Ignite Creation Date:
2025-12-24 @ 5:07 PM
Ignite Modification Date:
2025-12-29 @ 1:27 PM
Study NCT ID:
NCT07170150
Status:
RECRUITING
Last Update Posted:
2025-12-18
First Post:
2025-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Trial of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003072', 'term': 'Cognition Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-06-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-17', 'studyFirstSubmitDate': '2025-09-10', 'studyFirstSubmitQcDate': '2025-09-10', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-06-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline to Week 72 in Clinical Dementia Rating, Sum of Boxes (CDR-SB)', 'timeFrame': 'Baseline - Week 72'}], 'secondaryOutcomes': [{'measure': "Change from baseline through Week 72 in Alzheimer's Disease Assessment Scale-Cognition 13 (ADAS-Cog-13)", 'timeFrame': 'Baseline - Week 72'}, {'measure': "Change from baseline through Week 72 in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) total score and instrumental score", 'timeFrame': 'Baseline - Week 72'}, {'measure': "Change from baseline through Week 72 in Integrated Alzheimer's Disease Rating Scale (iADRS)", 'timeFrame': 'Baseline - Week 72'}, {'measure': 'Change from baseline through Week 72 in Mini-Mental State Examination (MMSE)', 'timeFrame': 'Baseline - Week 72'}, {'measure': 'Change from baseline in CDR-SB', 'timeFrame': 'Baseline up to but excluding Week 72'}, {'measure': 'Time to increase in Clinical Dementia Rating, Global Score (CDR-GS)', 'timeFrame': 'Baseline - Week 72'}, {'measure': 'Percentage of participants with adverse events (AEs)', 'timeFrame': 'Baseline - Week 72'}, {'measure': 'Percentage of participants with amyloid-related imaging abnormalities (ARIA) magnetic resonance imaging (MRI) findings', 'timeFrame': 'Baseline - Week 72'}, {'measure': 'Percentage of participants with infusion-related reactions (IRR)', 'timeFrame': 'Baseline - Week 72'}, {'measure': 'Percentage of participants with anti-drug antibodies (ADAs) to trontinemab', 'timeFrame': 'Baseline - Week 72'}, {'measure': 'Change from baseline through Week 72 in brain amyloid load as measured by amyloid positron emission tomography (PET) scan', 'timeFrame': 'Baseline - Week 72'}, {'measure': 'Change from baseline to Week 72 in brain tau load as measured by tau PET scan in a subset of participants', 'timeFrame': 'Baseline - Week 72'}, {'measure': 'Change from baseline through Week 72 in cerebrospinal fluid (CSF) biomarkers of disease p-tau181, neurogranin, Aβ42 in a subset of participants', 'timeFrame': 'Baseline - Week 72'}, {'measure': 'Change from baseline through Week 72 in blood biomarkers p-tau217, glial fibrillar acidic protein (GFAP)', 'timeFrame': 'Baseline - Week 72'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Early Alzheimers Disease', 'Mild Cognitive Impairment', 'Mild Dementia'], 'conditions': ['Alzheimers Disease']}, 'descriptionModule': {'briefSummary': "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)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\n* Adequate visual and auditory acuity, in the investigator\'s judgment, sufficient to perform the neuropsychological testing (eyewear and hearing aids are permitted)\n* 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\n* Probable AD dementia or MCI due to AD, also known as an Alzheimer\'s clinical syndrome clinical Stage 3 or Stage 4\n* Screening MMSE score ≥ 22 and CDR-GS of 0.5 or 1.0\n* Participant- and/or Informant-reported history of cognitive decline with gradual onset and progression over the last 1 year before screening\n* A Repeatable Battery for the Assessment of Neuropsychological Status Delayed Memory Index (RBANS DMI) score of 85 or order\n* Availability of a "study partner" as defined by the protocol\n\nExclusion Criteria:\n\n* Any evidence of a condition other than AD that may affect cognition\n* History or presence of clinically significant cerebrovascular disease\n* History of severe, clinically significant (persistent neurologic deficit or structural brain damage) central nervous system (CNS) trauma\n* History or presence of clinically significant intracranial mass\n* MRI evidence of significant cerebral abnormalities or inability to tolerate MRI procedures or contraindication to MRI\n* 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\n* History of malignancy with the following exceptions: if considered to be cured; malignancies with a negligible risk of metastasis or death'}, 'identificationModule': {'nctId': 'NCT07170150', 'acronym': 'TRONTIER 2', 'briefTitle': "A Clinical Trial of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': "A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Efficacy and Safety Study of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease (MCI to Mild Dementia Due to AD)", 'orgStudyIdInfo': {'id': 'WN45447'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Trontinemab', 'description': 'Participants will receive intravenous (IV) trontinemab.', 'interventionNames': ['Drug: Trontinemab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will receive IV placebo.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Trontinemab', 'type': 'DRUG', 'otherNames': ['RO7126209'], 'description': 'Participants will receive IV trontinemab', 'armGroupLabels': ['Trontinemab']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Participants will receive IV placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90804', 'city': 'Long Beach', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Healthy Brain Clinic', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '94609', 'city': 'Oakland', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Oakland Clinical', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '92506', 'city': 'Riverside', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Riverside Clinical', 'geoPoint': {'lat': 33.95335, 'lon': -117.39616}}, {'zip': '91403', 'city': 'Sherman Oaks', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Cenexel California Neuroscience Research, LLC', 'geoPoint': {'lat': 34.15112, 'lon': -118.44925}}, {'zip': '33462', 'city': 'Atlantis', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'JEM Research LLC', 'geoPoint': {'lat': 26.5909, 'lon': -80.10088}}, {'zip': '34711', 'city': 'Clermont', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'K2 Medical Research-Winter Garden', 'geoPoint': {'lat': 28.54944, 'lon': -81.77285}}, {'zip': '33133', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Visionary Investigators Network- Neurology Aventura', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Charter Research - Winter Park/Orlando', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '32832', 'city': 'Orlando', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Conquest Research - Lake Nona', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '34997', 'city': 'Stuart', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': "Alzheimer's Research and Treatment Center", 'geoPoint': {'lat': 27.19755, 'lon': -80.25283}}, {'zip': '30030', 'city': 'Decatur', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'CenExel iResearch, LLC', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}, {'zip': '30501', 'city': 'Gainesville', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Center for Advanced Research & Education', 'geoPoint': {'lat': 34.29788, 'lon': -83.82407}}, {'zip': '02472', 'city': 'Watertown', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Adams Clinical Watertown', 'geoPoint': {'lat': 42.37093, 'lon': -71.18283}}, {'zip': '48334', 'city': 'Farmington Hills', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Quest Research Institute', 'geoPoint': {'lat': 42.48531, 'lon': -83.37716}}, {'zip': '07081', 'city': 'Springfield', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'The Cognitive and Research Center of New Jersey', 'geoPoint': {'lat': 40.70491, 'lon': -74.31723}}, {'zip': '97210', 'city': 'Portland', 'state': 'Oregon', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Summit Research Network Inc.', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19462', 'city': 'Plymouth Meeting', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Flourish Research ? 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