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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-518006-40-00 | EU Trial (CTIS) Number |
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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: WN45443 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 |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Recruiting | Birmingham | Alabama | 35233 | 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 |
| Banner Sun Health Research Institute |
| Recruiting |
| Sun City |
| Arizona |
| 85351 |
| United States |
| Irvine Center for Clinical Research | Recruiting | Irvine | California | 92614 | United States |
| Inglewood Clinicals | Recruiting | Los Angeles | California | 90056 | United States |
| UCSF - Memory and Aging Center | Recruiting | San Francisco | California | 94158 | United States |
| Syrentis Clinical Research | Recruiting | Santa Ana | California | 92705 | United States |
| K2 Medical Research - The Villages | Recruiting | Lady Lake | Florida | 32159 | United States |
| K2 Medical Research, LLC | Recruiting | Maitland | Florida | 32751 | United States |
| Renstar Medical Research | Recruiting | Ocala | Florida | 34470 | United States |
| Axiom Brain Health LLC | Recruiting | Tampa | Florida | 33609 | United States |
| Charter Research - Lady Lake/The Villages | Recruiting | The Villages | Florida | 32162 | United States |
| Alzheimer?s Research and Treatment Center | Recruiting | Wellington | Florida | 33414 | United States |
| Conquest Research, LLC | Recruiting | Winter Park | Florida | 32789 | United States |
| Alzheimer's Research and Treatment Center - Columbus | Recruiting | Columbus | Georgia | 31904 | United States |
| Accel Research Sites-NeuroStudies | Recruiting | Decatur | Georgia | 30030 | United States |
| Hawaii Pacific Neuroscience | Recruiting | Honolulu | Hawaii | 96817 | United States |
| RE:Cognition (Chicago) | Recruiting | Chicago | Illinois | 60611 | United States |
| Tandem Clinical Research, LLC | Recruiting | Marrero | Louisiana | 70072 | United States |
| Brigham and Womens Hospital | Recruiting | Boston | Massachusetts | 02115 | United States |
| Boston Center for Memory | Recruiting | Newton | Massachusetts | 02459 | United States |
| Washington University School of Medicine | Recruiting | St Louis | Missouri | 63110 | United States |
| The Cognitive and Research Center of New Jersey | Recruiting | Ridgewood | New Jersey | 07450 | United States |
| Basil Clinical | Recruiting | Laurelton | New York | 11413-2016 | United States |
| Weill Cornell Medical College | Recruiting | New York | New York | 10021 | United States |
| Adams Clinical Harlem | Recruiting | New York | New York | 10029 | United States |
| Adams Clinical Bronx | Recruiting | The Bronx | New York | 10461 | United States |
| Triad Clinical Trials | Recruiting | Greensboro | North Carolina | 27410 | United States |
| Ohio State University | Recruiting | Columbus | Ohio | 43221 | United States |
| Butler Hospital | Recruiting | Providence | Rhode Island | 02906 | United States |
| Genesis Neuroscience Clinic | Recruiting | Knoxville | Tennessee | 37909 | United States |
| K2 Medical Research - Nashville | Recruiting | Nashville | Tennessee | 37204 | United States |
| Kerwin Research Center, LLC | Recruiting | Dallas | Texas | 75231 | United States |
| South Texas Research Institute - Edinburg | Recruiting | Edinburg | Texas | 78539 | United States |
| Re:Cognition Health - Houston | Recruiting | Houston | Texas | 77030 | United States |
| National Clinical Research Inc.-Richmond | Recruiting | Richmond | Virginia | 23294 | United States |
| Hospital Italiano | Recruiting | CABA | C1199ABA | Argentina |
| Sanatorio del Sur S.A. | Recruiting | San Miguel de Tucumán | T4000IDK | Argentina |
| Hospital das Clinicas - UFMG | Recruiting | Belo Horizonte | Minas Gerais | 31270-901 | Brazil |
| Hospital Moinhos de Vento | Recruiting | Porto Alegre | Rio Grande do Sul | 90035-001 | Brazil |
| Centro de Pesquisas Clinicas - CPCLIN | Recruiting | São Paulo | São Paulo | 01228-200 | Brazil |
| Richmond Clinical Trials | Recruiting | Richmond | British Columbia | V6V 2L1 | Canada |
| Baycrest Academy for Research and Education | Recruiting | North YORK | Ontario | M6A 2E1 | Canada |
