Actively Recruiting
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease (MCI to Mild Dementia)
Led by Hoffmann-La Roche · Updated on 2026-06-03
800
Participants Needed
143
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of trontinemab in people with early symptomatic Alzheimer's disease, ranging from mild cognitive impairment to mild dementia caused by Alzheimer's. This Phase III study is designed as a multicenter, randomized, double-blind, placebo-controlled trial to better understand how trontinemab may impact cognitive and functional changes in this population. Participants will be randomly assigned to receive either intravenous (IV) trontinemab or an IV placebo. The treatment period lasts for 72 weeks, during which participants will receive regular infusions. This trial includes detailed monitoring of brain changes using PET scans, cerebrospinal fluid and blood biomarkers, and cognitive assessments. Throughout the study, participants will undergo multiple evaluations including cognitive tests such as the Clinical Dementia Rating Scale and MMSE, brain imaging scans for amyloid and tau, and safety monitoring for adverse events and immune responses. The study will also assess everyday functioning and collect data on biomarkers related to Alzheimer's disease. Participation requires a study partner and involves visits over approximately 72 weeks.
CONDITIONS
Brief Title
A Study of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willingness and ability to complete all study aspects including MRI, genotyping, and PET imaging or CSF as applicable
- Adequate vision and hearing to perform neuropsychological testing
- Evidence of Alzheimer's disease pathology confirmed by amyloid PET or CSF tau181/A2 ratio
- Diagnosis of probable Alzheimer's dementia or mild cognitive impairment due to Alzheimer's (clinical Stage 3 or 4)
- Screening MMSE score of 22 or higher and CDR-Global Score of 0.5 or 1.0
- History of cognitive decline with gradual onset and progression over the past year before screening
- 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
You will not qualify if you...
- Any condition other than Alzheimer's disease that may affect cognition
- History or presence of clinically significant cerebrovascular disease
- History of severe central nervous system trauma causing persistent neurological deficit or brain damage
- Clinically significant intracranial mass
- MRI evidence of significant brain abnormalities or contraindications to MRI
- Unstable or inadequately controlled medical conditions that may affect safety or study assessments
- History of malignancy except if cured or with negligible risk of metastasis or death
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 72 weeks
Participants receive intravenous (IV) trontinemab or placebo as part of the study treatment.
Regular visits for treatment and assessments up to Week 72
Trial Site Locations
Total: 143 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Banner Sun Health Research Institute
Sun City, Arizona, United States, 85351
Actively Recruiting
3
Irvine Center for Clinical Research
Irvine, California, United States, 92614
Actively Recruiting
4
Inglewood Clinicals
Los Angeles, California, United States, 90056
Actively Recruiting
5
UCSF - Memory and Aging Center
San Francisco, California, United States, 94158
Actively Recruiting
6
Syrentis Clinical Research
Santa Ana, California, United States, 92705
Actively Recruiting
7
K2 Medical Research - The Villages
Lady Lake, Florida, United States, 32159
Actively Recruiting
8
K2 Medical Research, LLC
Maitland, Florida, United States, 32751
Actively Recruiting
9
Renstar Medical Research
Ocala, Florida, United States, 34470
Actively Recruiting
10
Axiom Brain Health LLC
Tampa, Florida, United States, 33609
Actively Recruiting
11
Charter Research - Lady Lake/The Villages
The Villages, Florida, United States, 32162
Actively Recruiting
12
Alzheimer?s Research and Treatment Center
Wellington, Florida, United States, 33414
Actively Recruiting
13
Conquest Research, LLC
Winter Park, Florida, United States, 32789
Actively Recruiting
14
Alzheimer's Research and Treatment Center - Columbus
Columbus, Georgia, United States, 31904
Actively Recruiting
