A Clinical Trial of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease | NCT07170150 | Trialant

A Clinical Trial of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease | NCT07170150 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: 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

Banner Alzheimer?s InstituteRecruiting

Phoenix, Arizona 85006, United States

Sun Valley Research Center, Inc.Recruiting

Imperial, California 92251, United States

Healthy Brain ClinicRecruiting

Long Beach, California 90804, United States

Oakland ClinicalRecruiting

Oakland, California 94609, United States

Riverside ClinicalRecruiting

Riverside, California 92506, United States

Cenexel California Neuroscience Research, LLCRecruiting

Sherman Oaks, California 91403, United States

Yale UniversityRecruiting

New Haven, Connecticut 06510, United States

JEM Research LLCRecruiting

Atlantis, Florida 33462, United States

K2 Medical Research-Winter GardenRecruiting

Clermont, Florida 34711, United States

Visionary Investigators Network- Neurology AventuraRecruiting

Miami, Florida 33133, United States

Charter Research - Winter Park/OrlandoRecruiting

Orlando, Florida 32803, United States

Conquest Research - Lake NonaRecruiting

Orlando, Florida 32832, United States

Alzheimer's Research and Treatment CenterRecruiting

Stuart, Florida 34996, United States

CenExel iResearch, LLCRecruiting

Decatur, Georgia 30030, United States

Center for Advanced Research & EducationRecruiting

Gainesville, Georgia 30501, United States

Great Lakes Clinical Trials Chicago d/b/a Flourish Research AndersonvilleRecruiting

