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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trontinemab | Experimental | Participants will receive intravenous (IV) trontinemab. |
|
| Placebo | Placebo Comparator | Participants will receive IV placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trontinemab | Drug | Participants will receive IV trontinemab |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to Week 72 in Clinical Dementia Rating, Sum of Boxes (CDR-SB) | Baseline - Week 72 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline through Week 72 in Alzheimer's Disease Assessment Scale-Cognition 13 (ADAS-Cog-13) | Baseline - Week 72 | |
| Change from baseline through Week 72 in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) total score and instrumental score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Reference Study ID Number: WN45447 https://forpatients.roche.com/ No attachments to email below. | Contact | 888-662-6728 | global-roche-genentech-trials@gene.com | |
| Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner Alzheimer?s Institute | Recruiting | Phoenix | Arizona | 85006 | United States | |
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| Label | URL |
|---|---|
| Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours. | View source |
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For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
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| Placebo | Other | Participants will receive IV placebo |
|
| Baseline - Week 72 |
| Change from baseline through Week 72 in Integrated Alzheimer's Disease Rating Scale (iADRS) | Baseline - Week 72 |
| Change from baseline through Week 72 in Mini-Mental State Examination (MMSE) | Baseline - Week 72 |
| Change from baseline in CDR-SB | Baseline up to but excluding Week 72 |
| Time to increase in Clinical Dementia Rating, Global Score (CDR-GS) | Baseline - Week 72 |
| Percentage of participants with adverse events (AEs) | Baseline - Week 72 |
| Percentage of participants with amyloid-related imaging abnormalities (ARIA) magnetic resonance imaging (MRI) findings | Baseline - Week 72 |
| Percentage of participants with infusion-related reactions (IRR) | Baseline - Week 72 |
| Percentage of participants with anti-drug antibodies (ADAs) to trontinemab | Baseline - Week 72 |
| Change from baseline through Week 72 in brain amyloid load as measured by amyloid positron emission tomography (PET) scan | Baseline - Week 72 |
| Change from baseline to Week 72 in brain tau load as measured by tau PET scan in a subset of participants | Baseline - Week 72 |
| Change from baseline through Week 72 in cerebrospinal fluid (CSF) biomarkers of disease p-tau181, neurogranin, Aβ42 in a subset of participants | Baseline - Week 72 |
| Change from baseline through Week 72 in blood biomarkers p-tau217, glial fibrillar acidic protein (GFAP) | Baseline - Week 72 |
| Sun Valley Research Center, Inc. |
| Recruiting |
| Imperial |
| California |
| 92251 |
| United States |
| Healthy Brain Clinic | Recruiting | Long Beach | California | 90804 | United States |
| Oakland Clinical | Recruiting | Oakland | California | 94609 | United States |
| Riverside Clinical | Recruiting | Riverside | California | 92506 | United States |
| Cenexel California Neuroscience Research, LLC | Recruiting | Sherman Oaks | California | 91403 | United States |
| Yale University | Recruiting | New Haven | Connecticut | 06510 | United States |
| JEM Research LLC | Recruiting | Atlantis | Florida | 33462 | United States |
| K2 Medical Research-Winter Garden | Recruiting | Clermont | Florida | 34711 | United States |
| Visionary Investigators Network- Neurology Aventura | Recruiting | Miami | Florida | 33133 | United States |
| Charter Research - Winter Park/Orlando | Recruiting | Orlando | Florida | 32803 | United States |
| Conquest Research - Lake Nona | Recruiting | Orlando | Florida | 32832 | United States |
