A study to learn about the effects of Trontinemab in participants at risk for Alzheimer‘s disease
Key facts
- Where
- Barcelona, Donostia, Lleida, Madrid, Pamplona, Pozuelo de Alarcón, Sant Cugat del Vallès, Santander, Sevilla és Valencia, SpanyolországSee the 15 sites
- Phase
- 3. fázis
Where in Spanyolország
- Barcelonabeta Brain Research CenterBarcelona, SpanyolországToborzás még nem indult
- Fundació ACE, Institut Català de Neurociències AplicadesBarcelona, SpanyolországToborzás még nem indult
- Hospital Clinic de BarcelonaBarcelona, SpanyolországToborzás még nem indult
- Hospital de la Santa Creu i Sant PauBarcelona, SpanyolországToborzás még nem indult
- Fundacion CITA AlzheimerDonostia, SpanyolországToborzás még nem indult
- Policlinica Gipuzkoa S.A.Donostia, SpanyolországToborzás még nem indult
- Hospital Universitari de Santa MariaLleida, SpanyolországToborzás még nem indult
- Foundation for Research on Neurological Diseases (Fundacion CIEN)Madrid, SpanyolországToborzás még nem indult
- Hospital Universitario 12 de OctubreMadrid, SpanyolországToborzás még nem indult
- Clínica Universidad de navarraPamplona, SpanyolországToborzás még nem indult
- Hospital Universitario Quironsalud MadridPozuelo de Alarcón, SpanyolországToborzás még nem indult
- Hospital Universitari General de CatalunyaSant Cugat del Vallès, SpanyolországToborzás még nem indult
- Hospital Universitario Marqués de ValdecillaSantander, SpanyolországToborzás még nem indult
- University Hospital Virgen Del Rocio S.L.Sevilla, SpanyolországToborzás még nem indult
- Hospital Universitario Y Politecnico La FeValencia, SpanyolországToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- F. Hoffmann-La Roche AG
- Trial code
- EU 2025-524314-29-00
- Record updated
- 2026. október 1.
- Original description
To evaluate the efficacy of trontinemab on clinical progression compared with placeboRead full original descriptionShow less
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
To evaluate the efficacy of trontinemab on clinical progression compared with placebo
Inclusion: 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.
Exclusion: 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); Pregnancy or breastfeeding, or intending to become pregnant during the study.