A Phase 3 interventional study of Trontinemab and Placebo in Alzheimers Disease, sponsored by Hoffmann-La Roche. Active, not recruiting at 147 sites in 16 countries. Open to participants aged 50 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Hoffmann-La Roche · Phase 3, Interventional, and Treatment
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).
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's enrollment of 1,060 is above the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive intravenous (IV) trontinemab.
Drug: Trontinemab
Participants will receive IV placebo.
Other: Placebo
Participants will receive IV trontinemab
Also known as: RO7126209
Participants will receive IV placebo
Change From Baseline to Week 72 in Clinical Dementia Rating, Sum of Boxes (CDR-SB)
Time frame: Baseline - Week 72
Change From Baseline Through Week 72 in Alzheimer's Disease Assessment Scale-Cognition 13 (ADAS-Cog-13)
Time frame: Baseline - Week 72
Change From Baseline Through Week 72 in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) Total Score and Instrumental Score
Time frame: Baseline - Week 72
Change From Baseline Through Week 72 in Integrated Alzheimer's Disease Rating Scale (iADRS)
Time frame: Baseline - Week 72
Change From Baseline Through Week 72 in Mini-Mental State Examination (MMSE)
Time frame: Baseline - Week 72
Change From Baseline in CDR-SB
Time frame: Baseline up to but excluding Week 72
Time to Increase in Clinical Dementia Rating, Global Score (CDR-GS)
Time frame: Baseline - Week 72
Percentage of Participants With Adverse Events (AEs)
Time frame: Baseline - Week 72
Change from Baseline in C-SSRS (Columbia-Suicide Severity Rating Scale)
Time frame: Baseline - Week 72
Percentage of Participants With Amyloid-related Imaging Abnormalities (ARIA) Magnetic Resonance Imaging (MRI) Findings
Time frame: Baseline - Week 72
Percentage of Participants With Infusion-related Reactions (IRR)
Time frame: Baseline - Week 72
Percentage of Participants With Anti-drug Antibodies (ADAs) to Trontinemab
Time frame: Baseline - Week 72
Change From Baseline Through Week 72 in Brain Amyloid Load as Measured by Amyloid Positron Emission Tomography (PET) Scan
Time frame: Baseline - Week 72
Change From Baseline to Week 72 in Brain tau Load as Measured by tau PET Scan in a Subset of Participants
Time frame: Baseline - Week 72
Change From Baseline Through Week 72 in Cerebrospinal Fluid (CSF) Biomarkers of Disease p-tau181, Neurogranin, Amyloid Beta (Aβ)42, Aβ42/40 in a Subset of Participants
Time frame: Baseline - Week 72
Change From Baseline Through Week 72 in Blood Biomarkers p-tau217, Glial Fibrillar Acidic Protein (GFAP), Aβ42, Aβ42/40
Time frame: Baseline - Week 72
Showing the first 100 of 147 sites across 16 countries.
Plan to share: Yes — For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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