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

Study acronym: TRONTIER 2
StatusActive, Not Recruiting
PhasePhase 3
Started2025-11-12
View on ClinicalTrials.gov ↗

Amendment history

2026-09-26
Enrollment closed, study ongoing
Final enrollment: 1060 participants (planned 800)
Trial sites reduced: 150 → 147 locations
Primary completion moved earlier: 2028-06-07 → 2028-02-16
Completion moved earlier: 2028-06-07 → 2028-02-16
2026-08-04
Study Status, Contacts/Locations v13
Study sitesdetails revised at 25 of 150 sites
2026-07-03
Study Status, Contacts/Locations v12
Study sites150 entries, revised
Chonnam National University Hwasun Hospital
2026-06-05
Study Status, Contacts/Locations, References v11
Study sites150 entries, revised
Chonnam National University Hwasun Hospital
2026-05-08
Study Status, Contacts/Locations v10
Trial sites expanded: 146 → 150 locations
2026-04-10
Study Status, Contacts/Locations v9
Trial sites expanded: 135 → 146 locations
2026-03-12
Study Status, Contacts/Locations v8
Study sites122→135
2026-02-13
Study Status, Contacts/Locations v7
Study sites104→122
2026-01-16
Study Status, Contacts/Locations v6
Study sites74→104
2025-12-17
Study Status, Contacts/Locations v5
Study sites47→74
2025-11-21
Study Status, Contacts/Locations v4
Study sites41→47
2025-11-20
Study Status, Contacts/Locations v3
Primary completion date2028-07-25→2028-06-07
Completion date2028-11-07→2028-06-07
Start dateestimated 2025-10-27→confirmed 2025-11-12
Study sites21→41
2025-10-23
Study Status, Contacts/Locations v2
Study sites6→21
2025-09-26
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Study sites0→6
2025-09-10
Original filing
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).
Trial Details
NCT Number NCT07170150
Lead Sponsor Hoffmann-La Roche
Conditions Alzheimers Disease
Enrollment 1,060 participants
Start Date 2025-11-12
Primary Completion 2028-02-16 (estimated)
Study Completion 2028-02-16 (estimated)
Updated on ClinicalTrials.gov 2026-09-25