| Toronto Memory Program | Recruiting | Toronto | Ontario | M3B 2S7 | Canada |
| Centricity East York | Recruiting | Toronto | Ontario | M4G 3E8 | Canada |
| Toronto Western Hospital | Recruiting | Toronto | Ontario | M5T 2S8 | Canada |
| Clinique Memoire de Montreal | Recruiting | Montreal | Quebec | H2X 3B9 | Canada |
| Alpha Recherche Clinique | Recruiting | Québec | G3K 2P8 | Canada |
| The Affiliated Hospital of Xuzhou Medical University | Recruiting | Xuzhou | Jiangsu | 221002 | China |
| Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | 200127 | China |
| Peking University First Hospital | Recruiting | Beijing | 100034 | China |
| Beijing Friendship Hospital Affiliated of Capital University of Medical Science | Recruiting | Beijing | 100050 | China |
| Beijing Tiantan Hospital,Capital Medical University | Recruiting | Beijing | 100050 | China |
| Peking University Sixth Hospital | Recruiting | Beijing | 100083 | China |
| The First Hospital of Jilin University | Recruiting | Changchun | 130021 | China |
| West China Hospital - Sichuan University | Recruiting | Chengdu | 610047 | China |
| The First Affiliated Hospital, Chongqing Medical University | Recruiting | Chongqing | 400016 | China |
| Fujian Medical University Union Hospital | Recruiting | Fuzhou | 350001 | China |
| Guangdong General Hospital | Recruiting | Guangzhou | 510030 | China |
| The second Affiliated Hospital of Guangzhou Medical University | Recruiting | Guangzhou | 510260 | China |
| Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University | Recruiting | Hangzhou | 310016 | China |
| The First Affiliated Hospital of Anhui Medical University | Recruiting | Hefei | 230022 | China |
| Anhui Provincial Hospital | Active, not recruiting | Hefei | 230088 | China |
| Zhongda Hospital Affiliated to Southeast University | Recruiting | Nanjing | 210009 | China |
| Nanjing Brain Hospital | Recruiting | Nanjing | 210029 | China |
| Nanjing First Hospital | Recruiting | Nanjing | 210029 | China |
| Ruijin Hospital Shanghai Jiaotong University School of Medicine | Recruiting | Shanghai | 200025 | China |
| Huashan Hospital, Fudan University | Recruiting | Shanghai | 200040 | China |
| Shanghai First People's Hospital | Recruiting | Shanghai | 200080 | China |
| Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | 200233 | China |
| Shanghai Pudong Hospital | Recruiting | Shanghai | 201399 | China |
| The Second Affiliated Hospital of Soochow University | Recruiting | Suzhou | 215004 | China |
| Tianjin Medical University General Hospital | Recruiting | Tianjin | 300052 | China |
| Hôpital Broca | Active, not recruiting | Le Kremlin Bicétre Cedex | 94275 | France |
| Hopital B Roger Salengro | Active, not recruiting | Lille | 59037 | France |
| Hôpital de la Timone | Active, not recruiting | Marseille | 13385 | France |
| Hopital Lariboisiere | Active, not recruiting | Paris | 75475 | France |
| CHU Rennes - Hopital Pontchaillou | Active, not recruiting | Rennes | 35033 | France |
| Gerontopole | Active, not recruiting | Toulouse | 31059 | France |
| CHRU - Hôpital Bretonneau | Active, not recruiting | Tours | 37000 | France |
| Hôpital de Brabois | Active, not recruiting | Vandœuvre-lès-Nancy | 54500 | France |
| Hopital des Charpennes | Active, not recruiting | Villeurbanne | 69100 | France |
| Uniklinik RWTH Aachen | Recruiting | Aachen | 52074 | Germany |
| Zentrum für klinische Forschung Dr. med. Irma Schöll | Recruiting | Bad Homburg | 61348 | Germany |
| Klinikum Bayreuth Standort Hohe Warte Klinik fur Neurologie | Recruiting | Bayreuth | 95445 | Germany |
| St. Josef-Hospital, Klinik für Neurologie | Recruiting | Bochum | 44791 | Germany |
| Gesundheit Nord, Klinikum Bremen-Ost | Recruiting | Bremen | 28325 | Germany |
| NeuroCentrum Odenwald | Recruiting | Erbach/Odenwald | 64711 | Germany |
| Universitätsklinikum Freiburg, Klinik für Neurologie und Neurophysiologie | Recruiting | Freiburg im Breisgau | 79106 | Germany |
| MVZ Rheumatologie und Autoimummedizin Hamburg GmbH | Recruiting | Hamburg | 20095 | Germany |
| Neurology UKSH Campus Kiel | Recruiting | Kiel | 24105 | Germany |
| Klinikum rechts der Isar der TU München | Recruiting | München | 81675 | Germany |
| Gemeinschaftspraxis Dr. Wolfram von Pannwitz, MBA & Dr. med. Marie Perle Brinckmann | Recruiting | Steglitz | 12163 | Germany |
