Actively Recruiting

Phase 3
Age: 50Years - 90Years
All Genders
NCT07169578

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

Led by Hoffmann-La Roche · Updated on 2026-05-04

800

Participants Needed

141

Research Sites

142 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 50Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Willingness and ability to complete all study procedures including MRI, clinical genotyping, and PET imaging or cerebrospinal fluid testing
  • Adequate vision and hearing to perform neuropsychological testing, with use of aids if needed
  • Confirmed Alzheimer's disease pathology by amyloid PET scan or cerebrospinal fluid tau181/Aβ42 ratio
  • Diagnosis of probable Alzheimer's dementia or mild cognitive impairment due to Alzheimer's (clinical Stage 3 or 4)
  • Mini-Mental State Examination (MMSE) score of 22 or higher and Clinical Dementia Rating-Global Score of 0.5 or 1.0
  • History of gradual cognitive decline reported by participant or informant over the past year
  • Repeatable Battery for the Assessment of Neuropsychological Status Delayed Memory Index score of 85 or higher
  • Availability of a study partner as defined by the protocol
Not Eligible

You will not qualify if you...

  • Presence of any condition other than Alzheimer's disease affecting cognition
  • History or signs of significant cerebrovascular disease
  • History of severe central nervous system trauma causing persistent neurological deficits or brain damage
  • History or presence of intracranial mass
  • MRI evidence of significant brain abnormalities or inability to tolerate MRI or contraindication to MRI
  • Any unstable or uncontrolled medical conditions, including cardiovascular, liver, or kidney disease, that could affect safety or study assessments
  • History of cancer except if considered cured or with negligible risk of spread or death

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 141 locations

1

Banner Sun Health Research Institute

Sun City, Arizona, United States, 85351

Actively Recruiting

2

Irvine Center for Clinical Research

Irvine, California, United States, 92614

Actively Recruiting

3

Inglewood Clinicals

Los Angeles, California, United States, 90056

Actively Recruiting

4

UCSF - Memory and Aging Center

San Francisco, California, United States, 94158

Actively Recruiting

5

Syrentis Clinical Research

Santa Ana, California, United States, 92705

Actively Recruiting

6

K2 Medical Research - The Villages

Lady Lake, Florida, United States, 32159

Actively Recruiting

7

K2 Medical Research, LLC

Maitland, Florida, United States, 32751

Actively Recruiting

8

Renstar Medical Research

Ocala, Florida, United States, 34470

Actively Recruiting

9

Axiom Brain Health LLC

Tampa, Florida, United States, 33609

Actively Recruiting

10

Charter Research - Lady Lake/The Villages

The Villages, Florida, United States, 32162

Actively Recruiting

11

Alzheimer?s Research and Treatment Center

Wellington, Florida, United States, 33414

Actively Recruiting

12

Conquest Research, LLC

Winter Park, Florida, United States, 32789

Actively Recruiting

13

Alzheimer's Research and Treatment Center - Columbus

Columbus, Georgia, United States, 31904

Actively Recruiting

14

Accel Research Sites-NeuroStudies

Decatur, Georgia, United States, 30030

Actively Recruiting

15

Hawaii Pacific Neuroscience

Honolulu, Hawaii, United States, 96817

Actively Recruiting

16

RE:Cognition (Chicago)