Chicago, Illinois 60640, United States

Adams Clinical BostonRecruiting

Boston, Massachusetts 02116, United States

Adams Clinical WatertownRecruiting

Watertown, Massachusetts 02472, United States

Quest Research InstituteRecruiting

Farmington Hills, Michigan 48334, United States

University of Nebraska Medical CenterRecruiting

Omaha, Nebraska 68198-8440, United States

The Cognitive and Research Center of New JerseyRecruiting

Springfield, New Jersey 07081, United States

IMA Clinical Research - AlbuquerqueRecruiting

Albuquerque, New Mexico 87109, United States

AD-CARE, University of Rochester Medical CenterRecruiting

Rochester, New York 14620, United States

Summit Research Network Inc.Recruiting

Portland, Oregon 97210, United States

Flourish Research ? PhiladelphiaRecruiting

Plymouth Meeting, Pennsylvania 19462, United States

Palmetto Clinical TrialsRecruiting

Summerville, South Carolina 29485, United States

Gadolin Research, LLCRecruiting

Beaumont, Texas 77702, United States

Kerwin Medical CenterRecruiting

Dallas, Texas 75216, United States

Re:Cognition Health - Fort WorthRecruiting

Fort Worth, Texas 76104, United States

Mt.Olympus Medical ResearchRecruiting

Katy, Texas 77450, United States

El Faro Health and TherapeuticsRecruiting

Rio Grande City, Texas 78582, United States

Sana Research, LLCRecruiting

Arlington, Virginia 22205, United States

Re:Cognition HealthRecruiting

Fairfax, Virginia 22031, United States

INECO Neurociencias OronoRecruiting

Rosario, Santa Fe Province S2000DTC, Argentina

CIERRecruiting

C. A. B. A., C1055AAF, Argentina

Fundacion ScherbovskyRecruiting

Mendoza, 5500, Argentina

Royal Prince Alfred HospitalRecruiting

Camperdown, New South Wales 2050, Australia

Southern NeurologyRecruiting

Kogarah, New South Wales 2217, Australia

KaRa Institute of Neurological DiseasesRecruiting

Macquarie Park, New South Wales 2113, Australia

Flinders Medical CentreRecruiting

Bedford Park, South Australia 5042, Australia

Queen Elizabeth HospitalRecruiting

Woodville, South Australia 5011, Australia

Box Hill HospitalRecruiting

Box Hill, Victoria 3128, Australia

Austin HealthRecruiting

Heidelberg, Victoria 3084, Australia

Alfred HospitalRecruiting

Melbourne, Victoria 3004, Australia

Alzheimer?s Research AustraliaRecruiting

Nedlands, Western Australia 6009, Australia

L2 Ip Instituto de Pesquisas Clinicas Ltda MERecruiting

Brasília, Federal District 70200-730, Brazil

Instituto de Neurologia de CuritibaRecruiting

Curitiba, Paraná 81210-310, Brazil

Clinica Clinilive ltdaRecruiting

Maringá, Paraná 87013-250, Brazil

Instituto do Cerebro do Rio Grande do SulRecruiting

Porto Alegre, Rio Grande do Sul 90610-000, Brazil

Clinica NeurologicaRecruiting

Joinville, Santa Catarina 89202-190, Brazil

CEMEC - Centro Multidisciplinar de Estudos ClínicosRecruiting

São Bernardo do Campo, São Paulo 09715-090, Brazil

Okanagan Clinical TrialsRecruiting

Kelowna, British Columbia V1Y 1Z9, Canada

Centricity ResearchRecruiting

Halifax, Nova Scotia B3S 1N2, Canada

Parkwood Institute Main BuildingRecruiting

London, Ontario N6C0A7, Canada

The Ottawa Memory ClinicRecruiting

Ottawa, Ontario K1Z 1G3, Canada

Kawartha Centre - Redefining Healthy AgingRecruiting

Peterborough, Ontario K9H 2P4, Canada

Sunnybrook Health Sciences CentreRecruiting

Toronto, Ontario M4N 3M5, Canada

St. Michael's HospitalRecruiting

Toronto, Ontario M5B 1W8, Canada

Genge Partners Inc.Recruiting

Montreal, Quebec H4A 3T2, Canada

Aalborg UniversitetshospitalRecruiting

Aalborg, 9000, Denmark

Aarhus Universitetshospital SkejbyRecruiting

Aarhus N, 8200, Denmark

Rigshospitalet, HukommelsesklinikkenRecruiting

København Ø, 2100, Denmark

CHU Amiens Hopital SudActive, not recruiting

Amiens Cedex1, 80054, France

Centre Hospitalier Universitaire de Bordeaux Hopital PellegrinActive, not recruiting

Bordeaux, 33076, France

Groupement Hospitalier Est - Hôpital NeurologiqueActive, not recruiting

Bron, 69677, France

CHU Dupruytren - LimogesActive, not recruiting

Limoges, 87042, France

Hopital Gui de ChauliacActive, not recruiting

Montpellier, 34295, France

Ch Pitie SalpetriereActive, not recruiting

Paris, 75651, France

CHU de Rouen HopitalWithdrawn

Rouen, 76031, France

Hop Guillaume Et Rene LaennecActive, not recruiting

Saint-Herblain, 44800, France

Hôpital RobertsauActive, not recruiting

Strasbourg, 67000, France

Universitaetsklinikum ErlangenRecruiting

Erlangen, Bavaria 91054, Germany

Ambulates Gesundheitszentrum der Charité GmbHRecruiting

Berlin, 12200, Germany

ECRC Experimental and Clinical Research Center, Charité Campus Berlin Buch, Memory ClinicRecruiting

Berlin, 13125, Germany

German Center for Neurodegenerative Diseases (DZNE)Recruiting

Bonn, 53127, Germany

Universitätsklinikum KölnRecruiting

Cologne, 50937, Germany

Medizinische Fakultät Carl Gustav CarusRecruiting

Dresden, 01307, Germany

Universitätsklinikum des Saarlandes Klinik f. Psychiatrie und PsychotherapieRecruiting

Homburg/Saar, 66421, Germany

Universitätsklinikum Jena, Klinik für NeurologieRecruiting

Jena, 07747, Germany

Universität LeipzigRecruiting

Leipzig, 04103, Germany

Otto-von-Guericke-Universität MagdeburgRecruiting

Magdeburg, 39120, Germany

Zentralinstitut für Seelische Gesundheit Abt.GerontopsychiatrieRecruiting

Mannheim, 68159, Germany

LMU Klinikum, Neurologische Klinik und PoliklinikRecruiting

München, 81377, Germany

Ludwig-Maximilians-Univ.Withdrawn

München, 81377, Germany

Universitätsklinikum MünsterRecruiting

Münster, 48149, Germany

Neuropraxis München SüdRecruiting

Unterhaching, 82008, Germany

A. O. U. Federico IIRecruiting

Naples, Campania 80131, Italy

Nuovo Ospedale Civile S. Agostino-EstenseRecruiting

Modena, Emilia-Romagna 41126, Italy

Policlinico Universitario Agostino GemelliRecruiting

Rome, Lazio 00168, Italy

Ospedale Isola Tiberina - Gemelli IsolaRecruiting

Rome, Lazio 00186, Italy

AO di Perugia - Ospedale S. Maria della MisericordiaActive, not recruiting

Perugia, Umbria 06156, Italy

Brain Attack Center Ota Memorial HospitalRecruiting

Hiroshima, 720-0825, Japan

National Hospital Organization Hiroshima-Nishi Medical CenterRecruiting

Hiroshima, 739-0696, Japan

Kobe University HospitalRecruiting

Hyōgo, 650-0017, Japan

Kagawa University HospitalRecruiting

Kagawa, 761-0793, Japan

Kochi Medical School HospitalRecruiting

Kochi, 783-8505, Japan

Okayama City HospitalRecruiting

Okayama, 700-8557, Japan

Rijikai Medical Corporation Katayama Medical ClinicRecruiting

Okayama, 710-0813, Japan

Kotobuki Social Medical Corporation Tominaga ClinicRecruiting

Osaka, 556-0015, Japan

The University of Tokyo HospitalRecruiting

Tokyo, 113-8655, Japan

Higashi-Shinjuku ClinicRecruiting

Tokyo, 169-0072, Japan

Brain Research Center Den BoschActive, not recruiting

's-Hertogenbosch, 5223 LA, Netherlands

Brain Research Center B.VActive, not recruiting

Amsterdam, 1081 GN, Netherlands

Brain Research Center ZwolleActive, not recruiting

Zwolle, 8025AZ, Netherlands

O?rodek Badawczo-Naukowo-Dydaktyczny Chorób Ot?piennych w ?cinawieActive, not recruiting

