A Study of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease

Summary

The purpose of this study is to assess the efficacy and safety of trontinemab in participants with early symptomatic Alzheimer's disease (AD) (mild cognitive impairment \[MCI\] to mild dementia due to AD).

Interventions

• Trontinemab · DRUG

  Participants will receive IV trontinemab.

• Placebo · OTHER

  Participants will receive IV placebo.

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

Inclusion Criteria:

* Willingness and ability to complete all aspects of the study (including MRI, clinical genotyping, and PET imaging or CSF as applicable) for the duration of the study. The participant should be capable of completing assessments either alone or with the help of the study partner
* Adequate visual and auditory acuity, in the investigator's judgment, sufficient to perform the neuropsychological testing (eyewear and hearing aids are permitted)
* Evidence of AD pathological process, as confirmed on amyloid PET scan. A CSF tau181/Aβ42 ratio may be used as an alternative option if amyloid PET is not available
* Probable AD dementia or MCI due to AD, also known as an Alzheimer's clinical syndrome clinical Stage 3 or Stage 4
* Screening MMSE score ≥ 22 and CDR-GS of 0.5 or 1.0
* Participant- and/or Informant-reported history of cognitive decline with gradual onset and progression over the last 1 year before screening
* A Repeatable Battery for the Assessment of Neuropsychological Status Delayed Memory Index (RBANS DMI) score of 85 or order
* Availability of a "study partner" as defined by the protocol

Exclusion Criteria:

* Any evidence of a condition other than AD that may affect cognition
* History or presence of clinically significant cerebrovascular disease
* History of severe, clinically significant (persistent neurologic deficit or structural brain damage) central nervous system (CNS) trauma
* History or presence of clinically significant intracranial mass
* MRI evidence of significant cerebral abnormalities or inability to tolerate MRI procedures or contraindication to MRI
* Any other medical conditions (e.g., cardiovascular, hepatic, renal disease) which are not stable and adequately controlled or which in the opinion of the investigator could affect the participant's safety in the study or interfere with the study assessments
* History of malignancy with the following exceptions: if considered to be cured; malignancies with a negligible risk of metastasis or death

Sites (143)