| Krankenhaus der Barmherzigen Brüder Trier | Recruiting | Trier | 54292 | Germany |
| Universitätsklinikum Ulm | Recruiting | Ulm | 89081 | Germany |
| Fondazione Santa Lucia IRCCS | Recruiting | Rome | Lazio | 00179 | Italy |
| Umberto I Policlinico di Roma-Università di Roma La Sapienza | Recruiting | Rome | Lazio | 00185 | Italy |
| Azienda Ospedaliero Universitaria San Martino | Recruiting | Genoa | Liguria | 16132 | Italy |
| Asst Degli Spedali Civili Di Brescia | Recruiting | Brescia | Lombardy | 25123 | Italy |
| IRCCS Ospedale San Raffaele | Recruiting | Milan | Lombardy | 20132 | Italy |
| Kyoto University Hospital | Recruiting | Kyoto | 606-8507 | Japan |
| National Hospital Organization Utano National Hospital | Recruiting | Kyoto | 616-8255 | Japan |
| Mishuku Hospital | Recruiting | Meguro-Ku | 153-0051 | Japan |
| Mie University Hospital | Recruiting | Mie | 514-8507 | Japan |
| Memory Clinic Ochanomizu | Recruiting | Tokyo | 113-0034 | Japan |
| Keio University Hospital | Recruiting | Tokyo | 160-8582 | Japan |
| Tokyo Metropolitan Institute for Geriatrics and Gerontology | Recruiting | Tokyo | 173-0015 | Japan |
| National Center of Neurology and Psychiatry | Recruiting | Tokyo | 187-8551 | Japan |
| Federation of National Public Service Personnel Mutual Aid Associations Tachikawa Hospital | Recruiting | Tokyo | 190-8531 | Japan |
| P-One Clinic | Recruiting | Tokyo | 192-0071 | Japan |
| Yamagata Tokusyukai Hospital | Recruiting | Yamagata | 990-0834 | Japan |
| Centrum Medyczne Neuromed Sp. z.o.o. | Recruiting | Bydgoszcz | 85-163 | Poland |
| NEURO-CARE Sp. z o.o. Sp. Komandytowa | Recruiting | Katowice | 40-749 | Poland |
| Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii K | Recruiting | Krakow | 31-505 | Poland |
| Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak. | Recruiting | Lublin | 20-410 | Poland |
| Nmedis sp. z o.o. | Recruiting | Rzeszów | 35-323 | Poland |
| ETG Neuroscience Sp. z o.o. | Recruiting | Warsaw | 02-677 | Poland |
| Centrum Leczenia Zaburzen Pamieci | Recruiting | Warsaw | 03-839 | Poland |
| NZOZ WCA | Recruiting | Wroc?aw | 53-659 | Poland |
| SPSK nr 1 | Recruiting | Zabrze | 41-800 | Poland |
| Hospital General De Catalunya | Recruiting | Sant Cugat del Vallès | Barcelona | 8195 | Spain |
| Hospital Mutua De Terrasa | Recruiting | Terrassa | Barcelona | 08222 | Spain |
| Policlínica Guipuzcoa | Recruiting | Donostia / San Sebastian | Guipuzcoa | 20014 | Spain |
| Hospital Universitario de Santa Maria | Recruiting | Lleida | Lerida | 25198 | Spain |
| Hospital Quiron de Madrid | Recruiting | Pozuelo de Alarcón | Madrid | 28223 | Spain |
| Hospital Vall d'Hebron | Recruiting | Barcelona | 08035 | Spain |
| Hospital Universitario Reina Sofia | Recruiting | Córdoba | 14004 | Spain |
| Hospital Universitario de la Princesa | Recruiting | Madrid | 28006 | Spain |
| Hospital Universitario Dr. Peset | Recruiting | Valencia | 46017 | Spain |
| Kaohsiung Medical University Hospital | Recruiting | Kaohsiung City | 807 | Taiwan |
| Taipei Medical University ?Shuang Ho Hospital | Recruiting | New Taipei City | 23561 | Taiwan |
| China Medical University Hospital | Recruiting | North Dist. | 40447 | Taiwan |
| Taichung Veterans General Hospital | Recruiting | Taichung | 40705 | Taiwan |
| National Taiwan University Hospital | Recruiting | Taipei | 100 | Taiwan |
| Taipei Veterans General Hospital | Recruiting | Taipei | 11217 | Taiwan |
| Chang Gung Medical Foundation Linkou Branch | Recruiting | Taoyuan City | 333 | Taiwan |
| Lynfield Mount hospital | Recruiting | Bradford | BD9 6DP | United Kingdom |
| Recognition Health Bristol | Recruiting | Bristol | BS32 4SY | United Kingdom |
| Surrey and Borders NHS Foundation Trust | Recruiting | Chertsey | KT16 9AU | United Kingdom |
| Department of Old Age Psychiatry Kings College | Recruiting | London | SE5 8AF | United Kingdom |
| RE:Cognition Health | Recruiting | London | W1G 8TA | United Kingdom |
| Charing Cross Hospital | Recruiting | London | W6 8RF | United Kingdom |
| Campus for Ageing & Vitality | Recruiting | Newcastle | NE4 5PL | United Kingdom |
| Tees,Esk and Wear Valleys NHS Foundation Trust | Recruiting | York | YO31 8TA | 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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