| Alzheimer's Research and Treatment Center | Recruiting | Stuart | Florida | 34996 | United States |
| CenExel iResearch, LLC | Recruiting | Decatur | Georgia | 30030 | United States |
| Center for Advanced Research & Education | Recruiting | Gainesville | Georgia | 30501 | United States |
| Great Lakes Clinical Trials Chicago d/b/a Flourish Research Andersonville | Recruiting | Chicago | Illinois | 60640 | United States |
| Adams Clinical Boston | Recruiting | Boston | Massachusetts | 02116 | United States |
| Adams Clinical Watertown | Recruiting | Watertown | Massachusetts | 02472 | United States |
| Quest Research Institute | Recruiting | Farmington Hills | Michigan | 48334 | United States |
| University of Nebraska Medical Center | Recruiting | Omaha | Nebraska | 68198-8440 | United States |
| The Cognitive and Research Center of New Jersey | Recruiting | Springfield | New Jersey | 07081 | United States |
| IMA Clinical Research - Albuquerque | Recruiting | Albuquerque | New Mexico | 87109 | United States |
| AD-CARE, University of Rochester Medical Center | Recruiting | Rochester | New York | 14620 | United States |
| Summit Research Network Inc. | Recruiting | Portland | Oregon | 97210 | United States |
| Flourish Research ? Philadelphia | Recruiting | Plymouth Meeting | Pennsylvania | 19462 | United States |
| Palmetto Clinical Trials | Recruiting | Summerville | South Carolina | 29485 | United States |
| Gadolin Research, LLC | Recruiting | Beaumont | Texas | 77702 | United States |
| Kerwin Medical Center | Recruiting | Dallas | Texas | 75216 | United States |
| Re:Cognition Health - Fort Worth | Recruiting | Fort Worth | Texas | 76104 | United States |
| Mt.Olympus Medical Research | Recruiting | Katy | Texas | 77450 | United States |
| El Faro Health and Therapeutics | Recruiting | Rio Grande City | Texas | 78582 | United States |
| Sana Research, LLC | Recruiting | Arlington | Virginia | 22205 | United States |
| Re:Cognition Health | Recruiting | Fairfax | Virginia | 22031 | United States |
| INECO Neurociencias Orono | Recruiting | Rosario | Santa Fe Province | S2000DTC | Argentina |
| CIER | Recruiting | C. A. B. A. | C1055AAF | Argentina |
| Fundacion Scherbovsky | Recruiting | Mendoza | 5500 | Argentina |
| Royal Prince Alfred Hospital | Recruiting | Camperdown | New South Wales | 2050 | Australia |
| Southern Neurology | Recruiting | Kogarah | New South Wales | 2217 | Australia |
| KaRa Institute of Neurological Diseases | Recruiting | Macquarie Park | New South Wales | 2113 | Australia |
| Flinders Medical Centre | Recruiting | Bedford Park | South Australia | 5042 | Australia |
| Queen Elizabeth Hospital | Recruiting | Woodville | South Australia | 5011 | Australia |
| Box Hill Hospital | Recruiting | Box Hill | Victoria | 3128 | Australia |
| Austin Health | Recruiting | Heidelberg | Victoria | 3084 | Australia |
| Alfred Hospital | Recruiting | Melbourne | Victoria | 3004 | Australia |
| Alzheimer?s Research Australia | Recruiting | Nedlands | Western Australia | 6009 | Australia |
| L2 Ip Instituto de Pesquisas Clinicas Ltda ME | Recruiting | Brasília | Federal District | 70200-730 | Brazil |
| Instituto de Neurologia de Curitiba | Recruiting | Curitiba | Paraná | 81210-310 | Brazil |
| Clinica Clinilive ltda | Recruiting | Maringá | Paraná | 87013-250 | Brazil |
| Instituto do Cerebro do Rio Grande do Sul | Recruiting | Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| Clinica Neurologica | Recruiting | Joinville | Santa Catarina | 89202-190 | Brazil |
| CEMEC - Centro Multidisciplinar de Estudos Clínicos | Recruiting | São Bernardo do Campo | São Paulo | 09715-090 | Brazil |
| Okanagan Clinical Trials | Recruiting | Kelowna | British Columbia | V1Y 1Z9 | Canada |
| Centricity Research | Recruiting | Halifax | Nova Scotia | B3S 1N2 | Canada |
| Parkwood Institute Main Building | Recruiting | London | Ontario | N6C0A7 | Canada |
| The Ottawa Memory Clinic | Recruiting | Ottawa | Ontario | K1Z 1G3 | Canada |
| Kawartha Centre - Redefining Healthy Aging | Recruiting | Peterborough | Ontario | K9H 2P4 | Canada |