15
Accel Research Sites-NeuroStudies
Decatur, Georgia, United States, 30030
Actively Recruiting
16
Hawaii Pacific Neuroscience
Honolulu, Hawaii, United States, 96817
Actively Recruiting
17
RE:Cognition (Chicago)
Chicago, Illinois, United States, 60611
Actively Recruiting
18
Tandem Clinical Research, LLC
Marrero, Louisiana, United States, 70072
Actively Recruiting
19
Brigham and Womens Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
20
Boston Center for Memory
Newton, Massachusetts, United States, 02459
Actively Recruiting
21
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
22
The Cognitive and Research Center of New Jersey
Ridgewood, New Jersey, United States, 07450
Actively Recruiting
23
Basil Clinical
Laurelton, New York, United States, 11413-2016
Actively Recruiting
24
Weill Cornell Medical College
New York, New York, United States, 10021
Actively Recruiting
25
Adams Clinical Harlem
New York, New York, United States, 10029
Actively Recruiting
26
Adams Clinical Bronx
The Bronx, New York, United States, 10461
Actively Recruiting
27
Triad Clinical Trials
Greensboro, North Carolina, United States, 27410
Actively Recruiting
28
Ohio State University
Columbus, Ohio, United States, 43221
Actively Recruiting
29
Butler Hospital
Providence, Rhode Island, United States, 02906
Actively Recruiting
30
Genesis Neuroscience Clinic
Knoxville, Tennessee, United States, 37909
Actively Recruiting
31
K2 Medical Research - Nashville
Nashville, Tennessee, United States, 37204
Actively Recruiting
32
Kerwin Research Center, LLC
Dallas, Texas, United States, 75231
Actively Recruiting
33
South Texas Research Institute - Edinburg
Edinburg, Texas, United States, 78539
Actively Recruiting
34
Re:Cognition Health - Houston
Houston, Texas, United States, 77030
Actively Recruiting
35
National Clinical Research Inc.-Richmond
Richmond, Virginia, United States, 23294
Actively Recruiting
36
Hospital Italiano
CABA, Argentina, C1199ABA
Actively Recruiting
37
Sanatorio del Sur S.A.
San Miguel de Tucumán, Argentina, T4000IDK
Actively Recruiting
38
Hospital das Clinicas - UFMG
Belo Horizonte, Minas Gerais, Brazil, 31270-901
Actively Recruiting
39
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, Brazil, 90035-001
Actively Recruiting
40
Centro de Pesquisas Clinicas - CPCLIN
São Paulo, São Paulo, Brazil, 01228-200
Actively Recruiting
41
Richmond Clinical Trials
Richmond, British Columbia, Canada, V6V 2L1
Actively Recruiting
42
Baycrest Academy for Research and Education
North YORK, Ontario, Canada, M6A 2E1
Actively Recruiting
43
Toronto Memory Program
Toronto, Ontario, Canada, M3B 2S7
Actively Recruiting
44
Centricity East York
Toronto, Ontario, Canada, M4G 3E8
Actively Recruiting
45
Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
Actively Recruiting
46
Clinique Memoire de Montreal
Montreal, Quebec, Canada, H2X 3B9
Actively Recruiting
47
Alpha Recherche Clinique
Québec, Canada, G3K 2P8
Actively Recruiting
48
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China, 221002
Actively Recruiting
49
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China, 200127
Actively Recruiting
50
Peking University First Hospital
Beijing, China, 100034
Actively Recruiting
51
Beijing Friendship Hospital Affiliated of Capital University of Medical Science
Beijing, China, 100050
Actively Recruiting
52
Beijing Tiantan Hospital,Capital Medical University
Beijing, China, 100050
Actively Recruiting
53
Peking University Sixth Hospital
Beijing, China, 100083
Actively Recruiting
54
The First Hospital of Jilin University
Changchun, China, 130021
Actively Recruiting
55
West China Hospital - Sichuan University
Chengdu, China, 610047
Actively Recruiting
56
The First Affiliated Hospital, Chongqing Medical University
Chongqing, China, 400016
Actively Recruiting
57
Fujian Medical University Union Hospital
Fuzhou, China, 350001
Actively Recruiting
58
Guangdong General Hospital
Guangzhou, China, 510030
Actively Recruiting
59
The second Affiliated Hospital of Guangzhou Medical University
Guangzhou, China, 510260
Actively Recruiting
60
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Hangzhou, China, 310016
Actively Recruiting
61
The First Affiliated Hospital of Anhui Medical University
