Back to search results

Trontinemab for Early Symptomatic Alzheimer's Disease

This study is testing a drug called trontinemab to see if it is safe and effective for people with early symptomatic Alzheimer's disease (AD), which includes mild cognitive impairment (MCI) to mild dementia due to AD. Participants will receive either trontinemab or a placebo (an inactive substance) through an IV. Researchers will measure changes in your thinking and daily function using a scale called the Clinical Dementia Rating, Sum of Boxes (CDR-SB) over 72 weeks to see if trontinemab helps. You may be able to join if you are between 50 and 90 years old and can complete study activities, including MRI and other imaging or fluid tests. The study status is currently unclear, and it plans to enroll about 800 people.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It involves about 800 participants and compares trontinemab to a placebo.
What's involved
You would need to complete all aspects of the study, including MRI, clinical genotyping, and PET imaging or CSF (spinal fluid) tests. These assessments will occur over 72 weeks.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured from baseline to Week 72, indicating participants will be followed for at least 72 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07170150

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

Recruiting
PHASE3Ages 50–90InterventionalTreatment
Hoffmann-La Roche
~800 participants
Updated 2026-08-06 on ClinicalTrials.gov
What's tested:TrontinemabPlacebo

At a glance

Recruiting sites
110 of 150 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from baseline to Week 72 in Clinical Dementia Rating, Sum of Boxes (CDR-SB)
Measured over Baseline - Week 72

Conditions

Alzheimers Disease

Explore related trials

Alzheimer's DiseaseMild cognitive disorderMild dementiaAmyloidTau181/Aβ42

Where it's being run

150 sites across 48 states
Germany14
South Korea12
Poland11
United Kingdom11
Japan10
France9
Spain7
Florida6

Study leadership

  • Clinical Trials · STUDY_DIRECTOR · Hoffmann-La Roche

Who to contact

Reference Study ID Number: WN45447 https://forpatients.roche.com/ No attachments to email below.
[email protected]
888-662-6728
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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

What this trial measures

  • Change from baseline to Week 72 in Clinical Dementia Rating, Sum of Boxes (CDR-SB)Baseline - Week 72