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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
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

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data 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