Chicago, Illinois, United States, 60611

Actively Recruiting

17

Tandem Clinical Research, LLC

Marrero, Louisiana, United States, 70072

Actively Recruiting

18

Boston Center for Memory

Newton, Massachusetts, United States, 02459

Actively Recruiting

19

Washington University School of Medicine

St Louis, Missouri, United States, 63110

Actively Recruiting

20

The Cognitive and Research Center of New Jersey

Ridgewood, New Jersey, United States, 07450

Actively Recruiting

21

Basil Clinical

Laurelton, New York, United States, 11413-2016

Actively Recruiting

22

Weill Cornell Medical College

New York, New York, United States, 10021

Actively Recruiting

23

Adams Clinical Harlem

New York, New York, United States, 10029

Actively Recruiting

24

Adams Clinical Bronx

The Bronx, New York, United States, 10461

Actively Recruiting

25

Triad Clinical Trials

Greensboro, North Carolina, United States, 27410

Actively Recruiting

26

Ohio State University

Columbus, Ohio, United States, 43221

Actively Recruiting

27

Butler Hospital

Providence, Rhode Island, United States, 02906

Actively Recruiting

28

Genesis Neuroscience Clinic

Knoxville, Tennessee, United States, 37909

Actively Recruiting

29

K2 Medical Research - Nashville

Nashville, Tennessee, United States, 37204

Actively Recruiting

30

Kerwin Research Center, LLC

Dallas, Texas, United States, 75231

Actively Recruiting

31

South Texas Research Institute - Edinburg

Edinburg, Texas, United States, 78539

Actively Recruiting

32

Re:Cognition Health - Houston

Houston, Texas, United States, 77030

Actively Recruiting

33

National Clinical Research Inc.-Richmond

Richmond, Virginia, United States, 23294

Actively Recruiting

34

Hospital Italiano

CABA, Argentina, C1199ABA

Actively Recruiting

35

Sanatorio del Sur S.A.

