Potential of low dose leuco-methylthioninium bis(hydromethanesulphonate) (LMTM) monotherapy for treatment of mild Alzheimer’s disease: cohort analysis as modified primary outcome in a phase III clinical trial

Manuscript Number: 

17-0560R3

Author(s): 
Trevor Ahearn, Peter Bentham, Luc Bracoud, Charles S. Davis, Giovanni B. Frisoni, Serge Gauthier, Jiri H. Hardlund, Charles R. Harrington, Jianping Jia, Karin A. Kook, Ken Marek, Hans J. Moebius, Gernot Riedel, Björn O. Schelter, John Seibyl, Kohkan Shamsi, Roger T. Staff, John M.D. Storey, Vesna Vuksanovic, Gordon Wilcock, Claude M. Wischik, Damon J. Wischik

Disclosures

Trevor Ahearn

  • Nothing to Disclose

Peter Bentham

  • Sponsors:
    Paid consultant - clinical advice on study design. Responsible Officer for their Designated Body.

Luc Bracoud

  • Nothing to Disclose

Charles S. Davis

  • Consulting Fees:
    Consultant to TauRx

Giovanni B. Frisoni

  • Consulting Fees:
    Advisory Boards: Astra Zeneca, Elan, GE, Lilly, Lundbeck, Pfizer, Taurx.
    Grants
    • Agency: 
      Alzheimer's Association
      Dates: 
      2014-2018
    • Agency: 
      ASSM
      Dates: 
      03.11.15
    • Agency: 
      Alzheimer's Forum
      Dates: 
      03.11.15 | 04.04.17
    • Agency: 
      Lilly
      Dates: 
      03.11.15 | 04.04.17
    • Agency: 
      Nestlé
      Dates: 
      03.11.15
    • Agency: 
      Roche
      Dates: 
      03.11.15 | 04.04.17
    • Agency: 
      Vifor Pharma
      Dates: 
      03.11.15 | 09.12.15
    • Agency: 
      Merz
      Dates: 
      04.04.17
    • Agency: 
      Merz
      Dates: 
      04.04.17
    • Agency: 
      Siemens
      Dates: 
      09.12.15
    • Agency: 
      Piramal
      Dates: 
      2013-2017

Serge Gauthier

  • Consulting Fees:
    Scientific advisor to Kalgene, Lilly, TauRx
    Lecture Fees:
    Lecture fee from Schwabe for lecture in Spain November 2018
    Grants
    • Agency: 
      Washington University-DIAN-TU
      Dates: 
      2016-2019
    • Agency: 
      Lundbeck
      Dates: 
      2015-2018

Jiri H. Hardlund

  • Sponsors:
    Chief Medical Officer, VP Clinical Development

Charles R. Harrington

  • Equity:
    Equity held in privately listed TauRx Therapeutics Ltd
    Sponsors:
    Serve as Chief Scientific Officer for TauRx Therapeutics Ltd.
    Patents/Royalties
    I am an inventor on various pending and granted patents in the field of compounds (including LMTX and LMTM) for use in treating various conditions, including Alzheimer's disease.

Jianping Jia

  • Nothing to Disclose

Karin A. Kook

  • Consulting Fees:
    Paid consultant to TauRx and other pharmaceutical companies

Ken Marek

  • Consulting Fees:
    Pfizer, GE Healthcare, Lilly, BMS, Piramal, Biogen, Prothena, Roche, Neuropore, US Worldmeds, Neurophage, UCB, Oxford Biomedica, Lysosomal Therapetic, Inc, Neuroderm, Denali
    Equity:
    Ownership in invicro

Hans J. Moebius

  • Consulting Fees:
    I have received and continue to receive honoraria as a Scientifc Advisory Board member of RODIN Therapeutics Inc., Cambridge, MA.
    Equity:
    I am a non-voting stockholder of the former CHASE Pharmaceuticals Corp., Washington, DC, and of RODIN Therapeutics Inc., Cambridge, MA.

Gernot Riedel

  • Nothing to Disclose

Björn O. Schelter

  • Consulting Fees:
    Paid consultant of TauRx Therapeutics (Sponsor of the Study)
    Grants
    • Agency: 
      GTD/TauRx
      Dates: 
      2013-ongoing

John Seibyl

  • Consulting Fees:
    consultant to: Piramal Imaging, Roche
    Equity:
    Equity in Invicro,LLC

Kohkan Shamsi

  • Consulting Fees:
    we were a vendor for managing MRI and PET assessments in this clinical trial.
    Patents/Royalties
    the sponsor hired us as vendors to manage imaging assessments in this clinical trial

Roger T. Staff

  • Nothing to Disclose

John M.D. Storey

  • Equity:
    Equity in privately funded TauRx Therapeutics Ltd.
    Sponsors:
    Chief Technical Officer, TauRx Therapeutics Ltd.
    Patents/Royalties
    I am an inventor on various pending and granted patents in the field of compounds (including LMTX and LMTM) for use in treating various conditions, including Alzheimer's disease. My rights in these patents have been assigned to WisTa Laboratories Ltd, an affiliate of TauRx Therapeutics Ltd.

Vesna Vuksanovic

  • Nothing to Disclose

Gordon Wilcock

  • Consulting Fees:
    TauRx Advisory Board member - paid for attendance at board meetings
    Sponsors:
    Advisory Board member as mentioned above

Claude M. Wischik

  • Equity:
    I hold equity in and am co-founder of TauRx Therapeutics Ltd.
    Sponsors:
    Executive Chairman, TauRx Therapeutics Ltd.
    Patents/Royalties
    An inventor on various pending and granted patents in the field of compounds (including LMTM) for use in treating various conditions, including Alzheimer's disease. Rights assigned to WisTa Laboratories Ltd, an affilliate of TauRx Therapeutics Ltd.

Damon J. Wischik

  • Patents/Royalties
    WO08/155533, WO09/044127, WO09/060191, 2008.
    Grants
    • Agency: 
      Silicon Valley Community Foundation (for Cisco)
      Dates: 
      16 May 2017 to 16 May 2018