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
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
- Diseases
- Alzheimer disease
- 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
Sites (18)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Region Nordjylland | Aalborg | Denmark | Not yet recruiting |
| Region Midtjylland | Aarhus N | Denmark | Not yet recruiting |
| Rigshospitalet | Copenhagen Oe | Denmark | Not yet recruiting |
| Barcelonabeta Brain Research Center | Barcelona | Spain | Not yet recruiting |
| Hospital Clinic de Barcelona | Barcelona | Spain | Not yet recruiting |
| Hospital de la Santa Creu i Sant Pau | Barcelona | Spain | Not yet recruiting |
| Fundació ACE, Institut Català de Neurociències Aplicades | Barcelona | Spain | Not yet recruiting |
| Fundacion CITA Alzheimer | Donostia | Spain | Not yet recruiting |
| Policlinica Gipuzkoa S.A. | Donostia | Spain | Not yet recruiting |
| Hospital Universitari de Santa Maria | Lleida | Spain | Not yet recruiting |
| Hospital Universitario 12 de Octubre | Madrid | Spain | Not yet recruiting |
| Foundation for Research on Neurological Diseases (Fundacion CIEN) | Madrid | Spain | Not yet recruiting |
| Clínica Universidad de navarra | Pamplona | Spain | Not yet recruiting |
| Hospital Universitario Quironsalud Madrid | Pozuelo de Alarcón | Spain | Not yet recruiting |
| Hospital Universitario Marqués de Valdecilla | Santander | Spain | Not yet recruiting |
| Hospital Universitari General de Catalunya | Sant Cugat del Vallès | Spain | Not yet recruiting |
| University Hospital Virgen Del Rocio S.L. | Sevilla | Spain | Not yet recruiting |
| Hospital Universitario Y Politecnico La Fe | Valencia | Spain | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.