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Trontinemab

Phase 3

Alzheimer's Disease | Small molecule | Neurology |Roche Holding AG|Last Updated: Aug 6, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment1,600

FDA Designations

No designations recorded

Clinical trial landscape

Trontinemab · 3 trials · 2 indications

Phase 3 3
NCT07717411A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's DiseaseAlzheimer's Disease
NOT YET_RECRUITING1,600 Analytics
NCT07170150A Clinical Trial of Trontinemab in Participants With Early Symptomatic Alzheimer's DiseaseAlzheimers Disease
RECRUITING800 Analytics
NCT07169578A Study of Trontinemab in Participants With Early Symptomatic Alzheimer's DiseaseAlzheimers Disease
RECRUITING800 Analytics
PHASE3NOT YET_RECRUITING
A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease
Alzheimer's DiseaseUnlock trial analytics
PHASE3RECRUITING
A Clinical Trial of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease
Alzheimers DiseaseUnlock trial analytics
PHASE3RECRUITING
A Study of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease
Alzheimers DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Time to Progression, defined as confirmed Clinical Dementia Rating - Global Score (CDR-GS) > 0
Baseline up to approximately 6 years
Change from baseline to Week 72 in Clinical Dementia Rating, Sum of Boxes (CDR-SB)
Baseline - Week 72

Secondary Endpoints

Change from Baseline through Week 216 in Clinical Dementia Rating, Sum of Boxes (CDR-SB)
Baseline through Week 216
Change from Baseline through Week 216 in Free and Cued Selective Reminding Test (FCSRT) total recall score
Baseline through Week 216
Change from Baseline through Week 216 in Digit Symbol Substitution Test (DSST) coding score
Baseline through Week 216
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
TrontinemabEXPERIMENTALParticipants will receive intravenous (IV) trontinemab.
PlaceboPLACEBO_COMPARATORParticipants will receive IV placebo.

Interventions

NameTypeDescription
TrontinemabDRUGParticipants will receive IV trontinemab.
PlaceboDRUGParticipants will receive IV placebo.
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Eligibility Criteria

Age Range55 Years to 80 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Body weight of 150 kg or less * Willingness and ability to complete all aspects of the study for the duration of the study * Adequate visual and auditory acuity, in the investigator's judgment, sufficient to perform the neuropsychological testing (eyewear and hearing aids are ...

Countries:United StatesArgentinaAustraliaBrazilCanadaDenmarkFranceGermanyItalyJapanNetherlandsPolandSouth KoreaSpainSwitzerlandUnited KingdomChinaTaiwan
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Recent Changes (Last 90 Days)

LOWAug 6, 2026NCT07169578lastUpdatePostDate: changed
LOWAug 6, 2026NCT07170150lastUpdatePostDate: changed
LOWAug 6, 2026NCT07169578lastUpdatePostDate: changed
LOWAug 6, 2026NCT07170150lastUpdatePostDate: changed

Frequently asked questions about Trontinemab

What is Trontinemab used for?

Trontinemab is an investigational antibody being developed for Alzheimer's disease. It is studied in participants with early symptomatic Alzheimer's disease and in cognitively unimpaired individuals at risk for progression to symptomatic Alzheimer's disease. The drug is in Phase 3 clinical development.

What does Trontinemab target?

Trontinemab is a monoclonal antibody, indicated by the '-mab' suffix in its name. It is being studied for its effects in Alzheimer's disease, a neurological condition. The specific molecular target of Trontinemab is not disclosed in the available clinical trial information.

Who is developing Trontinemab?

Trontinemab is being developed by Roche Holding AG, a company traded under the ticker RHHBY. Roche is conducting Phase 3 clinical trials to evaluate the drug in Alzheimer's disease populations.

What phase is Trontinemab in?

Trontinemab is in Phase 3 clinical development. There are multiple Phase 3 trials listed as recruiting or not yet recruiting. Trontinemab is investigational and has not been approved by regulatory authorities.

What clinical trials is Trontinemab in?

Trontinemab is being studied in three Phase 3 trials. NCT07169578 and NCT07170150 are recruiting participants with early symptomatic Alzheimer's disease, each with 800 participants. NCT07717411 is not yet recruiting and targets cognitively unimpaired individuals at risk for Alzheimer's disease, with 1,600 participants.

Is Trontinemab the same as other Alzheimer's antibodies?

Trontinemab is a distinct monoclonal antibody developed by Roche. It is not identified as being the same as any other named drug in the available information. Its development program focuses on early symptomatic Alzheimer's disease and prevention in at-risk individuals.