness%22">Mental illness</searchLink><br /><searchLink fieldCode="DE" term="%22Histone+demethylases%22">Histone demethylases</searchLink><br /><searchLink fieldCode="DE" term="%22Patient+safety%22">Patient safety</searchLink><br /><searchLink fieldCode="DE" term="%22Attention-deficit+hyperactivity+disorder%22">Attention-deficit hyperactivity disorder</searchLink><br /><searchLink fieldCode="DE" term="%22Clinical+trials%22">Clinical trials</searchLink>
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  Label: Abstract
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  Data: Aim: Vafidemstat is a brain‐penetrant, orally bioavailable, small molecule irreversible inhibitor of the histone lysine‐specific demethylase KDM1A (also known as LSD1), which corrects memory deficits and behavior alterations including aggression and social interaction deficits in preclinical models. Methods: Here, we report the results of REIMAGINE, a phase IIa, single‐center, open‐label, one‐arm basket trial that evaluated the safety and efficacy of vafidemstat on aggression in adult patients with borderline personality disorder (BPD), attention‐deficit/hyperactivity disorder (ADHD), and autistic spectrum disorder (ASD). Participants received 1.2 mg/day of vafidemstat for 8 weeks. Results: Vafidemstat was shown to be safe and well tolerated, and no drug‐related clinically significant adverse events were observed. Furthermore, all neuropsychiatric scales assessed showed notable efficacy signals, whether assessing agitation/aggression (Clinical Global Impression for Severity [CGI‐S] and Clinical Global Impression for Improvement [CGI‐I] and Neuropsychiatric Inventory [NPI] questionnaire for Agitation‐Aggression [NPI‐AA]), overall patient functioning (total NPI), or disease‐specific features (Attention‐Deficit/Hyperactivity Disorder Rating Scale [ADHD‐RS] and Borderline Personality Disorder Checklist [BPDCL]). Statistically significant improvements were observed in the aggregated data (all participants) and for each of the three disease groups independently. Changes were evident within the first 2 weeks of treatment. Conclusion: In summary, the REIMAGINE study supports that vafidemstat is safe, well tolerated, and causes a significant and consistent reduction in agitation/aggression and nonaggression features in BPD, ADHD, and ASD. These data support continuing the development of vafidemstat as a new treatment option for these psychiatric disorders. [ABSTRACT FROM AUTHOR]
– Name: AbstractSuppliedCopyright
  Label:
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  Data: <i>Copyright of Psychiatry & Clinical Neurosciences is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
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        Value: 10.1111/pcn.13800
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      – Code: eng
        Text: English
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      Pagination:
        PageCount: 9
        StartPage: 257
    Subjects:
      – SubjectFull: Aggression (Psychology)
        Type: general
      – SubjectFull: Borderline personality disorder
        Type: general
      – SubjectFull: Autism spectrum disorders
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      – SubjectFull: Mental illness
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      – SubjectFull: Histone demethylases
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      – SubjectFull: Patient safety
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      – SubjectFull: Attention-deficit hyperactivity disorder
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      – SubjectFull: Clinical trials
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      – TitleFull: REIMAGINE: A central nervous system basket trial showing safety and efficacy of vafidemstat on aggression in different psychiatric disorders.
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              Text: May2025
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              Y: 2025
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