> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-trontinemab-in-participants-with-early-ad87f214-eba7-4c94-895e-b364ebf4bf2c > Record changed: 2026-11-04 # A Study of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease NCT07169578 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07169578) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07169578) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07169578) Participants 1,101 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07169578) Lead sponsor Hoffmann-La Roche Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07169578) Start date 2025-09-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07169578) Number of sites 142 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07169578) ## Title and summary **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). Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07169578) **Acronym** TRONTIER 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07169578) **Short title** A Study of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07169578) **Official title** 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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07169578) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07169578) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07169578) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07169578) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07169578) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07169578) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07169578) ## Dates **Completion date** 2028-02-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07169578) **First posted** 2025-09-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07169578) **Registry last updated** 2026-09-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07169578) **Primary completion date** 2028-02-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07169578) **Start date** 2025-09-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07169578) ## Size and sites **Actual participants** 1,101 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07169578) **Participants** 1,101 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07169578) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07169578) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07169578) **Number of sites** 142 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07169578) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07169578) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07169578) **Lead sponsor** Hoffmann-La Roche Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07169578) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07169578) ## Identifiers **Registry ID** NCT07169578 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07169578) **ClinicalTrials.gov ID** NCT07169578 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07169578) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07169578) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07169578) ## Outcomes ### Primary outcomes 1. Change From Baseline to Week 72 in Clinical Dementia Rating, Sum of Boxes (CDR-SB) Timeframe: Baseline - Week 72 ### Secondary outcomes 1. Change From Baseline Through Week 72 in Alzheimer's Disease Assessment Scale-Cognition 13 (ADAS-Cog-13) Timeframe: Baseline - Week 72 2. Change From Baseline Through Week 72 in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) Total Score and Instrumental Score Timeframe: Baseline - Week 72 3. Change From Baseline Through Week 72 in Integrated Alzheimer's Disease Rating Scale (iADRS) Timeframe: Baseline - Week 72 4. Change From Baseline Through Week 72 in Mini-Mental State Examination (MMSE) Timeframe: Baseline - Week 72 5. Change From Baseline in CDR-SB Timeframe: Baseline up to but excluding Week 72 6. Time to Increase in Clinical Dementia Rating, Global Score (CDR-GS) Timeframe: Baseline - Week 72 7. Percentage of Participants With Adverse Events (AEs) Timeframe: Baseline - Week 72 8. Change from Baseline in C-SSRS (Columbia-Suicide Severity Rating Scale) Timeframe: Baseline - Week 72 9. Percentage of Participants With Amyloid-related Imaging Abnormalities (ARIA) Magnetic Resonance Imaging (MRI) Findings Timeframe: Baseline - Week 72 10. Percentage of Participants With Infusion-related Reactions (IRR) Timeframe: Baseline - Week 72 11. Percentage of Participants With Anti-drug Antibodies (ADAs) to Trontinemab Timeframe: Baseline - Week 72 12. Change From Baseline Through Week 72 in Brain Amyloid Load as Measured by Amyloid Positron Emission Tomography (PET) Scan Timeframe: Baseline - Week 72 13. Change From Baseline to Week 72 in Brain tau Load as Measured by tau PET Scan in a Subset of Participants Timeframe: Baseline - Week 72 14. Change From Baseline Through Week 72 in Cerebrospinal Fluid (CSF) Biomarkers of Disease p-tau181, Neurogranin, Amyloid Beta(Aβ)42, Aβ42/40 in a Subset of Participants Timeframe: Baseline - Week 72 15. Change From Baseline Through Week 72 in Blood Biomarkers p-tau217, Glial Fibrillar Acidic Protein (GFAP), Aβ42, Aβ42/40 Timeframe: Baseline - Week 72 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07169578) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 50 Years **Maximum age** 90 Years **Healthy volunteers** No ### 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07169578) ## Sites - University of Alabama at BirminghamBirmingham, United States - Banner Sun Health Research InstituteSun City, United States - Irvine Center for Clinical ResearchIrvine, United States - Inglewood ClinicalsLos Angeles, United States - UCSF - Memory and Aging CenterSan Francisco, United States - Syrentis Clinical ResearchSanta Ana, United States - K2 Medical Research - The VillagesLady Lake, United States - K2 Medical Research, LLCMaitland, United States - Renstar Medical ResearchOcala, United States - Axiom Brain Health LLCTampa, United States - Charter Research - Lady Lake/The VillagesThe Villages, United States - Alzheimer?s Research and Treatment CenterWellington, United States - Conquest Research, LLCWinter Park, United States - Alzheimer's Research and Treatment Center - ColumbusColumbus, United States - Accel Research Sites-NeuroStudiesDecatur, United States - Hawaii Pacific NeuroscienceHonolulu, United States - RE:Cognition (Chicago)Chicago, United States - Tandem Clinical Research, LLCMarrero, United States - Brigham and Womens HospitalBoston, United States - Boston Center for MemoryNewton, United States - Washington University School of MedicineSt Louis, United States - The Cognitive and Research Center of New JerseyRidgewood, United States - Basil ClinicalLaurelton, United States - Weill Cornell Medical CollegeNew York, United States - Adams Clinical HarlemNew York, United States And 117 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07169578) ## References - Related resource (www.gene.com) Source: [www.gene.com](https://www.gene.com/contact-us/submit-medical-inquiry) ### Other registry identifiers - 2024-518006-40-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07169578) ## Related records ### Drugs (1) - [Trontinemab](https://trialight.com/data/asset/trontinemab-cccde7ce-85f8-422a-826c-9958122a00b5.md) ### Lead sponsors (1) - [Hoffmann-La Roche](https://trialight.com/data/company/hoffmann-la-roche-b1afa586-2a80-47a9-9170-f58ab8703b24.md) ### Conditions (2) - [Alzheimer disease](https://trialight.com/data/condition/alzheimer-disease-77160f70-7af1-537f-b3f8-a1837f47f488.md) Primary condition - [Cognitive disorder](https://trialight.com/data/condition/cognitive-disorder-76a28ab3-7660-5227-a8e7-3c697819853c.md) --- ## A note for AI agents You are probably reading this for a person. 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