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Peer-reviewedCC BY-NC 4.0Alzheimer's & Dementia : Translational Research & Clinical Interventions

Efficacy of ORM‐12741 on agitation/aggression symptoms in participants with Alzheimer's disease

  • Juha O Rinne1,2
  • Jeffrey L Cummings3
  • Dagmar Breznoscakova4
  • Pasi Hakulinen5
  • Jutta Hänninen5
  • Pascal Goetghebeur6
  • David S Miller7
  • Juha Rouru5
7 affiliations
  1. 1Turku PET Centre University of Turku and Turku University Hospital Turku Finland
  2. 2CRST Oy (Clinical Research Services Turku) Turku Finland
  3. 3Chambers‐Grundy Center for Transformative Neuroscience Department of Brain Health Kirk Kerkorian School of Medicine University of Las Vegas Las Vegas Nevada USA
  4. 4Dept. of Social and Behavioural Medicine School of Medicine University of Pavol Jozef Šafárik Košice Slovakia
  5. 5R&D Orion Corporation Orion Pharma Espoo Finland
  6. 6Signant Heatlh London UK
  7. 7Signant Heatlh Pennsylvania USA
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Abstract

INTRODUCTION: ORM‐12741 is a potent and selective alpha‐2C adrenoceptor antagonist. The primary objective of this study was to evaluate the efficacy of ORM‐12741 in treating agitation/aggression symptoms in patients with Alzheimer's disease (AD).

METHODS: This was a phase II, double‐blind, placebo‐controlled study of 308 community‐dwelling participants with mild to moderate AD (Mini‐Mental State Examination [MMSE] scores 10 to 24) and Neuropsychiatric Inventory agitation/aggression scores of ≥4. Participants were randomized to 60 or 120 mg of ORM‐12741 or placebo twice daily for 12 weeks. Efficacy was assessed primarily with the sum of Neuropsychiatric Inventory Clinician Rating (NPI‐C) Agitation and Aggression domain scores. In addition, effects on cognition, psychotic, depressive, and overall neuropsychiatric symptoms were assessed.

RESULTS: No relevant treatment effects as compared to placebo group were detected on either the primary or secondary efficacy measures. ORM‐12741 was generally well tolerated.

DISCUSSION: The study does not support the efficacy of ORM‐12741 on agitation/aggression symptoms in patients with AD.

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Cite

BibTeXRIS
BibTeX
@article{rinne2026efficacy,
  title = {{Efficacy of ORM‐12741 on agitation/aggression symptoms in participants with Alzheimer's disease}},
  author = {Juha O Rinne and Jeffrey L Cummings and Dagmar Breznoscakova and Pasi Hakulinen and Jutta Hänninen and Pascal Goetghebeur and David S Miller and Juha Rouru},
  journal = {Alzheimer's \& Dementia : Translational Research \& Clinical Interventions},
  year = {2026},
  month = nov,
  doi = {10.1002/trc2.70332},
  url = {https://doi.org/10.1002/trc2.70332},
  note = {CC BY-NC 4.0},
}
RIS
TY  - JOUR
TI  - Efficacy of ORM‐12741 on agitation/aggression symptoms in participants with Alzheimer's disease
AU  - Juha O Rinne
AU  - Jeffrey L Cummings
AU  - Dagmar Breznoscakova
AU  - Pasi Hakulinen
AU  - Jutta Hänninen
AU  - Pascal Goetghebeur
AU  - David S Miller
AU  - Juha Rouru
PY  - 2026
DA  - 2026/11/02
JO  - Alzheimer's & Dementia : Translational Research & Clinical Interventions
DO  - 10.1002/trc2.70332
UR  - https://doi.org/10.1002/trc2.70332
AB  - INTRODUCTION: ORM‐12741 is a potent and selective alpha‐2C adrenoceptor antagonist. The primary objective of this study was to evaluate the efficacy of ORM‐12741 in treating agitation/aggression symptoms in patients with Alzheimer's disease (AD).  METHODS: This was a phase II, double‐blind, placebo‐controlled study of 308 community‐dwelling participants with mild to moderate AD (Mini‐Mental State Examination [MMSE] scores 10 to 24) and Neuropsychiatric Inventory agitation/aggression scores of ≥4. Participants were randomized to 60 or 120 mg of ORM‐12741 or placebo twice daily for 12 weeks. Efficacy was assessed primarily with the sum of Neuropsychiatric Inventory Clinician Rating (NPI‐C) Agitation and Aggression domain scores. In addition, effects on cognition, psychotic, depressive, and overall neuropsychiatric symptoms were assessed.  RESULTS: No relevant treatment effects as compared to placebo group were detected on either the primary or secondary efficacy measures. ORM‐12741 was generally well tolerated.  DISCUSSION: The study does not support the efficacy of ORM‐12741 on agitation/aggression symptoms in patients with AD.
SN  - 2352-8737
ER  -