NCT07170150 A Clinical Trial of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease
| NCT ID | NCT07170150 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Hoffmann-La Roche |
| Condition | Alzheimers Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 800 participants |
| Start Date | 2025-11-12 |
| Primary Completion | 2028-06-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 800 participants in total. It began in 2025-11-12 with a primary completion date of 2028-06-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility 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
Contact & Investigator
Reference Study ID Number: WN45447 https://forpatients.roche.com/ No attachments to email below.
✉ global-roche-genentech-trials@gene.com📞 888-662-6728
Clinical Trials
STUDY DIRECTOR
Hoffmann-La Roche
Frequently Asked Questions
Who can join the NCT07170150 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 90 Years, studying Alzheimers Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07170150 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 800 participants.
Is NCT07170150 currently recruiting?
Yes, NCT07170150 is actively recruiting participants. Contact the research team at global-roche-genentech-trials@gene.com for enrollment information.
Where is the NCT07170150 trial being conducted?
This trial is being conducted at Phoenix, United States, Imperial, United States, Long Beach, United States, Oakland, United States and 11 additional locations.
Who is sponsoring the NCT07170150 clinical trial?
NCT07170150 is sponsored by Hoffmann-La Roche. The principal investigator is Clinical Trials at Hoffmann-La Roche. The trial plans to enroll 800 participants.
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