A Clinical Trial 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 (150)

• Banner Alzheimer?s Institute, Phoenix, Arizona · RECRUITING
• Sun Valley Research Center, Inc., Imperial, California · RECRUITING
• Healthy Brain Clinic, Long Beach, California · RECRUITING
• Oakland Clinical, Oakland, California · RECRUITING
• Riverside Clinical, Riverside, California · RECRUITING
• Cenexel California Neuroscience Research, LLC, Sherman Oaks, California · RECRUITING
• Yale University, New Haven, Connecticut · RECRUITING
• JEM Research LLC, Atlantis, Florida · RECRUITING
• K2 Medical Research-Winter Garden, Clermont, Florida · RECRUITING
• Visionary Investigators Network- Neurology Aventura, Miami, Florida · RECRUITING
• Charter Research - Winter Park/Orlando, Orlando, Florida · RECRUITING
• Conquest Research - Lake Nona, Orlando, Florida · RECRUITING
• Alzheimer's Research and Treatment Center, Stuart, Florida · RECRUITING
• CenExel iResearch, LLC, Decatur, Georgia · RECRUITING
• Center for Advanced Research & Education, Gainesville, Georgia · RECRUITING
• Great Lakes Clinical Trials Chicago d/b/a Flourish Research Andersonville, Chicago, Illinois · RECRUITING
• Adams Clinical Boston, Boston, Massachusetts · RECRUITING
• Adams Clinical Watertown, Watertown, Massachusetts · RECRUITING
• Quest Research Institute, Farmington Hills, Michigan · RECRUITING
• University of Nebraska Medical Center, Omaha, Nebraska · RECRUITING
• The Cognitive and Research Center of New Jersey, Springfield, New Jersey · RECRUITING
• IMA Clinical Research - Albuquerque, Albuquerque, New Mexico · RECRUITING
• AD-CARE, University of Rochester Medical Center, Rochester, New York · RECRUITING
• Summit Research Network Inc., Portland, Oregon · RECRUITING
• Flourish Research ? Philadelphia, Plymouth Meeting, Pennsylvania · RECRUITING
• Palmetto Clinical Trials, Summerville, South Carolina · RECRUITING
• Gadolin Research, LLC, Beaumont, Texas · RECRUITING
• Kerwin Medical Center, Dallas, Texas · RECRUITING
• Re:Cognition Health - Fort Worth, Fort Worth, Texas · RECRUITING
• Mt.Olympus Medical Research, Katy, Texas · RECRUITING
• El Faro Health and Therapeutics, Rio Grande City, Texas · RECRUITING
• Sana Research, LLC, Arlington, Virginia · RECRUITING
• Re:Cognition Health, Fairfax, Virginia · RECRUITING
• INECO Neurociencias Orono, Rosario, Santa Fe Province, Argentina · RECRUITING
• CIER, C. A. B. A., Argentina · RECRUITING
• Fundacion Scherbovsky, Mendoza, Argentina · RECRUITING
• Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia · RECRUITING
• Southern Neurology, Kogarah, New South Wales, Australia · RECRUITING
• KaRa Institute of Neurological Diseases, Macquarie Park, New South Wales, Australia · RECRUITING
• Flinders Medical Centre, Bedford Park, South Australia, Australia · RECRUITING
• Queen Elizabeth Hospital, Woodville, South Australia, Australia · RECRUITING
• Box Hill Hospital, Box Hill, Victoria, Australia · RECRUITING
• Austin Health, Heidelberg, Victoria, Australia · RECRUITING
• Alfred Hospital, Melbourne, Victoria, Australia · RECRUITING
• Alzheimer?s Research Australia, Nedlands, Western Australia, Australia · RECRUITING
• L2 Ip Instituto de Pesquisas Clinicas Ltda ME, Brasília, Federal District, Brazil · RECRUITING
• Instituto de Neurologia de Curitiba, Curitiba, Paraná, Brazil · RECRUITING
• Clinica Clinilive ltda, Maringá, Paraná, Brazil · RECRUITING
• Instituto do Cerebro do Rio Grande do Sul, Porto Alegre, Rio Grande do Sul, Brazil · RECRUITING
• Clinica Neurologica, Joinville, Santa Catarina, Brazil · RECRUITING
• CEMEC - Centro Multidisciplinar de Estudos Clínicos, São Bernardo do Campo, São Paulo, Brazil · RECRUITING
