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ACTIVE NOT RECRUITINGPhase3

A Study of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease

Sponsor: Hoffmann-La Roche

NCT ID: NCT07169578

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Trontinemab (drug), Placebo (other)
How long the study runs
Study runs about 29 months (dates as stated)
About the drug or intervention
Trontinemab — drug: Participants will receive IV trontinemab. · Placebo — other: Participants will receive IV placebo.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
50 Years to 90 Years
Who
All
Number of participants
1,101
Started
2025-09-17
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for alzheimers disease
  • • Phase3 - 1,101 participants
  • • The purpose of this study is to assess the efficacy and safety of trontinemab in participants with early symptomatic Alzheimer's disease (AD) (mild cognitive impairment \[MCI\] to mild dementia due to AD)

Who can take part?

  • • Ages 50 Years to 90 Years
  • • Diagnosed with alzheimers disease

Where?

  • • Bradford - Lynfield Mount hospital
  • • Bristol - Recognition Health Bristol
  • • Chertsey - Surrey and Borders NHS Foundation Trust
  • • London - Department of Old Age Psychiatry Kings College
  • • +4 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

The purpose of this study is to assess the efficacy and safety of trontinemab in participants with early symptomatic Alzheimer's disease (AD) (mild cognitive impairment \[MCI\] to mild dementia due to AD).

Alzheimers Disease

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 50 Years - 90 Years
  • Who can join: All genders

What the study is looking for

  • ✓Adequate visual and auditory acuity, in the investigator's judgment, sufficient to perform the neuropsychological...
  • ✓Evidence of AD pathological process, as confirmed on amyloid PET scan. A CSF tau181/Aβ42 ratio may be used as an...
  • ✓Probable AD dementia or MCI due to AD, also known as an Alzheimer's clinical syndrome clinical Stage 3 or Stage 4
  • ✓Screening MMSE score ≥ 22 and CDR-GS of 0.5 or 1.0
  • ✓Participant- and/or Informant-reported history of cognitive decline with gradual onset and progression over the last...

Who cannot take part

  • ✗Any evidence of a condition other than AD that may affect cognition
  • ✗History or presence of clinically significant cerebrovascular disease
  • ✗History of severe, clinically significant (persistent neurologic deficit or structural brain damage) central nervous...
  • ✗MRI evidence of significant cerebral abnormalities or inability to tolerate MRI procedures or safety concern to MRI
  • ✗History of cancer with the following exceptions: if considered to be cured; malignancies with a negligible risk...
See the full criteria
Inclusion Criteria: * Willingness and ability to complete all aspects of the study (including MRI, clinical genotyping, and PET imaging or CSF as applicable) for the duration of the study. The participant should be capable of completing assessments either alone or with the help of the study partner * Adequate visual and auditory acuity, in the investigator's judgment, sufficient to perform the neuropsychological testing (eyewear and hearing aids are permitted) * Evidence of AD pathological process, as confirmed on amyloid PET scan. A CSF tau181/Aβ42 ratio may be used as an alternative option if amyloid PET is not available * Probable AD dementia or MCI due to AD, also known as an Alzheimer's clinical syndrome clinical Stage 3 or Stage 4 * Screening MMSE score ≥ 22 and CDR-GS of 0.5 or 1.0 * Participant- and/or Informant-reported history of cognitive decline with gradual onset and progression over the last 1 year before screening * A Repeatable Battery for the Assessment of Neuropsychological Status Delayed Memory Index (RBANS DMI) score of 85 or order * Availability of a "study partner" as defined by the protocol Exclusion Criteria: * Any evidence of a condition other than AD that may affect cognition * History or presence of clinically significant cerebrovascular disease * History of severe, clinically significant (persistent neurologic deficit or structural brain damage) central nervous system (CNS) trauma * History or presence of clinically significant intracranial mass * MRI evidence of significant cerebral abnormalities or inability to tolerate MRI procedures or contraindication to MRI * Any other medical conditions (e.g., cardiovascular, hepatic, renal disease) which are not stable and adequately controlled or which in the opinion of the investigator could affect the participant's safety in the study or interfere with the study assessments * History of malignancy with the following exceptions: if considered to be cured; malignancies with a negligible risk of metastasis or death

Where Is This Study? (8 UK sites)

Lynfield Mount hospital

Bradford BD9 6DP, United Kingdom

Hospital R&D contact (matched)

Mark Dawson. Head of Research & Knowledge Services

research@bdct.nhs.uk07502579614

Recognition Health Bristol

Bristol BS32 4SY, United Kingdom

Surrey and Borders NHS Foundation Trust

Chertsey KT16 9AU, United Kingdom

Hospital R&D contact (matched)

Olga Balazikova

research@sabp.nhs.uk01372 216 584

Department of Old Age Psychiatry Kings College

London SE5 8AF, United Kingdom

Hospital R&D contact (matched)

Jasmine Palmer

kch-tr.research@nhs.net0203 299 1980

RE:Cognition Health

London W1G 8TA, United Kingdom

Charing Cross Hospital

London W6 8RF, United Kingdom

Campus for Ageing & Vitality

Newcastle NE4 5PL, United Kingdom

Tees,Esk and Wear Valleys NHS Foundation Trust

York YO31 8TA, United Kingdom

Hospital R&D contact (matched)

Research and Development TEWV

TEWV.ResearchandDevelopment@nhs.net01642 283501
Data sourced from ClinicalTrials.gov · Last verified: 2026-09