A Phase II study of fornix deep brain stimulation in mild Alzheimer's disease

Manuscript Number: 

16-0017R3

Author(s): 
William S. Anderson, Wael F. Asaad, Gordon Baltuch, Anna Burke, M. Mallar Chakravarty, Kristen E. Drake, Kelly D. Foote, Lisa Fosdick, Peter Giacobbe, Jeannie-Marie Leoutsakos, Andres M. Lozano, Constantine G. Lyketsos, Christopher H. Lyman, MaryPat McAndrews, Cynthia Munro, Esther S. Oh, Michael S. Okun, Jo Cara Pendergrass, Francisco A. Ponce, Paul B. Rosenberg, Marwan N. Sabbagh, Stephen Salloway, Gwenn S. Smith, David F. Tang-Wai, Steven D. Targum, David Wolk

Disclosures

William S. Anderson

  • Consulting Fees:
    I serve as a compensated consultant for Longeviti, LLC. This is a company that makes custom fit cranioplasty implants.

Wael F. Asaad

  • Patents/Royalties
    Patent Pending: "Improved Intracranial Fixation Device" for DBS electrodes and other intracranial probes.

Gordon Baltuch

  • Nothing to Disclose

Anna Burke

  • Consulting Fees:
    Consulting- Eli Lilly
    Grants
    • Agency: 
      Banner Alzheimer's Institute has received research support from FNM for the ADVance Study.
      Dates: 
      2013- 2016

M. Mallar Chakravarty

  • Nothing to Disclose

Kristen E. Drake

  • Equity:
    Stock options held in Functional Neuromodulation.
    Sponsors:
    Employed by Functional Neuromodulation (as Senior Clinical Manager) for duration of the study.

Kelly D. Foote

  • Grants
    • Agency: 
      Medtronic
      Dates: 
      2007-present
    • Agency: 
      ANS/St. Jude
      Dates: 
      2008-2014
    • Agency: 
      Functional Neuromodulation
      Dates: 
      2012-2015
    • Agency: 
      Neuropace
      Dates: 
      2010-2013
    • Agency: 
      Boston Scientific
      Dates: 
      2013-present

Lisa Fosdick

  • Equity:
    I have stock options as part of my employment.
    Sponsors:
    Senior Operations Manager and also provided data management and analytic help

Peter Giacobbe

  • Lecture Fees:
    Speakers Bureau/Honoraria: BMS, Lundbeck

Jeannie-Marie Leoutsakos

  • Nothing to Disclose

Andres M. Lozano

  • Consulting Fees:
    Medtronic St Jude Boston Scientific Aleva Functional Neuromodulation
    Equity:
    Functional Neuromodulation
    Lecture Fees:
    Occasional Lecture fees for Medtronic, St Jude. Boston Scientific, Aleva
    Patents/Royalties
    Patents in the field of deep brain stimulation

Constantine G. Lyketsos

  • Consulting Fees:
    Limited consulting or advising for the following over almost two decades: Astra-Zeneca, Glaxo-Smith Kline, Eisai, Novartis, Forest, Supernus, Adlyfe, Takeda, Wyeth, Lundbeck, Merz, Lilly, Pfizer, Genentech, Elan, NFL Players Association, NFL Benefits Office, Avanir, Zinfandel, BMS, Abvie, Janssen, Orion, Otsuka, Astellas
    Grants
    • Agency: 
      fNMI
      Dates: 
      2010-2016

Christopher H. Lyman

  • Nothing to Disclose

MaryPat McAndrews

  • Nothing to Disclose

Cynthia Munro

  • Nothing to Disclose

Esther S. Oh

  • Nothing to Disclose

Michael S. Okun

  • Consulting Fees:
    Dr. Okun serves as a consultant for the National Parkinson Foundation, and has received research grants from NIH, NPF, the Michael J. Fox Foundation, the Parkinson Alliance, Smallwood Foundation, the Bachmann-Strauss Foundation, the Tourette Syndrome Association, and the UF Foundation.  Dr. Okun’s DBS research is supported by: R01 NR014852 and R01NS096008. Dr. Okun has previously received honoraria, but in the past >60 months has received no support from industry.  Dr. Okun has received royalties for publications with Demos, Manson, Amazon, Smashwords, Books4Patients, and Cambridge (movement disorders books).  Dr. Okun is an associate editor for New England Journal of Medicine Journal Watch Neurology. Dr. Okun has participated in CME and educational activities on movement disorders (in the last 36) months sponsored by PeerView, Prime, QuantiaMD, WebMD, Medicus, MedNet, Henry Stewart, and by Vanderbilt University. The institution and not Dr. Okun receives grants from Medtronic, Abbvie, Allergan, and ANS/St. Jude, and the PI has no financial interest in these grants. Dr. Okun has participated as a site PI and/or co-I for several NIH, foundation, and industry sponsored trials over the years but has not received honoraria.

Jo Cara Pendergrass

  • Nothing to Disclose

Francisco A. Ponce

  • Consulting Fees:
    Consultant for Medtronic

Paul B. Rosenberg

  • Consulting Fees:
    < $5000 annually from Abbvie, Merck, INSYS, GLG

Marwan N. Sabbagh

  • Consulting Fees:
    consulting- Axovant Biogen FORUM Pharmaceuticals Fujirebio Diagnostics Humana Lilly Pharmaceuticals Sanofi vTv Therapeutics
    Equity:
    Stock ownership- Brain Health, Inc , Muses Labs, Inc, Versanum Inc.
    Patents/Royalties
    Royalties- Tenspeed/Random House
    Grants
    • Agency: 
      AstraZeneca
    • Agency: 
      Avid Pharmaceuticals
    • Agency: 
      Axovant
    • Agency: 
      Genetech
    • Agency: 
      Lilly Pharmaceuticals
    • Agency: 
      Merck & Co
    • Agency: 
      Pfizer
    • Agency: 
      Piramal Imaging
    • Agency: 
      Roche Diagnostics Corporation
    • Agency: 
      vTv Therapeutics

Stephen Salloway

  • Consulting Fees:
    Biogen, Merck, Roche, Genentech, Lilly
    Grants
    • Agency: 
      Functional Neuromodulation
      Dates: 
      2013-2016
    • Agency: 
      Novartis
      Dates: 
      2016
    • Agency: 
      Biogen
      Dates: 
      2013-2016
    • Agency: 
      Merck
      Dates: 
      2013-2016
    • Agency: 
      Roche
      Dates: 
      2012-2016
    • Agency: 
      Avid
      Dates: 
      2013-2016
    • Agency: 
      Lilly
      Dates: 
      2014-2016
    • Agency: 
      Genentech
      Dates: 
      2013-2016

Gwenn S. Smith

  • Grants
    • Agency: 
      Functional Neuromodulation, Incorporated
      Dates: 
      2012-2015

David F. Tang-Wai

  • Nothing to Disclose

Steven D. Targum

  • Consulting Fees:
    Forum Pharmaceuticals (advisory)
    Equity:
    stock in Methylation Sciences Inc., Prana Biotechnology Ltd., Functional Neuromodulation, Bracket G:obal

David Wolk

  • Grants
    • Agency: 
      Merck
      Dates: 
      6/1/14 to present
    • Agency: 
      Avid Radiopharmaceuticals
      Dates: 
      6/1/14 to present
    • Agency: 
      Biogen
      Dates: 
      11/17/15 to present