• Okanagan Clinical Trials, Kelowna, British Columbia, Canada · RECRUITING
• Centricity Research, Halifax, Nova Scotia, Canada · RECRUITING
• Parkwood Institute Main Building, London, Ontario, Canada · RECRUITING
• The Ottawa Memory Clinic, Ottawa, Ontario, Canada · RECRUITING
• Kawartha Centre - Redefining Healthy Aging, Peterborough, Ontario, Canada · RECRUITING
• Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada · RECRUITING
• St. Michael's Hospital, Toronto, Ontario, Canada · RECRUITING
• Genge Partners Inc., Montreal, Quebec, Canada · RECRUITING
• Aalborg Universitetshospital, Aalborg, Denmark · RECRUITING
• Aarhus Universitetshospital Skejby, Aarhus N, Denmark · RECRUITING
• Rigshospitalet, Hukommelsesklinikken, København Ø, Denmark · RECRUITING
• CHU Amiens Hopital Sud, Amiens Cedex1, France · ACTIVE_NOT_RECRUITING
• Centre Hospitalier Universitaire de Bordeaux Hopital Pellegrin, Bordeaux, France · ACTIVE_NOT_RECRUITING
• Groupement Hospitalier Est - Hôpital Neurologique, Bron, France · ACTIVE_NOT_RECRUITING
• CHU Dupruytren - Limoges, Limoges, France · ACTIVE_NOT_RECRUITING
• Hopital Gui de Chauliac, Montpellier, France · ACTIVE_NOT_RECRUITING
• Ch Pitie Salpetriere, Paris, France · ACTIVE_NOT_RECRUITING
• CHU de Rouen Hopital, Rouen, France · WITHDRAWN
• Hop Guillaume Et Rene Laennec, Saint-Herblain, France · ACTIVE_NOT_RECRUITING
• Hôpital Robertsau, Strasbourg, France · ACTIVE_NOT_RECRUITING
• Universitaetsklinikum Erlangen, Erlangen, Bavaria, Germany · RECRUITING
• Ambulates Gesundheitszentrum der Charité GmbH, Berlin, Germany · RECRUITING
• ECRC Experimental and Clinical Research Center, Charité Campus Berlin Buch, Memory Clinic, Berlin, Germany · RECRUITING
• German Center for Neurodegenerative Diseases (DZNE), Bonn, Germany · RECRUITING
• Universitätsklinikum Köln, Cologne, Germany · RECRUITING
• Medizinische Fakultät Carl Gustav Carus, Dresden, Germany · RECRUITING
• Universitätsklinikum des Saarlandes Klinik f. Psychiatrie und Psychotherapie, Homburg/Saar, Germany · RECRUITING
• Universitätsklinikum Jena, Klinik für Neurologie, Jena, Germany · RECRUITING
• Universität Leipzig, Leipzig, Germany · RECRUITING
• Otto-von-Guericke-Universität Magdeburg, Magdeburg, Germany · RECRUITING
• Zentralinstitut für Seelische Gesundheit Abt.Gerontopsychiatrie, Mannheim, Germany · RECRUITING
• LMU Klinikum, Neurologische Klinik und Poliklinik, München, Germany · RECRUITING
• Ludwig-Maximilians-Univ., München, Germany · WITHDRAWN
• Universitätsklinikum Münster, Münster, Germany · RECRUITING
• Neuropraxis München Süd, Unterhaching, Germany · RECRUITING
• A. O. U. Federico II, Naples, Campania, Italy · RECRUITING
• Nuovo Ospedale Civile S. Agostino-Estense, Modena, Emilia-Romagna, Italy · RECRUITING
• Policlinico Universitario Agostino Gemelli, Rome, Lazio, Italy · RECRUITING
• Ospedale Isola Tiberina - Gemelli Isola, Rome, Lazio, Italy · RECRUITING
• AO di Perugia - Ospedale S. Maria della Misericordia, Perugia, Umbria, Italy · ACTIVE_NOT_RECRUITING
• Brain Attack Center Ota Memorial Hospital, Hiroshima, Japan · RECRUITING
• National Hospital Organization Hiroshima-Nishi Medical Center, Hiroshima, Japan · RECRUITING
• Kobe University Hospital, Hyōgo, Japan · RECRUITING
• Kagawa University Hospital, Kagawa, Japan · RECRUITING
• Kochi Medical School Hospital, Kochi, Japan · RECRUITING
• Okayama City Hospital, Okayama, Japan · RECRUITING
• Rijikai Medical Corporation Katayama Medical Clinic, Okayama, Japan · RECRUITING
• Kotobuki Social Medical Corporation Tominaga Clinic, Osaka, Japan · RECRUITING
• The University of Tokyo Hospital, Tokyo, Japan · RECRUITING
• Higashi-Shinjuku Clinic, Tokyo, Japan · RECRUITING