| Sunnybrook Health Sciences Centre | Recruiting | Toronto | Ontario | M4N 3M5 | Canada |
| St. Michael's Hospital | Recruiting | Toronto | Ontario | M5B 1W8 | Canada |
| Genge Partners Inc. | Recruiting | Montreal | Quebec | H4A 3T2 | Canada |
| Aalborg Universitetshospital | Recruiting | Aalborg | 9000 | Denmark |
| Aarhus Universitetshospital Skejby | Recruiting | Aarhus N | 8200 | Denmark |
| Rigshospitalet, Hukommelsesklinikken | Recruiting | København Ø | 2100 | Denmark |
| CHU Amiens Hopital Sud | Active, not recruiting | Amiens Cedex1 | 80054 | France |
| Centre Hospitalier Universitaire de Bordeaux Hopital Pellegrin | Active, not recruiting | Bordeaux | 33076 | France |
| Groupement Hospitalier Est - Hôpital Neurologique | Active, not recruiting | Bron | 69677 | France |
| CHU Dupruytren - Limoges | Active, not recruiting | Limoges | 87042 | France |
| Hopital Gui de Chauliac | Active, not recruiting | Montpellier | 34295 | France |
| Ch Pitie Salpetriere | Active, not recruiting | Paris | 75651 | France |
| CHU de Rouen Hopital | Withdrawn | Rouen | 76031 | France |
| Hop Guillaume Et Rene Laennec | Active, not recruiting | Saint-Herblain | 44800 | France |
| Hôpital Robertsau | Active, not recruiting | Strasbourg | 67000 | France |
| Universitaetsklinikum Erlangen | Recruiting | Erlangen | Bavaria | 91054 | Germany |
| Ambulates Gesundheitszentrum der Charité GmbH | Recruiting | Berlin | 12200 | Germany |
| ECRC Experimental and Clinical Research Center, Charité Campus Berlin Buch, Memory Clinic | Recruiting | Berlin | 13125 | Germany |
| German Center for Neurodegenerative Diseases (DZNE) | Recruiting | Bonn | 53127 | Germany |
| Universitätsklinikum Köln | Recruiting | Cologne | 50937 | Germany |
| Medizinische Fakultät Carl Gustav Carus | Recruiting | Dresden | 01307 | Germany |
| Universitätsklinikum des Saarlandes Klinik f. Psychiatrie und Psychotherapie | Recruiting | Homburg/Saar | 66421 | Germany |
| Universitätsklinikum Jena, Klinik für Neurologie | Recruiting | Jena | 07747 | Germany |
| Universität Leipzig | Recruiting | Leipzig | 04103 | Germany |
| Otto-von-Guericke-Universität Magdeburg | Recruiting | Magdeburg | 39120 | Germany |
| Zentralinstitut für Seelische Gesundheit Abt.Gerontopsychiatrie | Recruiting | Mannheim | 68159 | Germany |
| LMU Klinikum, Neurologische Klinik und Poliklinik | Recruiting | München | 81377 | Germany |
| Ludwig-Maximilians-Univ. | Recruiting | München | 81377 | Germany |
| Universitätsklinikum Münster | Recruiting | Münster | 48149 | Germany |
| Neuropraxis München Süd | Recruiting | Unterhaching | 82008 | Germany |
| A. O. U. Federico II | Recruiting | Naples | Campania | 80131 | Italy |
| Nuovo Ospedale Civile S. Agostino-Estense | Recruiting | Modena | Emilia-Romagna | 41126 | Italy |
| Policlinico Universitario Agostino Gemelli | Recruiting | Rome | Lazio | 00168 | Italy |
| Ospedale Isola Tiberina - Gemelli Isola | Recruiting | Rome | Lazio | 00186 | Italy |
| AO di Perugia - Ospedale S. Maria della Misericordia | Recruiting | Perugia | Umbria | 06156 | Italy |
| Brain Attack Center Ota Memorial Hospital | Recruiting | Hiroshima | 720-0825 | Japan |
| National Hospital Organization Hiroshima-Nishi Medical Center | Recruiting | Hiroshima | 739-0696 | Japan |
| Kobe University Hospital | Recruiting | Hyōgo | 650-0017 | Japan |
| Kagawa University Hospital | Recruiting | Kagawa | 761-0793 | Japan |
| Kochi Medical School Hospital | Recruiting | Kochi | 783-8505 | Japan |
| Okayama City Hospital | Recruiting | Okayama | 700-8557 | Japan |
| Rijikai Medical Corporation Katayama Medical Clinic | Recruiting | Okayama | 710-0813 | Japan |
| Kotobuki Social Medical Corporation Tominaga Clinic | Recruiting | Osaka | 556-0015 | Japan |
| The University of Tokyo Hospital | Recruiting | Tokyo | 113-8655 | Japan |
| Higashi-Shinjuku Clinic | Recruiting | Tokyo | 169-0072 | Japan |
| Brain Research Center Den Bosch | Active, not recruiting | 's-Hertogenbosch | 5223 LA | Netherlands |