San Miguel de Tucumán, Argentina, T4000IDK

Actively Recruiting

36

Hospital das Clinicas - UFMG

Belo Horizonte, Minas Gerais, Brazil, 31270-901

Actively Recruiting

37

Hospital Moinhos de Vento

Porto Alegre, Rio Grande do Sul, Brazil, 90035-001

Actively Recruiting

38

Centro de Pesquisas Clinicas - CPCLIN

São Paulo, São Paulo, Brazil, 01228-200

Actively Recruiting

39

Richmond Clinical Trials

Richmond, British Columbia, Canada, V6V 2L1

Actively Recruiting

40

Baycrest Academy for Research and Education

North YORK, Ontario, Canada, M6A 2E1

Actively Recruiting

41

Toronto Memory Program

Toronto, Ontario, Canada, M3B 2S7

Actively Recruiting

42

Centricity East York

Toronto, Ontario, Canada, M4G 3E8

Actively Recruiting

43

Toronto Western Hospital

Toronto, Ontario, Canada, M5T 2S8

Actively Recruiting

44

Clinique Memoire de Montreal

Montreal, Quebec, Canada, H2X 3B9

Actively Recruiting

45

Alpha Recherche Clinique

Québec, Canada, G3K 2P8

Actively Recruiting

46

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China, 221002

Actively Recruiting

47

Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China, 200127

Actively Recruiting

48

Peking University First Hospital

Beijing, China, 100034

Actively Recruiting

49

Beijing Friendship Hospital Affiliated of Capital University of Medical Science

Beijing, China, 100050

Actively Recruiting

50

Beijing Tiantan Hospital,Capital Medical University

Beijing, China, 100050

Actively Recruiting

51

Peking University Sixth Hospital

Beijing, China, 100083

Actively Recruiting

52

The First Hospital of Jilin University

Changchun, China, 130021

Actively Recruiting

53

West China Hospital - Sichuan University

Chengdu, China, 610047

Actively Recruiting

54

The First Affiliated Hospital, Chongqing Medical University

Chongqing, China, 400016

Actively Recruiting

55

Fujian Medical University Union Hospital

Fuzhou, China, 350001

Actively Recruiting

56

Guangdong General Hospital

Guangzhou, China, 510030

Actively Recruiting

57

The second Affiliated Hospital of Guangzhou Medical University

Guangzhou, China, 510260

Actively Recruiting

58

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

Hangzhou, China, 310016

Actively Recruiting

59

The First Affiliated Hospital of Anhui Medical University

Hefei, China, 230022

Actively Recruiting

60

Anhui Provincial Hospital

Hefei, China, 230088

Actively Recruiting

61

Zhongda Hospital Affiliated to Southeast University

Nanjing, China, 210009

Actively Recruiting

62

Nanjing Brain Hospital

Nanjing, China, 210029

Actively Recruiting

63

Nanjing First Hospital

Nanjing, China, 210029

Actively Recruiting

64

Ruijin Hospital Shanghai Jiaotong University School of Medicine

Shanghai, China, 200025

Actively Recruiting

65

Huashan Hospital, Fudan University

Shanghai, China, 200040

Actively Recruiting

66

Shanghai First People's Hospital

Shanghai, China, 200080

Actively Recruiting

67

Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, China, 200233

Actively Recruiting

68

Shanghai Pudong Hospital

Shanghai, China, 201399

Actively Recruiting

69

The Second Affiliated Hospital of Soochow University

Suzhou, China, 215004

Actively Recruiting

70

Tianjin Medical University General Hospital

Tianjin, China, 300052

Actively Recruiting

71

Hôpital Broca

Le Kremlin Bicétre Cedex, France, 94275

Actively Recruiting

72

Hopital B Roger Salengro

Lille, France, 59037

Actively Recruiting

73

Hôpital de la Timone

Marseille, France, 13385

Actively Recruiting

74

Hopital Lariboisiere

Paris, France, 75475

Actively Recruiting

75

CHU Rennes - Hopital Pontchaillou

Rennes, France, 35033

Actively Recruiting

76

Gerontopole

Toulouse, France, 31059

Actively Recruiting

77

CHRU - Hôpital Bretonneau

Tours, France, 37000

Actively Recruiting

78

Hôpital de Brabois

Vandœuvre-lès-Nancy, France, 54500

Actively Recruiting

79

Hopital des Charpennes

Villeurbanne, France, 69100

Actively Recruiting

80

Uniklinik RWTH Aachen

Aachen, Germany, 52074

Actively Recruiting

81

Zentrum für klinische Forschung Dr. med. Irma Schöll

Bad Homburg, Germany, 61348

Actively Recruiting

82

Klinikum Bayreuth Standort Hohe Warte Klinik fur Neurologie

Bayreuth, Germany, 95445

Actively Recruiting

83

St. Josef-Hospital, Klinik für Neurologie

Bochum, Germany, 44791

Actively Recruiting

84

Gesundheit Nord, Klinikum Bremen-Ost

Bremen, Germany, 28325

Actively Recruiting

85

NeuroCentrum Odenwald

Erbach/Odenwald, Germany, 64711

Actively Recruiting

86

Universitätsklinikum Freiburg, Klinik für Neurologie und Neurophysiologie

Freiburg im Breisgau, Germany, 79106

Actively Recruiting

87

MVZ Rheumatologie und Autoimummedizin Hamburg GmbH

Hamburg, Germany, 20095

Actively Recruiting

88

Neurology UKSH Campus Kiel

Kiel, Germany, 24105

Actively Recruiting

89

Klinikum rechts der Isar der TU München

München, Germany, 81675

Actively Recruiting

90

Gemeinschaftspraxis Dr. Wolfram von Pannwitz, MBA & Dr. med. Marie Perle Brinckmann

Steglitz, Germany, 12163

Actively Recruiting

91

Krankenhaus der Barmherzigen Brüder Trier

Trier, Germany, 54292

Actively Recruiting

92

Universitätsklinikum Ulm

Ulm, Germany, 89081

Actively Recruiting

93

Fondazione Santa Lucia IRCCS

Rome, Lazio, Italy, 00179

Actively Recruiting

94

Umberto I Policlinico di Roma-Università di Roma La Sapienza

Rome, Lazio, Italy, 00185

Actively Recruiting

95

Azienda Ospedaliero Universitaria San Martino

Genoa, Liguria, Italy, 16132

Actively Recruiting

96

Asst Degli Spedali Civili Di Brescia

Brescia, Lombardy, Italy, 25123

Actively Recruiting

97

IRCCS Ospedale San Raffaele

Milan, Lombardy, Italy, 20132

Actively Recruiting

98

Kyoto University Hospital

Kyoto, Japan, 606-8507

Actively Recruiting

99

National Hospital Organization Utano National Hospital

Kyoto, Japan, 616-8255

Actively Recruiting

100

Mishuku Hospital

Meguro-Ku, Japan, 153-0051

Actively Recruiting

101

Mie University Hospital

Mie, Japan, 514-8507

Actively Recruiting

102

Memory Clinic Ochanomizu

Tokyo, Japan, 113-0034

Actively Recruiting

103

Keio University Hospital

Tokyo, Japan, 160-8582

Actively Recruiting

104

Tokyo Metropolitan Institute for Geriatrics and Gerontology

Tokyo, Japan, 173-0015

Actively Recruiting

105

National Center of Neurology and Psychiatry

Tokyo, Japan, 187-8551

Actively Recruiting

106

Federation of National Public Service Personnel Mutual Aid Associations Tachikawa Hospital

Tokyo, Japan, 190-8531

Actively Recruiting

107

P-One Clinic

Tokyo, Japan, 192-0071

Actively Recruiting

108

Yamagata Tokusyukai Hospital

Yamagata, Japan, 990-0834

Actively Recruiting

109

Centrum Medyczne Neuromed Sp. z.o.o.

