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

Study acronym: TRONTIER 1
StatusActive, Not Recruiting
PhasePhase 3
Started2025-09-17
View on ClinicalTrials.gov ↗

Amendment history

2026-09-26
Enrollment closed, study ongoing
Final enrollment: 1101 participants (planned 800)
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 v11
Study sitesdetails revised at 23 of 143 sites
2026-07-01
Study Status, Contacts/Locations v10
Study sitesdetails revised at 10 of 143 sites
2026-06-01
Study Status, Contacts/Locations, References v9
Study sites141→143
2026-05-01
Study Status, Contacts/Locations v8
Trial sites expanded: 134 → 141 locations
2026-04-02
Study Status, Contacts/Locations v7
Trial sites expanded: 120 → 134 locations
2026-03-04
Study Status, Contacts/Locations v6
Study sites108→120
2026-02-04
Study Status, Contacts/Locations v5
Study sites91→108
2026-01-05
Study Status, Contacts/Locations v4
Study sites69→91
2025-12-04
Study Status, Contacts/Locations v3
Study sites29→69
2025-11-06
Study Status, Contacts/Locations v2
Study sites11→29
2025-10-09
Study Status, Contacts/Locations v1
Primary completion date2028-07-25→2028-06-07
Completion date2028-11-07→2028-06-07
Start dateestimated 2025-10-27→confirmed 2025-09-17
Study sites3→11
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 NCT07169578
Lead Sponsor Hoffmann-La Roche
Conditions Alzheimers Disease
Enrollment 1,101 participants
Start Date 2025-09-17
Primary Completion 2028-02-16 (estimated)
Study Completion 2028-02-16 (estimated)
Updated on ClinicalTrials.gov 2026-09-25