• Brain Research Center Den Bosch, 's-Hertogenbosch, Netherlands · ACTIVE_NOT_RECRUITING
• Brain Research Center B.V, Amsterdam, Netherlands · ACTIVE_NOT_RECRUITING
• Brain Research Center Zwolle, Zwolle, Netherlands · ACTIVE_NOT_RECRUITING
• O?rodek Badawczo-Naukowo-Dydaktyczny Chorób Ot?piennych w ?cinawie, ?cinawa, Poland · ACTIVE_NOT_RECRUITING
• ProNeuro Centrum Medyczne, ?ory, Poland · ACTIVE_NOT_RECRUITING
• Uniwersytet Medyczny w Lodzi, ?ód?, Poland · ACTIVE_NOT_RECRUITING
• Syberka-ClinHouse Sp. z o.o., B?dzin, Poland · RECRUITING
• Podlaskie Centrum Psychogeriatrii, Bia?ystok, Poland · ACTIVE_NOT_RECRUITING
• Uniwersyteckie Centrum Kliniczne, Gdansk, Poland · ACTIVE_NOT_RECRUITING
• Szpital Uniwersytecki w Krakowie, Krakow, Poland · ACTIVE_NOT_RECRUITING
• Clinical Research Center Sp. z o.o. MEDIC-R Spó?ka Komandytowa, Późna, Poland · ACTIVE_NOT_RECRUITING
• Centrum Medyczne "MEDYK", Rzeszów, Poland · ACTIVE_NOT_RECRUITING
• Senior Sp. Z O.O. Poradnia Psychogeriatryczna, Sopot, Poland · ACTIVE_NOT_RECRUITING
• NeuroProtect, Warsaw, Poland · ACTIVE_NOT_RECRUITING
• Pusan National University Hospital, Busan, South Korea · ACTIVE_NOT_RECRUITING
• Chonnam National University Hospital, Gwangju, South Korea · ACTIVE_NOT_RECRUITING
• Ajou University Medical Center, Gyeonggi-do, South Korea · ACTIVE_NOT_RECRUITING
• St. Vincent's Hospital, Gyeonggi-do, South Korea · ACTIVE_NOT_RECRUITING
• Gachon University Gil Medical Center, Incheon, South Korea · ACTIVE_NOT_RECRUITING
• Inha University Hospital, Incheon, South Korea · ACTIVE_NOT_RECRUITING
• Seoul National University Bundang Hospital, Seongnam-si, South Korea · ACTIVE_NOT_RECRUITING
• Hanyang University Seoul Hospital, Seoul, South Korea · ACTIVE_NOT_RECRUITING
• Asan Medical Center, Seoul, South Korea · ACTIVE_NOT_RECRUITING
• Samsung Medical Center, Seoul, South Korea · ACTIVE_NOT_RECRUITING
• Ewha Womans University Hospital (Seoul), Seoul, South Korea · ACTIVE_NOT_RECRUITING
• Korea University Guro Hospital, Seoul, South Korea · ACTIVE_NOT_RECRUITING
• Hospital Universitario Marques de Valdecilla, Santander, Cantabria, Spain · RECRUITING
• Fundación ACE, Barcelona, Spain · RECRUITING
• Hospital de la Santa Creu i Sant Pau, Barcelona, Spain · RECRUITING
• Hospital Ramon y Cajal, Madrid, Spain · RECRUITING
• Hospital Universitario 12 de Octubre, Madrid, Spain · RECRUITING
• Hospital Victoria Eugenia, Seville, Spain · RECRUITING
• Hospital Virgen del Rocío, Seville, Spain · RECRUITING
• Hospital Universitario la Fe, Valencia, Spain · RECRUITING
• Inselspital Bern Medizin Neurologie, Bern, Switzerland · ACTIVE_NOT_RECRUITING
• Hôpitaux universitaires de Genève, Geneva, Switzerland · ACTIVE_NOT_RECRUITING
• CHUV Lausanne Méd.Neurologie, Lausanne, Switzerland · ACTIVE_NOT_RECRUITING
• Ospedale Regionale di Lugano - Civico, Lugano, Switzerland · ACTIVE_NOT_RECRUITING
• ReMind UK, Bath, United Kingdom · RECRUITING
• Re:Cognition Health Birmingham, Birmingham, United Kingdom · RECRUITING
• Scottish Brain Sciences, Edinburgh, United Kingdom · RECRUITING
• Queen Elizabeth University Hospital Glasgow, Glasgow, United Kingdom · RECRUITING
• St George?s Hospital, London, United Kingdom · RECRUITING
• RE:Cognition Health, London, United Kingdom · RECRUITING
• UCL Institute of Neurology, London, United Kingdom · RECRUITING
• Manchester Mental Health and Social Care Trust, Manchester, United Kingdom · RECRUITING
• Warneford Hospital, Oxford, United Kingdom · RECRUITING
• Lancashire and South Cumbria NHS Foundation Trust, Preston, United Kingdom · RECRUITING
• Southampton University Hospitals NHS Trust, Southampton, United Kingdom · RECRUITING