Hefei, China, 230022
Actively Recruiting
62
Anhui Provincial Hospital
Hefei, China, 230088
Actively Recruiting
63
Zhongda Hospital Affiliated to Southeast University
Nanjing, China, 210009
Actively Recruiting
64
Nanjing Brain Hospital
Nanjing, China, 210029
Actively Recruiting
65
Nanjing First Hospital
Nanjing, China, 210029
Actively Recruiting
66
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Shanghai, China, 200025
Actively Recruiting
67
Huashan Hospital, Fudan University
Shanghai, China, 200040
Actively Recruiting
68
Shanghai First People's Hospital
Shanghai, China, 200080
Actively Recruiting
69
Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, China, 200233
Actively Recruiting
70
Shanghai Pudong Hospital
Shanghai, China, 201399
Actively Recruiting
71
The Second Affiliated Hospital of Soochow University
Suzhou, China, 215004
Actively Recruiting
72
Tianjin Medical University General Hospital
Tianjin, China, 300052
Actively Recruiting
73
Hôpital Broca
Le Kremlin Bicétre Cedex, France, 94275
Actively Recruiting
74
Hopital B Roger Salengro
Lille, France, 59037
Actively Recruiting
75
Hôpital de la Timone
Marseille, France, 13385
Actively Recruiting
76
Hopital Lariboisiere
Paris, France, 75475
Actively Recruiting
77
CHU Rennes - Hopital Pontchaillou
Rennes, France, 35033
Actively Recruiting
78
Gerontopole
Toulouse, France, 31059
Actively Recruiting
79
CHRU - Hôpital Bretonneau
Tours, France, 37000
Actively Recruiting
80
Hôpital de Brabois
Vandœuvre-lès-Nancy, France, 54500
Actively Recruiting
81
Hopital des Charpennes
Villeurbanne, France, 69100
Actively Recruiting
82
Uniklinik RWTH Aachen
Aachen, Germany, 52074
Actively Recruiting
83
Zentrum für klinische Forschung Dr. med. Irma Schöll
Bad Homburg, Germany, 61348
Actively Recruiting
84
Klinikum Bayreuth Standort Hohe Warte Klinik fur Neurologie
Bayreuth, Germany, 95445
Actively Recruiting
85
St. Josef-Hospital, Klinik für Neurologie
Bochum, Germany, 44791
Actively Recruiting
86
Gesundheit Nord, Klinikum Bremen-Ost
Bremen, Germany, 28325
Actively Recruiting
87
NeuroCentrum Odenwald
Erbach/Odenwald, Germany, 64711
Actively Recruiting
88
Universitätsklinikum Freiburg, Klinik für Neurologie und Neurophysiologie
Freiburg im Breisgau, Germany, 79106
Actively Recruiting
89
MVZ Rheumatologie und Autoimummedizin Hamburg GmbH
Hamburg, Germany, 20095
Actively Recruiting
90
Neurology UKSH Campus Kiel
Kiel, Germany, 24105
Actively Recruiting
91
Klinikum rechts der Isar der TU München
München, Germany, 81675
Actively Recruiting
92
Gemeinschaftspraxis Dr. Wolfram von Pannwitz, MBA & Dr. med. Marie Perle Brinckmann
Steglitz, Germany, 12163
Actively Recruiting
93
Krankenhaus der Barmherzigen Brüder Trier
Trier, Germany, 54292
Actively Recruiting
94
Universitätsklinikum Ulm
Ulm, Germany, 89081
Actively Recruiting
95
Fondazione Santa Lucia IRCCS
Rome, Lazio, Italy, 00179
Actively Recruiting
96
Umberto I Policlinico di Roma-Università di Roma La Sapienza
Rome, Lazio, Italy, 00185
Actively Recruiting
97
Azienda Ospedaliero Universitaria San Martino
Genoa, Liguria, Italy, 16132
Actively Recruiting
98
Asst Degli Spedali Civili Di Brescia
Brescia, Lombardy, Italy, 25123
Actively Recruiting
99
IRCCS Ospedale San Raffaele
Milan, Lombardy, Italy, 20132
Actively Recruiting
100
Kyoto University Hospital
Kyoto, Japan, 606-8507
Actively Recruiting
101
National Hospital Organization Utano National Hospital
Kyoto, Japan, 616-8255
Actively Recruiting
102
Mishuku Hospital
Meguro-Ku, Japan, 153-0051
Actively Recruiting
103
Mie University Hospital
Mie, Japan, 514-8507
Actively Recruiting
104
Memory Clinic Ochanomizu
Tokyo, Japan, 113-0034
Actively Recruiting
105
Keio University Hospital
Tokyo, Japan, 160-8582
Actively Recruiting
106
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Tokyo, Japan, 173-0015
Actively Recruiting
107
National Center of Neurology and Psychiatry
Tokyo, Japan, 187-8551
Actively Recruiting
108
Federation of National Public Service Personnel Mutual Aid Associations Tachikawa Hospital
Tokyo, Japan, 190-8531
Actively Recruiting
109
P-One Clinic
Tokyo, Japan, 192-0071
Actively Recruiting
110
Yamagata Tokusyukai Hospital
Yamagata, Japan, 990-0834
Actively Recruiting
111
Centrum Medyczne Neuromed Sp. z.o.o.