• University of Alabama at Birmingham, Birmingham, Alabama · RECRUITING
• Banner Sun Health Research Institute, Sun City, Arizona · RECRUITING
• Irvine Center for Clinical Research, Irvine, California · RECRUITING
• Inglewood Clinicals, Los Angeles, California · RECRUITING
• UCSF - Memory and Aging Center, San Francisco, California · RECRUITING
• Syrentis Clinical Research, Santa Ana, California · RECRUITING
• K2 Medical Research - The Villages, Lady Lake, Florida · RECRUITING
• K2 Medical Research, LLC, Maitland, Florida · RECRUITING
• Renstar Medical Research, Ocala, Florida · RECRUITING
• Axiom Brain Health LLC, Tampa, Florida · RECRUITING
• Charter Research - Lady Lake/The Villages, The Villages, Florida · RECRUITING
• Alzheimer?s Research and Treatment Center, Wellington, Florida · RECRUITING
• Conquest Research, LLC, Winter Park, Florida · RECRUITING
• Alzheimer's Research and Treatment Center - Columbus, Columbus, Georgia · RECRUITING
• Accel Research Sites-NeuroStudies, Decatur, Georgia · RECRUITING
• Hawaii Pacific Neuroscience, Honolulu, Hawaii · RECRUITING
• RE:Cognition (Chicago), Chicago, Illinois · RECRUITING
• Tandem Clinical Research, LLC, Marrero, Louisiana · RECRUITING
• Brigham and Womens Hospital, Boston, Massachusetts · RECRUITING
• Boston Center for Memory, Newton, Massachusetts · RECRUITING
• Washington University School of Medicine, St Louis, Missouri · RECRUITING
• The Cognitive and Research Center of New Jersey, Ridgewood, New Jersey · RECRUITING
• Basil Clinical, Laurelton, New York · RECRUITING
• Weill Cornell Medical College, New York, New York · RECRUITING
• Adams Clinical Harlem, New York, New York · RECRUITING
• Adams Clinical Bronx, The Bronx, New York · RECRUITING
• Triad Clinical Trials, Greensboro, North Carolina · RECRUITING
• Ohio State University, Columbus, Ohio · RECRUITING
• Butler Hospital, Providence, Rhode Island · RECRUITING
• Genesis Neuroscience Clinic, Knoxville, Tennessee · RECRUITING
• K2 Medical Research - Nashville, Nashville, Tennessee · RECRUITING
• Kerwin Research Center, LLC, Dallas, Texas · RECRUITING
• South Texas Research Institute - Edinburg, Edinburg, Texas · RECRUITING
• Re:Cognition Health - Houston, Houston, Texas · RECRUITING
• National Clinical Research Inc.-Richmond, Richmond, Virginia · RECRUITING
• Hospital Italiano, CABA, Argentina · RECRUITING
• Sanatorio del Sur S.A., San Miguel de Tucumán, Argentina · RECRUITING
• Hospital das Clinicas - UFMG, Belo Horizonte, Minas Gerais, Brazil · RECRUITING
• Hospital Moinhos de Vento, Porto Alegre, Rio Grande do Sul, Brazil · RECRUITING
• Centro de Pesquisas Clinicas - CPCLIN, São Paulo, São Paulo, Brazil · RECRUITING
• Richmond Clinical Trials, Richmond, British Columbia, Canada · RECRUITING
• Baycrest Academy for Research and Education, North YORK, Ontario, Canada · RECRUITING
• Toronto Memory Program, Toronto, Ontario, Canada · RECRUITING
• Centricity East York, Toronto, Ontario, Canada · RECRUITING
• Toronto Western Hospital, Toronto, Ontario, Canada · RECRUITING
• Clinique Memoire de Montreal, Montreal, Quebec, Canada · RECRUITING
• Alpha Recherche Clinique, Québec, Canada · RECRUITING
• The Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu, China · RECRUITING
• Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, Shanghai Municipality, China · RECRUITING
• Peking University First Hospital, Beijing, China · RECRUITING
• Beijing Friendship Hospital Affiliated of Capital University of Medical Science, Beijing, China · RECRUITING
• Beijing Tiantan Hospital,Capital Medical University, Beijing, China · RECRUITING
• Peking University Sixth Hospital, Beijing, China · RECRUITING
• The First Hospital of Jilin University, Changchun, China · RECRUITING
• West China Hospital - Sichuan University, Chengdu, China · RECRUITING
• The First Affiliated Hospital, Chongqing Medical University, Chongqing, China · RECRUITING
• Fujian Medical University Union Hospital, Fuzhou, China · RECRUITING
• Guangdong General Hospital, Guangzhou, China · RECRUITING
• The second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China · RECRUITING
• Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, China · RECRUITING
• The First Affiliated Hospital of Anhui Medical University, Hefei, China · RECRUITING
• Anhui Provincial Hospital, Hefei, China · ACTIVE_NOT_RECRUITING
• Zhongda Hospital Affiliated to Southeast University, Nanjing, China · ACTIVE_NOT_RECRUITING
• Nanjing Brain Hospital, Nanjing, China · RECRUITING
• Nanjing First Hospital, Nanjing, China · ACTIVE_NOT_RECRUITING
• Ruijin Hospital Shanghai Jiaotong University School of Medicine, Shanghai, China · RECRUITING
• Huashan Hospital, Fudan University, Shanghai, China · RECRUITING
• Shanghai First People's Hospital, Shanghai, China · RECRUITING
• Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China · RECRUITING
• Shanghai Pudong Hospital, Shanghai, China · RECRUITING
• The Second Affiliated Hospital of Soochow University, Suzhou, China · RECRUITING
• Tianjin Medical University General Hospital, Tianjin, China · RECRUITING
• Hôpital Broca, Le Kremlin Bicétre Cedex, France · ACTIVE_NOT_RECRUITING
• Hopital B Roger Salengro, Lille, France · ACTIVE_NOT_RECRUITING
