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A Study of Trontinemab for Early 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). This includes individuals with mild cognitive impairment (MCI) or mild dementia due to AD. Some participants will receive trontinemab through an IV, while others will receive a placebo (an inactive substance). The main goal is to see how much a person's thinking and daily function changes over 72 weeks, using a tool called the Clinical Dementia Rating, Sum of Boxes (CDR-SB). The study plans to enroll about 800 participants between 50 and 90 years old. The current status of the study is unclear.

Study design
This interventional study plans to enroll 800 participants. Some will receive trontinemab and others a placebo.
What's involved
You would need to be willing and able to complete all study aspects, including MRI, genetic testing, and PET imaging or spinal fluid tests, for the duration of the study. You should also be able to complete assessments, possibly with help from a study partner.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured up to Week 72.

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

NCT07169578

A Study 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 143 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

143 sites across 43 states
China23
Germany13
Japan11
France9
Poland9
United Kingdom8
Florida7
Taiwan7

Study leadership

  • Clinical Trials · STUDY_DIRECTOR · Hoffmann-La Roche

Who to contact

Reference Study ID Number: WN45443 https://forpatients.roche.com/ No attachments to email below.
[email protected]
888-662-6728
Email the study team

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Do you actually qualify for this trial?

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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