?cinawa, 59-330, Poland

ProNeuro Centrum MedyczneActive, not recruiting

?ory, 44-240, Poland

Uniwersytet Medyczny w LodziActive, not recruiting

?ód?, 92-216, Poland

Syberka-ClinHouse Sp. z o.o.Recruiting

B?dzin, 42-500, Poland

Podlaskie Centrum PsychogeriatriiActive, not recruiting

Bia?ystok, 15-756, Poland

Uniwersyteckie Centrum KliniczneActive, not recruiting

Gdansk, 80-214, Poland

Szpital Uniwersytecki w KrakowieActive, not recruiting

Krakow, 30-688, Poland

Clinical Research Center Sp. z o.o. MEDIC-R Spó?ka KomandytowaActive, not recruiting

Późna, 61-731, Poland

Centrum Medyczne "MEDYK"Active, not recruiting

Rzeszów, 35-326, Poland

Senior Sp. Z O.O. Poradnia PsychogeriatrycznaActive, not recruiting

Sopot, 81-855, Poland

NeuroProtectActive, not recruiting

Warsaw, 01-684, Poland

Pusan National University HospitalActive, not recruiting

Busan, 602-739, South Korea

Chonnam National University HospitalActive, not recruiting

Gwangju, 61469, South Korea

Ajou University Medical CenterActive, not recruiting

Gyeonggi-do, 16499, South Korea

St. Vincent's HospitalActive, not recruiting

Gyeonggi-do, 442-723, South Korea

Gachon University Gil Medical CenterActive, not recruiting

Incheon, 21565, South Korea

Inha University HospitalActive, not recruiting

Incheon, 22332, South Korea

Seoul National University Bundang HospitalActive, not recruiting

Seongnam-si, 463-707, South Korea

Hanyang University Seoul HospitalActive, not recruiting

Seoul, 04763, South Korea

Asan Medical CenterActive, not recruiting

Seoul, 05505, South Korea

Samsung Medical CenterActive, not recruiting

Seoul, 06351, South Korea

Ewha Womans University Hospital (Seoul)Active, not recruiting

Seoul, 07804, South Korea

Korea University Guro HospitalActive, not recruiting

Seoul, 08308, South Korea

Hospital Universitario Marques de ValdecillaRecruiting

Santander, Cantabria 39011, Spain

Fundación ACERecruiting

Barcelona, 08028, Spain

Hospital de la Santa Creu i Sant PauRecruiting

Barcelona, 08041, Spain

Hospital Ramon y CajalRecruiting

Madrid, 28034, Spain

Hospital Universitario 12 de OctubreRecruiting

Madrid, 28041, Spain

Hospital Victoria EugeniaRecruiting

Seville, 41009, Spain

Hospital Virgen del RocíoRecruiting

Seville, 41013, Spain

Hospital Universitario la FeRecruiting

Valencia, 46026, Spain

Inselspital Bern Medizin NeurologieActive, not recruiting

Bern, 3010, Switzerland

Hôpitaux universitaires de GenèveActive, not recruiting

Geneva, 1211, Switzerland

CHUV Lausanne Méd.NeurologieActive, not recruiting

Lausanne, 1011, Switzerland

Ospedale Regionale di Lugano - CivicoActive, not recruiting

Lugano, 6903, Switzerland

ReMind UKRecruiting

Bath, BA1 3NG, United Kingdom

Re:Cognition Health BirminghamRecruiting

Birmingham, B16 8QQ, United Kingdom

Scottish Brain SciencesRecruiting

Edinburgh, EH12 9DQ, United Kingdom

Queen Elizabeth University Hospital GlasgowRecruiting

Glasgow, G51 4TF, United Kingdom

St George?s HospitalRecruiting

London, SW17 ORE, United Kingdom

RE:Cognition HealthRecruiting

London, W1G 8TA, United Kingdom

UCL Institute of NeurologyRecruiting

London, WC1N 3BG, United Kingdom

Manchester Mental Health and Social Care TrustRecruiting

Manchester, M13 9WL, United Kingdom

Warneford HospitalRecruiting

Oxford, OX3 7JX, United Kingdom

Lancashire and South Cumbria NHS Foundation TrustRecruiting

Preston, PR2 8DW, United Kingdom

Southampton University Hospitals NHS TrustRecruiting

Southampton, SO16 6YD, United Kingdom