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. 2023 Apr 5;12(3):727–749. doi: 10.1007/s40120-023-00467-8

Table 4.

Agents in phase 2 clinical trials for dementia with Lewy bodies

Agent CADRO Mechanism of action Therapeutic purpose Status Registry source Registry number Start date End datea
CT1812 Synaptic plasticity/neuroprotection σ-2 receptor modulator DMT Recruiting CT.gov and ICTPR NCT05225415 June 2022 April 2024
Fosgonimeton (ATH-1017) Growth factors and hormones Activates signaling via the hepatocyte growth factor (HGF) DMT Recruiting CT.gov and ICTPR NCT04831281 January 2022 November 2023
Ondansetron Neurotransmitter receptors Selective antagonist of serotonin 5-HT3 receptors Symptomatic Recruiting CT.gov and ICTPR NCT04167813 October 2021 January 2025
CST-103, CST-107 Neurotransmitter receptors

CST-103: β-2 adrenoceptor agonist

CST-107: β blocker with minimal brain penetration

Symptomatic Active, not recruiting CT.gov, ICTPR, EudraCT

NCT04739423

2020–006,067-28

June 2021 August 2022
Ambroxol Proteostasis/proteinopathies Increases lysosomal fraction and the enzymatic activity of glucocerebrosidase DMT Recruiting CT.gov and EUdraCT

NCT04588285

2019–002,855-41

May 2021 December 2023
Irsenontrine Synaptic plasticity/neuroprotection Active and selective phosphodiesterase 9 (PDE9) inhibitor Symptomatic Completed CT.gov and ICTPR NCT04764669 February 2021 January 2022
Zonisamide Neurotransmitter receptors Sulfonamide, antiseizure. Inhibitor of sodium and T-type calcium channels. Potentiates dopaminergic and serotonergic neurotransmission Symptomatic Not recruiting ICTPR jRCTs041190126 February 2021 Missing data
Zonisamide Neurotransmitter receptors Sulfonamide, antiseizure. Inhibitor of sodium and T-type calcium channels. Potentiates dopaminergic and serotonergic neurotransmission Symptomatic Not recruiting ICTPR jRCTs051200054 September 2020 Missing data
NYX-458 Neurotransmitter receptors NMDAR receptor modulator that enhances synaptic plasticity Symptomatic Recruiting CT.gov and ICTPR NCT04148391 November 2019 December 2022
Neflamapimod Synaptic plasticity/neuroprotection ATP competitive inhibitor of p38α kinase DMT Completed CT.gov and EUdraCT

NCT04001517

2019–001,566-15

September 2019 June 2020
Nilotinib Proteostasis/proteinopathies Tyrosine kinase inhibitor DMT Recruiting CT.gov and ICTPR NCT04002674 July 2019 April 2023
HTL0018318 Neurotransmitter receptors Selective muscarinic M1 receptor partial agonist Symptomatic Withdrawn CT.gov and ICTPR

NCT03592862

JapicCTI-183989

July 2019 September 2019
Bosutinib Proteostasis/proteinopathies Tyrosine kinase inhibitor DMT Completed CT.gov and ICTPR NCT03888222 April 2019 April 2021
Irsenontrine Synaptic plasticity/neuroprotection Active and selective phosphodiesterase 9 (PDE9) inhibitor Symptomatic Completed CT.gov, ICTPR, EudraCT

NCT03467152

JapicCTI-183932

2017–003,728-64

May 2018 April 2020
LY3154207 (Mevidalen) Neurotransmitter receptors Positive allosteric modulator of the dopamine receptor D1 Symptomatic Completed CT.gov and ICTPR NCT03305809 November 2017 July 2020
Intepirdine Neurotransmitter receptors Selective 5-HT6 receptor antagonist Symptomatic Completed CT.gov and ICTPR NCT02910102 October 2016 November 2017
Vodobatinib (K0706) Proteostasis/proteinopathies Tyrosine kinase inhibitor DMT Recruiting CT.gov and ICTPR NCT03996460 September 2016 October 2023
Galantamine Neurotransmitter receptors Acetylcholinesterase inhibitor Symptomatic Pending ICTPR UMIN000022860 September 2016 Missing data
Nelotanserin Neurotransmitter receptors Selective antagonist of the 5-HT2A serotonin receptor Symptomatic Completed CT.gov and ICTPR NCT02708186 March 2016 May 2018
Intepirdine Neurotransmitter receptors Selective 5-HT6 receptor antagonist Symptomatic Completed CT.gov, ICTPR, EudraCT

NCT02669433

2015–005,495-19

January 2016 December 2017
Nelotanserin Neurotransmitter receptors Selective antagonist of the 5-HT2A serotonin receptor Symptomatic Completed CT.gov and ICTPR NCT02640729 December 2015 November 2017
Zonisamide Neurotransmitter receptors Sulfonamide, antiseizure. Inhibitor of sodium and T-type calcium channels. Potentiates dopaminergic and serotonergic neurotransmission Symptomatic Completed ICTPR JapicCTI-122040 March 2013 April 2014
Zonisamide Neurotransmitter receptors Sulfonamide, antiseizure. Inhibitor of sodium and T-type calcium channels. Potentiates dopaminergic and serotonergic neurotransmission Symptomatic Completed ICTPR UMIN000010631 September 2012 May 2013
Ferulic acid Oxidative stress Suppresses free radicals, chronic inflammation and aggregation of amyloid-β protein in the brain Symptomatic Completed ICTPR UMIN000003683 June 2010 May 2013
Armodafinil Unknown target Unknown/Eugeroics: stimulants that provide long-lasting mental arousal Symptomatic Withdrawn CT.gov and ICTPR NCT01256905 January 2011 August 2011
Youkukansan Multi-target Prevents neurotoxicity induced by amyloid-associated oxidative stress. Improves glutamate uptake and inhibits glutamate-induced neuronal death. Partial agonistic effect on serotonin 5-HT1A receptors Symptomatic Missing data ICTPR UMIN000001832 April 2009 Missing data
Ramelteon Neurotransmitter receptors Agonist of MT1 and MT2 melatonin receptors Symptomatic Withdrawn CT.gov and ICTPR NCT00907595 May 2009 July 2010
Ramelteon Neurotransmitter receptors Agonist of MT1 and MT2 melatonin receptors Symptomatic Terminated CT.gov NCT00745030 June 2008 December 2009
Donepezil Neurotransmitter receptors Acetylcholinesterase inhibitor Symptomatic Completed CT.gov and ICTPR NCT00543855 November 2007 February 2010
Memantine Neurotransmitter receptors Antagonist of NMDA glutamate receptors Symptomatic Completed EudraCT and ICTPR

2005–004,109-27

ISRCTN89624516

March 2006 September 2008
Memantine Neurotransmitter receptors Antagonist of NMDA glutamate receptors Symptomatic Completed CT.gov and ICTPR NCT00630500 February 2006 March 2009

aEnd date: actual end date or study completion date

DMT disease-modifying treatment