Bydgoszcz, Poland, 85-163

Actively Recruiting

110

NEURO-CARE Sp. z o.o. Sp. Komandytowa

Katowice, Poland, 40-749

Actively Recruiting

111

Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii K

Krakow, Poland, 31-505

Actively Recruiting

112

Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak.

Lublin, Poland, 20-410

Actively Recruiting

113

Nmedis sp. z o.o.

Rzeszów, Poland, 35-323

Actively Recruiting

114

ETG Neuroscience Sp. z o.o.

Warsaw, Poland, 02-677

Actively Recruiting

115

Centrum Leczenia Zaburzen Pamieci

Warsaw, Poland, 03-839

Actively Recruiting

116

NZOZ WCA

Wroc?aw, Poland, 53-659

Actively Recruiting

117

SPSK nr 1

Zabrze, Poland, 41-800

Actively Recruiting

118

Hospital General De Catalunya

Sant Cugat del Vallès, Barcelona, Spain, 8195

Actively Recruiting

119

Hospital Mutua De Terrasa

Terrassa, Barcelona, Spain, 08222

Actively Recruiting

120

Policlínica Guipuzcoa

Donostia / San Sebastian, Guipuzcoa, Spain, 20014

Actively Recruiting

121

Hospital Universitario de Santa Maria

Lleida, Lerida, Spain, 25198

Actively Recruiting

122

Hospital Quiron de Madrid

Pozuelo de Alarcón, Madrid, Spain, 28223

Actively Recruiting

123

Hospital Vall d'Hebron

Barcelona, Spain, 08035

Actively Recruiting

124

Hospital Universitario Reina Sofia

Córdoba, Spain, 14004

Actively Recruiting

125

Hospital Universitario de la Princesa

Madrid, Spain, 28006

Actively Recruiting

126

Hospital Universitario Dr. Peset

Valencia, Spain, 46017

Actively Recruiting

127

Kaohsiung Medical University Hospital

Kaohsiung City, Taiwan, 807

Actively Recruiting

128

Taipei Medical University ?Shuang Ho Hospital

New Taipei City, Taiwan, 23561

Actively Recruiting

129

China Medical University Hospital

North Dist., Taiwan, 40447

Actively Recruiting

130

Taichung Veterans General Hospital

Taichung, Taiwan, 40705

Actively Recruiting

131

National Taiwan University Hospital

Taipei, Taiwan, 100

Actively Recruiting

132

Taipei Veterans General Hospital

Taipei, Taiwan, 11217

Actively Recruiting

133

Chang Gung Medical Foundation Linkou Branch

Taoyuan City, Taiwan, 333

Actively Recruiting

134

Lynfield Mount hospital

Bradford, United Kingdom, BD9 6DP

Actively Recruiting

135

Recognition Health Bristol

Bristol, United Kingdom, BS32 4SY

Actively Recruiting

136

Surrey and Borders NHS Foundation Trust

Chertsey, United Kingdom, KT16 9AU

Actively Recruiting

137

Department of Old Age Psychiatry Kings College

London, United Kingdom, SE5 8AF

Actively Recruiting

138

RE:Cognition Health

London, United Kingdom, W1G 8TA

Actively Recruiting

139

Charing Cross Hospital

London, United Kingdom, W6 8RF

Actively Recruiting

140

Campus for Ageing & Vitality

Newcastle, United Kingdom, NE4 5PL

Actively Recruiting

141

Tees,Esk and Wear Valleys NHS Foundation Trust

York, United Kingdom, YO31 8TA

Actively Recruiting

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Research Team

R

Reference Study ID Number: WN45443 https://forpatients.roche.com/

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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