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Not recruiting
Phase 3

Trontinemab

Sponsor:

Hoffmann-La Roche

Code:

NCT07170150

Conditions

Alzheimers Disease

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

Trontinemab

Placebo

Study Details

Brief summary:

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).

Conditions

Alzheimers Disease

Study ID

NCT07170150

Start date

Nov 12, 2025

Status verified date

Sep, 2026

Completion date

Feb 16, 2028

Anticipated

Primary completion date

Feb 16, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1060 participants

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Trontinemab

Participants will receive intravenous (IV) trontinemab.

placebo comparator: Placebo

Participants will receive IV placebo.

Interventions

Trontinemab

Participants will receive IV trontinemab

Placebo

Participants will receive IV placebo

Primary outcome measure

  • Change From Baseline to Week 72 in Clinical Dementia Rating, Sum of Boxes (CDR-SB) [ Time Frame: Baseline - Week 72 ]

Central Contacts and Locations

More Information

Sponsor

Hoffmann-La Roche

Last update posted

Sep 25, 2026

Last verified

Sep, 2026

Keywords

  • Early Alzheimers Disease
  • Mild Cognitive Impairment
  • Mild Dementia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-22. This information was provided to ClinicalTrials.gov by Hoffmann-La Roche on 2026-09-25. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.