• Hôpital de la Timone, Marseille, France · ACTIVE_NOT_RECRUITING
• Hopital Lariboisiere, Paris, France · ACTIVE_NOT_RECRUITING
• CHU Rennes - Hopital Pontchaillou, Rennes, France · ACTIVE_NOT_RECRUITING
• Gerontopole, Toulouse, France · ACTIVE_NOT_RECRUITING
• CHRU - Hôpital Bretonneau, Tours, France · ACTIVE_NOT_RECRUITING
• Hôpital de Brabois, Vandœuvre-lès-Nancy, France · ACTIVE_NOT_RECRUITING
• Hopital des Charpennes, Villeurbanne, France · ACTIVE_NOT_RECRUITING
• Uniklinik RWTH Aachen, Aachen, Germany · ACTIVE_NOT_RECRUITING
• Zentrum für klinische Forschung Dr. med. Irma Schöll, Bad Homburg, Germany · ACTIVE_NOT_RECRUITING
• Klinikum Bayreuth Standort Hohe Warte Klinik fur Neurologie, Bayreuth, Germany · ACTIVE_NOT_RECRUITING
• St. Josef-Hospital, Klinik für Neurologie, Bochum, Germany · ACTIVE_NOT_RECRUITING
• Gesundheit Nord, Klinikum Bremen-Ost, Bremen, Germany · ACTIVE_NOT_RECRUITING
• NeuroCentrum Odenwald, Erbach/Odenwald, Germany · ACTIVE_NOT_RECRUITING
• Universitätsklinikum Freiburg, Klinik für Neurologie und Neurophysiologie, Freiburg im Breisgau, Germany · ACTIVE_NOT_RECRUITING
• MVZ Rheumatologie und Autoimummedizin Hamburg GmbH, Hamburg, Germany · ACTIVE_NOT_RECRUITING
• Neurology UKSH Campus Kiel, Kiel, Germany · ACTIVE_NOT_RECRUITING
• Klinikum rechts der Isar der TU München, München, Germany · ACTIVE_NOT_RECRUITING
• Gemeinschaftspraxis Dr. Wolfram von Pannwitz, MBA & Dr. med. Marie Perle Brinckmann, Steglitz, Germany · ACTIVE_NOT_RECRUITING
• Krankenhaus der Barmherzigen Brüder Trier, Trier, Germany · ACTIVE_NOT_RECRUITING
• Universitätsklinikum Ulm, Ulm, Germany · ACTIVE_NOT_RECRUITING
• Fondazione Santa Lucia IRCCS, Rome, Lazio, Italy · RECRUITING
• Umberto I Policlinico di Roma-Università di Roma La Sapienza, Rome, Lazio, Italy · RECRUITING
• Azienda Ospedaliero Universitaria San Martino, Genoa, Liguria, Italy · RECRUITING
• Asst Degli Spedali Civili Di Brescia, Brescia, Lombardy, Italy · RECRUITING
• IRCCS Ospedale San Raffaele, Milan, Lombardy, Italy · RECRUITING
• Kyoto University Hospital, Kyoto, Japan · RECRUITING
• National Hospital Organization Utano National Hospital, Kyoto, Japan · RECRUITING
• Mishuku Hospital, Meguro-Ku, Japan · RECRUITING
• Mie University Hospital, Mie, Japan · RECRUITING
• Memory Clinic Ochanomizu, Tokyo, Japan · RECRUITING
• Keio University Hospital, Tokyo, Japan · RECRUITING
• Tokyo Metropolitan Institute for Geriatrics and Gerontology, Tokyo, Japan · RECRUITING
• National Center of Neurology and Psychiatry, Tokyo, Japan · RECRUITING
• Federation of National Public Service Personnel Mutual Aid Associations Tachikawa Hospital, Tokyo, Japan · RECRUITING
• P-One Clinic, Tokyo, Japan · RECRUITING
• Yamagata Tokusyukai Hospital, Yamagata, Japan · RECRUITING
• Centrum Medyczne Neuromed Sp. z.o.o., Bydgoszcz, Poland · ACTIVE_NOT_RECRUITING
• NEURO-CARE Sp. z o.o. Sp. Komandytowa, Katowice, Poland · ACTIVE_NOT_RECRUITING
• Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii K, Krakow, Poland · ACTIVE_NOT_RECRUITING
• Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak., Lublin, Poland · ACTIVE_NOT_RECRUITING
• Nmedis sp. z o.o., Rzeszów, Poland · RECRUITING
• ETG Neuroscience Sp. z o.o., Warsaw, Poland · ACTIVE_NOT_RECRUITING
• Centrum Leczenia Zaburzen Pamieci, Warsaw, Poland · ACTIVE_NOT_RECRUITING
• NZOZ WCA, Wroc?aw, Poland · ACTIVE_NOT_RECRUITING
• SPSK nr 1, Zabrze, Poland · ACTIVE_NOT_RECRUITING
• Hospital General De Catalunya, Sant Cugat del Vallès, Barcelona, Spain · RECRUITING
• Hospital Mutua De Terrasa, Terrassa, Barcelona, Spain · RECRUITING
• Policlínica Guipuzcoa, Donostia / San Sebastian, Guipuzcoa, Spain · RECRUITING
• Hospital Universitario de Santa Maria, Lleida, Lerida, Spain · RECRUITING
• Hospital Quiron de Madrid, Pozuelo de Alarcón, Madrid, Spain · RECRUITING
• Hospital Vall d'Hebron, Barcelona, Spain · RECRUITING
• Hospital Universitario Reina Sofia, Córdoba, Spain · RECRUITING
• Hospital Universitario de la Princesa, Madrid, Spain · RECRUITING
• Hospital Universitario Dr. Peset, Valencia, Spain · RECRUITING
• Kaohsiung Medical University Hospital, Kaohsiung City, Taiwan · RECRUITING
• Taipei Medical University ?Shuang Ho Hospital, New Taipei City, Taiwan · RECRUITING
• China Medical University Hospital, North Dist., Taiwan · RECRUITING
• Taichung Veterans General Hospital, Taichung, Taiwan · RECRUITING
• National Taiwan University Hospital, Taipei, Taiwan · RECRUITING
• Taipei Veterans General Hospital, Taipei, Taiwan · RECRUITING
• Chang Gung Medical Foundation Linkou Branch, Taoyuan City, Taiwan · RECRUITING
• Lynfield Mount hospital, Bradford, United Kingdom · RECRUITING
• Recognition Health Bristol, Bristol, United Kingdom · RECRUITING
• Surrey and Borders NHS Foundation Trust, Chertsey, United Kingdom · RECRUITING
• Department of Old Age Psychiatry Kings College, London, United Kingdom · RECRUITING
• RE:Cognition Health, London, United Kingdom · RECRUITING
• Charing Cross Hospital, London, United Kingdom · RECRUITING
• Campus for Ageing & Vitality, Newcastle, United Kingdom · RECRUITING
• Tees,Esk and Wear Valleys NHS Foundation Trust, York, United Kingdom · RECRUITING