Pharmacodynamic effects of semorinemab on plasma and CSF biomarkers of Alzheimer's disease pathophysiology (2024)

Competing Interest Statement

All authors are full-time employees and own stock in F. Hoffmann-La Roche Ltd. Edmond Teng is listed as a co-inventor on the patent for semorinemab.

Clinical Trial

NCT03289143, NCT03828747

Funding Statement

The study was funded by F. Hoffmann-La Roche Ltd and Genentech.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

All of Ethics committees/IRB listed below gave ethical approval for the Tauriel (NCT03289143) study. [1] NeuroCentrix / Bellberry Human Research Ethics Committees [2] Royal Melbourne Hospital / Melbourne Health Human Research Ethics Committee [3] Royal Melbourne Hospital / Alfred Hospital Ethic Committee [4] Southern Neurology / Bellberry Human Research Ethics Committees [5] Universitair Ziekenhuis Brussel / Ethische Commissie Onderzoek UZ-KU Leuven [6] UZ Leuven / Ethische Commissie Onderzoek UZ-KU Leuven [7] AZ Groeninge / Ethische Commissie Onderzoek UZ-KU Leuven [8] Clinique de la Memoire de l'Outaoua / WCG Clinical [9] Toronto Sunnybrook Hospital / Sunnybrook Health Sciences REB [10] Toronto Memory Program (Neurolog / WCG Clinical [11] Bruyere Continuing Care / Bruyere Continuing Care REB [12] JBN Medical Diagnostic Services Inc. / WCG Clinical [13] Toronto Western Hospital / University Health Network Research Ethics Board [14] CCBR - Vejle - DK / Videnskabsetiske Komite for Region Nordjylland [15] CCBR - AAlborg - DK / Videnskabsetiske Komite for Region Nordjylland [16] Centre pour Personnes AAges / Comite de Protection des Personnes Sud-ouest et Outre-Mer IV [17] CHU Rennes - Pontchaillou / CPP Nord-Ouest III [18] CHU Strasbourg - Hopital Hautepierr / Comite de Protection des Personnes Sud-ouest et Outre-Mer IV [19] Hopital de la Timone / CPP Nord-Ouest III [20] Groupe Hospitalier Pitie-Salpetriere / CPP Nord-Ouest III [21] Hopital des Chapennes / CPP Nord-Ouest III [22] CHU de Lyon - Hopital Neurologique / CPP Nord-Ouest III [23] CHU Lille - Hopital Roger Salengro / Comite de Protection des Personnes Sud-ouest et Outre-Mer IV [24] Klinikum rechts der Isar der TU Muenchen / Ethikkommission der Fakultat fur Medizin der TU Munchen [25] Klinische Forschung Hannover-Mitte / Ethikkommission der Fakultat fur Medizin der TU Munchen [26] Universitatsklinikum Tuebingen / Ethikkommission der Fakultat fur Medizin der TU Munchen [27] Charite - Campus Berlin Buch, Experi / Ethikkommission der Fakultat fur Medizin der TU Munchen [28] Universitatsklinikum Ulm / Ethikkommission der Fakultat fur Medizin der TU Munchen [29] Azienda Ospedaliera Universitaria Po / Comitato etico dell'Azienda Policlinico Umberto I [30] Ospedale San Giovanni Calabita Fate / Comitato Etico Lazio 1 [31] I.R.C.C.S. Neuromed-Istituto Neurolo / Comitato Etico dell'I.R.C.C.S. Neuromed-Istituto Neurologico Mediterraneo [32] Azienda Ospedaliera Card. G. Panico / Comitato Etico della AUSL LE di Lecce [33] Jeroen Bosch Ziekenhuis / Stichting Beoordeling Ethiek Biomedisch Onderzoek [34] Brain Research Center / Stichting Beoordeling Ethiek Biomedisch Onderzoek [35] Centrum Medyczne NeuroProtect / Komisja Bioetyczna przy Dolnoslaskiej Izbie Lekarskiej [36] Podlaskie Centrum Psychogeriatrii / Komisja Bioetyczna przy Dolnoslaskiej Izbie Lekarskiej [37] NZOZ NEURO-KARD, Ilkowski i Par / Komisja Bioetyczna przy Dolnoslaskiej Izbie Lekarskiej [38] Neuro-Care Gabriela Klodowska / Komisja Bioetyczna przy Dolnoslaskiej Izbie Lekarskiej [39] Pratia MCM Krakow / Komisja Bioetyczna przy