Open-label, Multicenter, Phase III Extension Study of Idalopirdine as Adjunctive to Donepezil for the Treatment of Mild-moderate Alzheimer’s Disease

Manuscript Number: 

18-0595R1

Author(s): 
Alireza Atri, Clive G. Ballard, Neli Boneva, Jeffrey Cummings, Lutz Frölich, Marie A. Geist, José-Luis Molinuevo, Lars L. Raket, Pierre N. Tariot

Disclosures

Alireza Atri

  • Consulting Fees:
    Advisory Boards for: AbbVie Allergan Axovant Eisai Lundbeck Roche/Genentech Suven Synexus
    Lecture Fees:
    Lectured/participated in corporate-sponsored symposia by: Axovant Lundbeck Roche/Genentech
    Patents/Royalties
    Book Royalty: Oxford University Press (Dementia: Comprehensive Principles and Practice)
    Grants
    • Agency: 
      Abbvie (Grant to Past Institution for Contracted Research)
      Dates: 
      2017-18
    • Agency: 
      American College of Radiology (Grant to Past Institution for Contracted Research)
      Dates: 
      2016-18
    • Agency: 
      Biogen (Grant to Past Institution for Contracted Research)
      Dates: 
      2017-18
    • Agency: 
      Lilly (Grant to Past Institution for Contracted Research)
      Dates: 
      2017-18
    • Agency: 
      Lundbeck (Grant to Past Institution for Contracted Research)
      Dates: 
      2016-18
    • Agency: 
      Novartis (Grant to Current Institution for Contracted Research)
      Dates: 
      2018
    • Agency: 
      Avid (Grant to Past Institution for Contracted Research)
      Dates: 
      2016-18
    • Agency: 
      vTV (Grant to Past Institution for Contracted Research)
      Dates: 
      2017-18

Neli Boneva

  • Sponsors:
    Senior Medical Specialist Lundbeck

Jeffrey Cummings

  • Consulting Fees:
    Dr. Cummings has provided consultation to Acadia, Accera, Actinogen, Alkahest, Allergan, Alzheon, Avanir, Axsome, BiOasis Technologies, Biogen, Bracket, Denali, Diadem, EIP Pharma, Eisai, Forum, Genentech, Green Valley, Grifols, Hisun, Idorsia, Kyowa Kirin, Lilly, Lundbeck, MedAvante, Merck, Otsuka, Pain Therapeutics, Proclara, QR, Resverlogix, Roche, Samus, Sunovion, Suven, Takeda, Teva, Toyama, and United Neuroscience pharmaceutical and assessment companies.
    Equity:
    Dr. Cummings owns stock in ADAMAS, BioAsis, Prana, MedAvante, Neurokos, and QR Pharma.
    Lecture Fees:
    Lecture fees from Eisai, Axovant, Merck, and Grifols at Clinical Trials on Alzheimer's Disease and Alzheimer Association International Conference annual meetings 2018.
    Patents/Royalties
    Dr. Cummings owns the copyright to the Neuropsychiatric Inventory (NPI).
    Grants
    • Agency: 
      Avid Radiopharmaceuticals
      Dates: 
      2015-2018
    • Agency: 
      Teva Pharmaceuticals
      Dates: 
      2015-2018

Lutz Frölich

  • Consulting Fees:
    Consulting fees: Allergan, Eli Lilly, Avraham Pharmaceuticals, Axon Neuroscience, Axovant, Biogen, Boehringer Ingelheim, Functional Neuromodulation, Lundbeck, MerckSharpe & Dohme, Novartis, Pfizer, Pharnext, Roche, Schwabe Pharma
    Lecture Fees:
    Biogen, Eisai, Schwabe Pharma
    Grants
    • Agency: 
      Novartis
      Dates: 
      2014-2018

Marie A. Geist

  • Consulting Fees:
    I was an employee of H. Lundbeck A/S at the time
    Equity:
    stocks with h. Lundbeck A/S and Orphazyme A/S
    Sponsors:
    full time employee of H. Lundbeck A/S at the time of the study

José-Luis Molinuevo

  • Consulting Fees:
    Lundbeck, Biogen, J&J, Novartis, Axovant, Oryzon, Eisai, Green Valley, Genentech, Alector, Roche diagnostics, Raman
    Lecture Fees:
    Roche Diagnostics, Biogen, Novartis, MagQu

Lars L. Raket

  • Sponsors:
    Full-time employee of H. Lundbeck A/S

Pierre N. Tariot

  • Consulting Fees:
    Consulting and research support to Acadia, Abbott Laboratories, AbbVie, AC Immune, Auspex, Boehringer-Ingelheim, Brain Test Inc., California Pacific Medical Center, Syneos Health (Inc Research), Chase Pharmaceuticals, CME Inc., GliaCure, Insys Therapeutics, Pfizer, T3D
    Equity:
    Stock options in Adamas Pharmaceuticals
    Lecture Fees:
    Roche grant support API trial in Colombia Novartis grant support global API trial Amgen grant support global API trial AbbVie honorarium DSMB service AbbVie grant support phase 2 trial site Lilly honorarium protocol consultation Lilly grant support phase 3 trial site AstraZeneca honorarium protocol consultation Lundbeck honorarium consultation on trials AC Immune honorarium consultation on pipeline Merck grant support Phase 3 trial site Merck honorarium consultation on trials Takeda grant support Phase 3 trial site Boehringer-Ingelheim honorarium consultation on pipeline Syneos Health (Inc Research) honorarium consultation Other research support: National Institute on Aging (RF1 AG041705, 1UF1AG046150, R01 AG031581, R01 AG055444, P30 AG19610), Arizona Department of Health Services, Alzheimer’s Association, Banner Alzheimer’s Foundation, FBRI, GHR, Nomos Foundation, Flinn Foundation, Geoffrey Beene Foundation. Consulting fees: Acadia, Abbott Laboratories, AbbVie, AC Immune, Auspex, Boehringer-Ingelheim, Brain Test Inc., California Pacific Medical Center, Syneos Health (Inc Research), Chase Pharmaceuticals, CME Inc., GliaCure, Insys Therapeutics, Pfizer, T3D Consulting fees & research support: AstraZeneca, Avanir, Lilly, Lundbeck, Merck & Co., Roche, Takeda Research support only: Amgen, Avid, Biogen, Elan, Functional Neuromodulation (f(nm)), GE, Genentech, Novartis, Targacept
    Sponsors:
    Roche grant support API trial in Colombia Novartis grant support global API trial Amgen grant support global API trial AbbVie honorarium DSMB service AbbVie grant support phase 2 trial site Lilly honorarium protocol consultation Lilly grant support phase 3 trial site AstraZeneca honorarium protocol consultation Lundbeck honorarium consultation on trials AC Immune honorarium consultation on pipeline Merck grant support Phase 3 trial site Merck honorarium consultation on trials Takeda grant support Phase 3 trial site Boehringer-Ingelheim honorarium consultation on pipeline Syneos Health (Inc Research) honorarium consultation Other research support: National Institute on Aging (RF1 AG041705, 1UF1AG046150, R01 AG031581, R01 AG055444, P30 AG19610), Arizona Department of Health Services, Alzheimer’s Association, Banner Alzheimer’s Foundation, FBRI, GHR, Nomos Foundation, Flinn Foundation, Geoffrey Beene Foundation. Consulting fees: Acadia, Abbott Laboratories, AbbVie, AC Immune, Auspex, Boehringer-Ingelheim, Brain Test Inc., California Pacific Medical Center, Syneos Health (Inc Research), Chase Pharmaceuticals, CME Inc., GliaCure, Insys Therapeutics, Pfizer, T3D Consulting fees & research support: AstraZeneca, Avanir, Lilly, Lundbeck, Merck & Co., Roche, Takeda Research support only: Amgen, Avid, Biogen, Elan, Functional Neuromodulation (f(nm)), GE, Genentech, Novartis, Targacept
    Patents/Royalties
    Patents: I am listed as a contributor to a patent owned by the University of Rochester, “Biomarkers of Alzheimer’s Disease.”
    Grants
    • Agency: 
      Novartis; Roche; Amgen; AbbVie; Lilly, NIA, NIH, Merck & Takeda
      Dates: 
      2015-2018

Clive G. Ballard

  • Disclosure not yet completed