| Brain Research Center B.V | Active, not recruiting | Amsterdam | 1081 GN | Netherlands |
| Brain Research Center Zwolle | Active, not recruiting | Zwolle | 8025AZ | Netherlands |
| O?rodek Badawczo-Naukowo-Dydaktyczny Chorób Ot?piennych w ?cinawie | Recruiting | ?cinawa | 59-330 | Poland |
| ProNeuro Centrum Medyczne | Recruiting | ?ory | 44-240 | Poland |
| Uniwersytet Medyczny w Lodzi | Recruiting | ?ód? | 92-216 | Poland |
| Syberka-ClinHouse Sp. z o.o. | Recruiting | B?dzin | 42-500 | Poland |
| Podlaskie Centrum Psychogeriatrii | Recruiting | Bia?ystok | 15-756 | Poland |
| Uniwersyteckie Centrum Kliniczne | Recruiting | Gdansk | 80-214 | Poland |
| Szpital Uniwersytecki w Krakowie | Recruiting | Krakow | 30-688 | Poland |
| Clinical Research Center Sp. z o.o. MEDIC-R Spó?ka Komandytowa | Recruiting | Późna | 61-731 | Poland |
| Centrum Medyczne "MEDYK" | Recruiting | Rzeszów | 35-326 | Poland |
| Senior Sp. Z O.O. Poradnia Psychogeriatryczna | Recruiting | Sopot | 81-855 | Poland |
| NeuroProtect | Recruiting | Warsaw | 01-684 | Poland |
| Pusan National University Hospital | Recruiting | Busan | 602-739 | South Korea |
| Chonnam National University Hospital | Recruiting | Gwangju | 61469 | South Korea |
| Ajou University Medical Center | Recruiting | Gyeonggi-do | 16499 | South Korea |
| St. Vincent's Hospital | Recruiting | Gyeonggi-do | 442-723 | South Korea |
| Gachon University Gil Medical Center | Recruiting | Incheon | 21565 | South Korea |
| Inha University Hospital | Recruiting | Incheon | 22332 | South Korea |
| Seoul National University Bundang Hospital | Recruiting | Seongnam-si | 463-707 | South Korea |
| Hanyang University Seoul Hospital | Recruiting | Seoul | 04763 | South Korea |
| Asan Medical Center | Recruiting | Seoul | 05505 | South Korea |
| Samsung Medical Center | Recruiting | Seoul | 06351 | South Korea |
| Ewha Womans University Hospital (Seoul) | Recruiting | Seoul | 07804 | South Korea |
| Korea University Guro Hospital | Recruiting | Seoul | 08308 | South Korea |
| Hospital Universitario Marques de Valdecilla | Recruiting | Santander | Cantabria | 39011 | Spain |
| Fundación ACE | Recruiting | Barcelona | 08028 | Spain |
| Hospital de la Santa Creu i Sant Pau | Recruiting | Barcelona | 08041 | Spain |
| Hospital Ramon y Cajal | Recruiting | Madrid | 28034 | Spain |
| Hospital Universitario 12 de Octubre | Recruiting | Madrid | 28041 | Spain |
| Hospital Victoria Eugenia | Recruiting | Seville | 41009 | Spain |
| Hospital Virgen del Rocío | Recruiting | Seville | 41013 | Spain |
| Hospital Universitario la Fe | Recruiting | Valencia | 46026 | Spain |
| Inselspital Bern Medizin Neurologie | Recruiting | Bern | 3010 | Switzerland |
| Hôpitaux universitaires de Genève | Active, not recruiting | Geneva | 1211 | Switzerland |
| CHUV Lausanne Méd.Neurologie | Active, not recruiting | Lausanne | 1011 | Switzerland |
| Ospedale Regionale di Lugano - Civico | Active, not recruiting | Lugano | 6903 | Switzerland |
| ReMind UK | Recruiting | Bath | BA1 3NG | United Kingdom |
| Re:Cognition Health Birmingham | Recruiting | Birmingham | B16 8QQ | United Kingdom |
| Scottish Brain Sciences | Recruiting | Edinburgh | EH12 9DQ | United Kingdom |
| Queen Elizabeth University Hospital Glasgow | Recruiting | Glasgow | G51 4TF | United Kingdom |
| St George?s Hospital | Recruiting | London | SW17 ORE | United Kingdom |
| RE:Cognition Health | Recruiting | London | W1G 8TA | United Kingdom |
| UCL Institute of Neurology | Recruiting | London | WC1N 3BG | United Kingdom |
| Manchester Mental Health and Social Care Trust | Recruiting | Manchester | M13 9WL | United Kingdom |
| Warneford Hospital | Recruiting | Oxford | OX3 7JX | United Kingdom |
| Lancashire and South Cumbria NHS Foundation Trust | Recruiting | Preston | PR2 8DW | United Kingdom |
| Southampton University Hospitals NHS Trust | Recruiting | Southampton | SO16 6YD | United Kingdom |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |
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