Dolnoslaskiej Izbie Lekarskiej [40] PALLMED Sp. z o.o. / Komisja Bioetyczna przy Dolnoslaskiej Izbie Lekarskiej [41] Centrum Medyczne AMED Warszawa / Komisja Bioetyczna przy Dolnoslaskiej Izbie Lekarskiej [42] Osrodek Badan Klinicznych EUROME / Komisja Bioetyczna przy Dolnoslaskiej Izbie Lekarskiej [43] NZOZ Wroclawskie Centrum Alzheim / Komisja Bioetyczna przy Dolnoslaskiej Izbie Lekarskiej [44] Novo-Med Zielinski i wspolnicy Sp. j. / Komisja Bioetyczna przy Dolnoslaskiej Izbie Lekarskiej [45] Hospital Perpetuo Socorro / La Fe Department de Salut [46] Hospital Universitario Reina Sofia / La Fe Department de Salut [47] Hospital Universitari i Politecnic La F / La Fe Department de Salut [48] Hospital de la Santa Creu i Sant Pau / La Fe Department de Salut [49] Fundacio ACE / La Fe Department de Salut [50] Hospital Universitario Dr. Peset / La Fe Department de Salut [51] Hospital Universitario Mutua de Terr / La Fe Department de Salut [52] Policlinica Gipuzkoa / La Fe Department de Salut [53] Hospital de Cantoblanco / La Fe Department de Salut [54] Clinica Universidad de Navarra / La Fe Department de Salut [55] Hospital Clinic de Barcelona / La Fe Department de Salut [56] Hospital Universitario Virgen Macare / La Fe Department de Salut [57] Sahlgrenska Universitetssjukhuset, M / Regionala etikprovningnamnden i Stockholm [58] Skanes Universitetssjukhus, Malmo / Regionala etikprovningnamnden i Stockholm [59] Re:Cognition Health Ltd (London) / London - Chelsea Research Ethics Committee [60] The National Hospital for Neurology / London - Chelsea Research Ethics Committee [61] Miami Jewish Health System, Inc / WCG Clinical [62] Southern Illinois University Neurolog / Springfield Committee for Research Involving Human Subjects [63] Neuropsychiatric Research Center of / WCG Clinical [64] Brain Matters Research / WCG Clinical [65] Empire Neurology, PC / Copernicus Group IRB [66] Alexian Brothers Medical Center - Ne / WCG Clinical [67] University of Alabama at Birmingham / WCG Clinical [68] JEM Research Institute / WCG Clinical [69] Synexus Clinical Research US, Inc. - O / Copernicus Group IRB [70] Albany Medical College / WCG Clinical [71] Perlmutter Cancer Center NYU Lango / Columbia University Medical Center IRB [72] Collier Neurologic Specialists, LLC / WCG Clinical [73] Emory University / WCG Clinical [74] Summit Research Network (Oregon) / WCG Clinical [75] Brigham and Women's Hospital / WCG Clinical [76] Premiere Research Institute / Copernicus Group IRB [77] KI Health Partners, LLC / Copernicus Group IRB [78] Bradenton Research Center, Inc. / Copernicus Group IRB [79] Bradenton Research Center, Inc. / WCG Clinical [80] The Memory Clinic / Copernicus Group IRB [81] Alzheimers Disease Center / Copernicus Group IRB [82] Collaborative Neuroscience Network / WCG Clinical [83] Pharmacology Research Institute / WCG Clinical [84] University of Rochester / WCG Clinical [85] Center for Memory and Aging / HealthPartners Institute Institutional Review Board [86] Molecular Neuroimaging / WCG Clinical [87] University of California - Irvine / University of California - Irvine IRB [88] Butler Hospital / Copernicus Group IRB [89] Stanford Hospital and Clinics / Stanford University - Human Subjects IRB [90] Rush University Medical Center-Chic / Rush University Medical Center - Office of Research Affairs [91] Advanced Memory Research Institut / WCG Clinical [92] AMR New Orleans, Formerly New Or / WCG Clinical [93] Neurology Clinic, PC / Copernicus Group IRB [94] Rhode Island Mood & Memory Resea / WCG Clinical [95] Pacific