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2025-524314-29-00Not yet recruitingPhase 3

A study to learn about the effects of Trontinemab in participants at risk for Alzheimer‘s disease

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Efficacy and Safety Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer’s Disease

Source: EU CTIS (euclinicaltrials.eu) · Last updated 1 Oct 2026

Next steps

Brief summary (registry, in English)

To evaluate the efficacy of trontinemab on clinical progression compared with placebo

Status (registry)
Not yet recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
119 (estimated)
First submitted
15 Jun 2026
Start date
1 Sept 2026
Lead sponsor
F. Hoffmann-La Roche AG
EU CT number
2025-524314-29-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 119
  • 18 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Any evidence of a condition other than AD that may affect cognition, including, but not limited to, frontotemporal dementia, dementia with Lewy bodies, vascular dementia, Parkinson disease, corticobasal syndrome, Creutzfeldt-Jakob disease, progressive supranuclear palsy, frontotemporal lobar degeneration (other than frontotemporal dementia), Huntington disease, normal pressure hydrocephalus, seizure disorder, delirium, or hypoxia
  • MCI (may be referred to as prodromal AD), or any form of dementia
  • History of severe, clinically significant (persistent neurologic deficit or structural brain damage) central nervous system (CNS) trauma
  • History of schizophrenia, schizoaffective disorder, major depression, or bipolar disorder
  • Uncontrolled hypertension (e.g., blood pressure generally >160 mmHg systolic or > 95 mmHg diastolic)

Other

  • Pregnancy or breastfeeding, or intending to become pregnant during the study

Who the study is looking for

  • Individuals aged ≥ 55 to ≤ 64 must have at least one of the following additional risk factors prior to screening: – First degree relative diagnosed with dementia onset before age 75
  • Body weight of 150 kg or less
  • Adequate visual and auditory acuity, in the investigator’s judgment, sufficient to perform the neuropsychological testing (eyewear and hearing aids are permitted)
  • Cognitively and functionally unimpaired
  • Agreement to adhere to the contraception requirements (highly effective methods for female participants <1% error rate)
  • Agreement not to donate blood or blood products for transfusion for the duration of the study and for 1 year after final dose of study drug

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (18)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Region NordjyllandAalborgDenmarkNot yet recruiting
Region MidtjyllandAarhus NDenmarkNot yet recruiting
RigshospitaletCopenhagen OeDenmarkNot yet recruiting
Barcelonabeta Brain Research CenterBarcelonaSpainNot yet recruiting
Hospital Clinic de BarcelonaBarcelonaSpainNot yet recruiting
Hospital de la Santa Creu i Sant PauBarcelonaSpainNot yet recruiting
Fundació ACE, Institut Català de Neurociències AplicadesBarcelonaSpainNot yet recruiting
Fundacion CITA AlzheimerDonostiaSpainNot yet recruiting
Policlinica Gipuzkoa S.A.DonostiaSpainNot yet recruiting
Hospital Universitari de Santa MariaLleidaSpainNot yet recruiting
Hospital Universitario 12 de OctubreMadridSpainNot yet recruiting
Foundation for Research on Neurological Diseases (Fundacion CIEN)MadridSpainNot yet recruiting
Clínica Universidad de navarraPamplonaSpainNot yet recruiting
Hospital Universitario Quironsalud MadridPozuelo de AlarcónSpainNot yet recruiting
Hospital Universitario Marqués de ValdecillaSantanderSpainNot yet recruiting
Hospital Universitari General de CatalunyaSant Cugat del VallèsSpainNot yet recruiting
University Hospital Virgen Del Rocio S.L.SevillaSpainNot yet recruiting
Hospital Universitario Y Politecnico La FeValenciaSpainNot yet recruiting

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This page is information, not medical advice. Discuss any trial with your doctor.