Bydgoszcz, Poland, 85-163
Actively Recruiting
112
NEURO-CARE Sp. z o.o. Sp. Komandytowa
Katowice, Poland, 40-749
Actively Recruiting
113
Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii K
Krakow, Poland, 31-505
Actively Recruiting
114
Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak.
Lublin, Poland, 20-410
Actively Recruiting
115
Nmedis sp. z o.o.
Rzeszów, Poland, 35-323
Actively Recruiting
116
ETG Neuroscience Sp. z o.o.
Warsaw, Poland, 02-677
Actively Recruiting
117
Centrum Leczenia Zaburzen Pamieci
Warsaw, Poland, 03-839
Actively Recruiting
118
NZOZ WCA
Wroc?aw, Poland, 53-659
Actively Recruiting
119
SPSK nr 1
Zabrze, Poland, 41-800
Actively Recruiting
120
Hospital General De Catalunya
Sant Cugat del Vallès, Barcelona, Spain, 8195
Actively Recruiting
121
Hospital Mutua De Terrasa
Terrassa, Barcelona, Spain, 08222
Actively Recruiting
122
Policlínica Guipuzcoa
Donostia / San Sebastian, Guipuzcoa, Spain, 20014
Actively Recruiting
123
Hospital Universitario de Santa Maria
Lleida, Lerida, Spain, 25198
Actively Recruiting
124
Hospital Quiron de Madrid
Pozuelo de Alarcón, Madrid, Spain, 28223
Actively Recruiting
125
Hospital Vall d'Hebron
Barcelona, Spain, 08035
Actively Recruiting
126
Hospital Universitario Reina Sofia
Córdoba, Spain, 14004
Actively Recruiting
127
Hospital Universitario de la Princesa
Madrid, Spain, 28006
Actively Recruiting
128
Hospital Universitario Dr. Peset
Valencia, Spain, 46017
Actively Recruiting
129
Kaohsiung Medical University Hospital
Kaohsiung City, Taiwan, 807
Actively Recruiting
130
Taipei Medical University ?Shuang Ho Hospital
New Taipei City, Taiwan, 23561
Actively Recruiting
131
China Medical University Hospital
North Dist., Taiwan, 40447
Actively Recruiting
132
Taichung Veterans General Hospital
Taichung, Taiwan, 40705
Actively Recruiting
133
National Taiwan University Hospital
Taipei, Taiwan, 100
Actively Recruiting
134
Taipei Veterans General Hospital
Taipei, Taiwan, 11217
Actively Recruiting
135
Chang Gung Medical Foundation Linkou Branch
Taoyuan City, Taiwan, 333
Actively Recruiting
136
Lynfield Mount hospital
Bradford, United Kingdom, BD9 6DP
Actively Recruiting
137
Recognition Health Bristol
Bristol, United Kingdom, BS32 4SY
Actively Recruiting
138
Surrey and Borders NHS Foundation Trust
Chertsey, United Kingdom, KT16 9AU
Actively Recruiting
139
Department of Old Age Psychiatry Kings College
London, United Kingdom, SE5 8AF
Actively Recruiting
140
RE:Cognition Health
London, United Kingdom, W1G 8TA
Actively Recruiting
141
Charing Cross Hospital
London, United Kingdom, W6 8RF
Actively Recruiting
142
Campus for Ageing & Vitality
Newcastle, United Kingdom, NE4 5PL
Actively Recruiting
143
Tees,Esk and Wear Valleys NHS Foundation Trust
York, United Kingdom, YO31 8TA
Actively Recruiting
Research Team
R
Reference Study ID Number: WN45443 https://forpatients.roche.com/
F
Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here