Research Network, Inc / WCG Clinical [96] Georgetown University Medical Cent / Georgetown University Hospital IRB [97] Alzheimer's Research and Treatment / WCG Clinical [98] Abington Neurological Associates / WCG Clinical All of Ethics committees/IRB listed below gave ethical approval for the Lauriet (NCT03828747) study. [1] Brain Matters Research / WCG Clinical [2] Synexus Clinical Research US, Inc. / WCG Clinical [3] Alexian Brothers Medical Center - Neuroscience Research Institute / WCG Clinical [4] Alzheimer's Research and Treatment Center / WCG Clinical [5] JEM Research Institute / WCG Clinical [6] Abington Neurological Associates, LTD / WCG Clinical [7] Neuropsychiatric Research Center of Southwest Florida / WCG Clinical [8] Alzheimers Disease Center / WCG Clinical [9] CHU Rennes - Pontchaillou / CPP Nord-Ouest III [10] Hopital de la Timone / CPP Nord-Ouest III [11] Groupe Hospitalier Pitie-Salpetriere / CPP Nord-Ouest III [12] Hopital Neurologique Bron / CPP Nord-Ouest III [13] Centrum Medyczne NeuroProtect / Komisja Bioetyczna przy Dolnoslaskiej Izbie Lekarskiej [14] Podlaskie Centrum Psychogeriatrii / Komisja Bioetyczna przy Dolnoslaskiej Izbie Lekarskiej [15] NZOZ NEURO-KARD, Ilkowski i Partnerzy Sp. Partn. Lek. / Komisja Bioetyczna przy Dolnoslaskiej Izbie Lekarskiej [16] Osrodek Badan Klinicznych EUROMEDIS / Komisja Bioetyczna przy Dolnoslaskiej Izbie Lekarskiej [17] NZOZ Wroclawskie Centrum Alzheimerowskie / Komisja Bioetyczna przy Dolnoslaskiej Izbie Lekarskiej [18] NZOZ NOVO-MED / Komisja Bioetyczna przy Dolnoslaskiej Izbie Lekarskiej [19] KI Health Partners, LLC / WCG Clinical [20] Miami Jewish Health System, Inc / WCG Clinical [21] Southern Illinois University Neurology Clinic / Springfield Committee for Research Involving Human Subjects [22] Neurology Clinic, PC / WCG Clinical [23] Empire Neurology, PC / WCG Clinical [24] Collier Neurologic Specialists, LLC / WCG Clinical [25] Summit Headlands LLC / WCG Clinical [26] Brigham and Women's Hospital / WCG Clinical [27] Alphab Global Research / WCG Clinical [28] CenExel Collaborative Neuroscience Research / WCG Clinical [29] Pharmacology Research Institute / WCG Clinical [30] University of Rochester - PARENT / WCG Clinical [31] Center for Memory and Aging / HealthPartners Institute Institutional Review Board [32] Stanford Hospital and Clinics / Stanford University - Human Subjects IRB [33] CenExel Advanced Memory Research Institute of NJ / WCG Clinical [34] Pacific Research Network, Inc / WCG Clinical [35] Bradenton Research Center, Inc. / WCG Clinical [36] The Memory Clinic / WCG Clinical [37] Molecular Neuroimaging / WCG Clinical [38] Butler Hospital / WCG Clinical [39] Rush University Medical Center-Chicago / Rush University Medical Center - Office of Research Affairs [40] Rhode Island Mood & Memory Research Institute / WCG Clinical [41] AMR Knoxville, Formerly New Orleans Center for Clinical Research - Knoxville, an AMR company / WCG Clinical [42] Hopital des Chapennes / CPP Nord-Ouest III [43] Hospital Universitari i Politecnic La Fe / La Fe Department de Salut [44] Hospital de la Santa Creu i Sant Pau / La Fe Department de Salut [45] Fundacio ACE / La Fe Department de Salut [46] Hospital Universitario Dr. Peset / La Fe Department de Salut [47] Hospital Clinic de Barcelona / La Fe Department de Salut [48] Hospital Universitario Mutua de Terrasa / La Fe Department de Salut [49] Centrum Medyczne AMED Warszawa Zoliborz / Komisja Bioetyczna przy Dolnoslaskiej Izbie Lekarskiej

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes