Alzheimers Disease / Trontinemab · Phase 3 Trial

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

ClinicalTrials.gov · August 6, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a registry record for an ongoing Phase 3 randomized controlled trial of trontinemab in early symptomatic Alzheimer's disease that is currently recruiting participants. No efficacy or safety results are posted in this registry record, so clinical utility cannot yet be assessed.

What was studied

Phase 3, Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose. Alzheimers Disease; age from 50 Years; to 90 Years. Intervention: Trontinemab. Compared with: Placebo — Placebo Comparator. n = 800. 143 sites across 13 countries.

Key findings

Safety

This is a registry record only; no efficacy or safety results are reported

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a registry record of an ongoing Phase 3 trial with no results posted; the study is recruiting and outcomes have not yet been reported.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Change from baseline to Week 72 in Clinical Dementia Rating, Sum of Boxes (CDR-SB) (assessed at Baseline - Week 72)

DesignPhase 3, Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose

PopulationAlzheimers Disease; age from 50 Years; to 90 Years

Sample size800

InterventionTrontinemab

ComparatorPlacebo — Placebo Comparator

Setting143 sites across 13 countries

Reported figures

Quoted from the source exactly as published.

Planned enrollment800

PhasePhase 3

Primary outcome measureChange from baseline to Week 72 in Clinical Dementia Rating, Sum of Boxes (CDR-SB)

Study durationWeek 72

Caveats

This is a registry record only; no efficacy or safety results are reported
Study recruitment is ongoing; no primary outcome data available
Blinding status, randomization methodology, and risk of bias details are not provided in registry record
Follow-up duration and analysis plan details are not specified in this registry entry

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

strong

Phase 3 randomized controlled trial with placebo comparator

Directness

strong

Primary outcome is CDR-SB, a direct clinical measure in target population

Consistency

insufficient

No results reported; consistency cannot be assessed from registry record alone

Risk of bias

insufficient

Methodologic details and conduct not described in registry record

Sample adequacy

strong

Estimated enrollment 800 participants appropriate for Phase 3 AD trial

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07169578). This is a study registration, not published results. Lead sponsor: Hoffmann-La Roche. Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 800 participants (ESTIMATED). Conditions: Alzheimers Disease. Interventions: DRUG: Trontinemab; OTHER: Placebo. Primary outcome measures: Change from baseline to Week 72 in Clinical Dementia Rating, Sum of Boxes (CDR-SB) , Baseline - Week 72. Brief summary: 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).

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

NCT07169578Alzheimers DiseaseTrontinemabHoffmann-La Roche