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Trontinemab for early Alzheimer's disease (MCI to mild dementia)

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Efficacy and Safety Study of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease (MCI to Mild Dementia Due to AD)

Phase 3 Interventional Hoffmann-La Roche · NCT07169578

This trial will test whether trontinemab can slow symptoms in people with early Alzheimer's disease (from mild cognitive impairment to mild dementia).

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment800 (estimated)
Ages50 Years to 90 Years
SexAll
SponsorHoffmann-La Roche Industry-sponsored
Drugs / interventionstrontinemab
Locations141 sites (Sun City, Arizona and 140 other locations)
Trial IDNCT07169578 on ClinicalTrials.gov

What this trial studies

This is a Phase 3 interventional trial comparing trontinemab to placebo in participants with early symptomatic Alzheimer's disease. Eligible participants must have biomarker-confirmed AD pathology by amyloid PET or a CSF tau181/Aβ42 ratio and meet cognitive staging criteria (MMSE ≥ 22, CDR-GS 0.5 or 1.0). The protocol includes MRI, clinical genotyping, and PET imaging or CSF sampling, with regular clinical and cognitive assessments. Study sites are located in Arizona and California.

Who should consider this trial

Good fit: Ideal candidates are people with early symptomatic AD (MCI to mild dementia) who have amyloid-positive PET or qualifying CSF biomarkers, MMSE ≥ 22, CDR-GS 0.5 or 1.0, and who can undergo MRI, PET or CSF procedures and travel to a study site.

Not a fit: People with moderate-to-severe Alzheimer’s disease, without biomarker evidence of amyloid pathology, or who cannot undergo required imaging/CSF procedures are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, trontinemab could slow cognitive decline and delay progression from mild impairment to greater dementia.

How similar studies have performed: Other anti-amyloid antibody programs have shown mixed results, with some recent agents demonstrating modest slowing of decline but ongoing questions about clinical impact and safety.

Eligibility criteria

Show full inclusion / exclusion 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 this trial is running

Sun City, Arizona and 140 other locations

+91 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Alzheimers DiseaseEarly Alzheimers DiseaseMild Cognitive ImpairmentMild Dementia
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.