Alzheimer's Disease / Trontinemab · Phase 3 Trial

A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease

ClinicalTrials.gov · September 10, 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 planned Phase 3 trial of trontinemab versus placebo in cognitively unimpaired individuals with biomarker evidence of Alzheimer's pathology, aiming to delay progression to symptomatic disease. The study is currently recruiting and has not yet reported results; no efficacy or safety data are available in this registry record.

What was studied

Phase 3, Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose. Alzheimer's Disease; age from 55 Years; to 80 Years. Intervention: Trontinemab. Compared with: Placebo — Placebo Comparator. n = 1,600. 7 sites across 4 countries.

Key findings

Safety

This is a registry record only; no results, efficacy data, or safety outcomes are reported. No interim analyses or preliminary efficacy/safety findings are available.

Who this may help

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

Plain-language summary

This is a clinical trial registry record with no reported results; the study is actively recruiting and designed to evaluate trontinemab in preclinical Alzheimer's disease, but outcome data are not yet available.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Time to Progression, defined as confirmed Clinical Dementia Rating - Global Score (CDR-GS) > 0 (assessed at Baseline up to approximately 6 years)

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

PopulationAlzheimer's Disease; age from 55 Years; to 80 Years

Sample size1,600

InterventionTrontinemab

ComparatorPlacebo — Placebo Comparator

Setting7 sites across 4 countries

Reported figures

Quoted from the source exactly as published.

Planned sample size1600

Primary outcome measureTime to Progression, defined as confirmed Clinical Dementia Rating - Global Score (CDR-GS) > 0

Planned follow-up durationBaseline up to approximately 6 years

Study phasePhase 3

Caveats

This is a registry record only; no results, efficacy data, or safety outcomes are reported.
Recruitment status is active; study is not yet complete.
Blinding method and allocation concealment strategy not detailed in registry record.
No interim analyses or preliminary efficacy/safety findings are available.

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 registered.

Directness

strong

Primary outcome is time to clinical progression (CDR-GS > 0), a relevant clinical endpoint.

Consistency

insufficient

Registry record only; no results reported for comparison with other evidence.

Risk of bias

insufficient

Design describes randomization and placebo control, but no detail on blinding or allocation concealment.

Sample adequacy

strong

Planned enrollment of 1600 participants is adequate for Phase 3 primary outcome detection.

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 (NCT07717411). This is a study registration, not published results. Lead sponsor: Hoffmann-La Roche. Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 1600 participants (ESTIMATED). Conditions: Alzheimer's Disease. Interventions: DRUG: Trontinemab; DRUG: Placebo. Primary outcome measures: Time to Progression, defined as confirmed Clinical Dementia Rating - Global Score (CDR-GS) > 0 , Baseline up to approximately 6 years. Brief summary: This study will evaluate the efficacy and safety of trontinemab in participants with biomarker evidence of Alzheimer's Disease (AD) pathology but with no cognitive or functional impairment, who are at risk for progression to mild cognitive impairment (MCI) due to AD or 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.

NCT07717411Alzheimer's DiseaseTrontinemabHoffmann-La Roche