Not yet taking people in DenmarkPhase 3
Tests trontinemab against placebo in people at risk for Alzheimer's disease
Tests trontinemab against placebo in adults at risk of Alzheimer's disease.
Key facts
- Who runs it
- F. Hoffmann-La Roche AG
- Where
- Aalborg, Aarhus N, and Copenhagen Oe, DenmarkSee the 3 sitesAlso in 1 other country, 15 sites
- Trial code
- Registry title
- A study to learn about the effects of Trontinemab in participants at risk for Alzheimer‘s disease
- Status
- Not yet recruiting
- Phase
- Phase 3
- People taking part
- 119 people, planned
- Started
- 1 Sept 2026
- Expected to end
- 3 Sept 2032
- Type of study
- Interventional
- Record updated
- 1 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people with normal thinking and daily function who are at risk of developing symptomatic Alzheimer's disease. It compares trontinemab with placebo.
- Age
- The listed age range is 55 to 64 for people who need an extra risk factor; the record gives a minimum age of 18 years.
- Sex
- All sexes can join.
- Disease stage
- Thinking and daily function must be unimpaired. People with mild cognitive impairment (MCI) or any form of dementia cannot join.
Main reasons for not taking part
- Any other condition that may affect thinking, such as another type of dementia or Parkinson disease
- Mild cognitive impairment (MCI) or any form of dementia
- Serious past head or central nervous system injury with lasting problems or brain damage
- History of schizophrenia, schizoaffective disorder, major depression or bipolar disorder
- Pregnancy or breastfeeding, or planning to become pregnant during the study
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Where in Denmark
Also in 1 other country, 15 sites
- Region NordjyllandAalborg, DenmarkNot yet recruiting
- Region MidtjyllandAarhus N, DenmarkNot yet recruiting
- RigshospitaletCopenhagen Oe, DenmarkNot yet recruiting
About the trial
What the trial wants to find out
To evaluate the efficacy of trontinemab on clinical progression compared with placebo
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?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- 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
- Plain-language title
- Tests trontinemab against placebo in people at risk for Alzheimer's diseaseGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 9 November 2026.
- Record updated
- 1 October 2026