A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease

NCT07717411 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: WN46072
• Study Type: interventional
• Target: 1,600
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will evaluate the efficacy and safety of trontinemab in participants with biomarker evidence of Alzheimer's Disease (AD) pathology but with no cognitive or functional impairment, who are at risk for progression to mild cognitive impairment (MCI) due to AD or dementia due to AD.

Conditions

Alzheimer's Disease

Keywords

Alzheimer's; Alzheimer's Disease; pre-clinical

Outcome Measures

Primary Outcomes (1)

• Time to Progression, defined as confirmed Clinical Dementia Rating - Global Score (CDR-GS) > 0

  Baseline up to approximately 6 years

Secondary Outcomes (19)

• 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

• Change from Baseline through Week 216 in Cognitive Function Instrument (CFI) study partner, total score

  Baseline through Week 216

• Change from Baseline through Week 216 in Category fluency total score

  Baseline through Week 216

Study Arms (2)

Trontinemab

EXPERIMENTAL

Participants will receive intravenous (IV) trontinemab.

Drug: Trontinemab

Placebo

PLACEBO COMPARATOR

Participants will receive IV placebo.

Drug: Placebo

Interventions

Trontinemab DRUG

Participants will receive IV trontinemab.

Trontinemab

Placebo DRUG

Participants will receive IV placebo.

Placebo

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 permitted)
• Cognitively and functionally unimpaired as defined by the protocol
• Availability of a study partner as defined by the protocol
• A plasma pTau217 level consistent with a high likelihood of future clinical progression

You may not qualify if:

• Any evidence of a condition other than AD that may affect cognition, including, but not limited to, frontotemporal dementia, dementia with Lewy bodies, vascular dementia, Parkinson disease, corticobasal syndrome, Creutzfeldt-Jakob disease, progressive supranuclear palsy, frontotemporal lobar degeneration (other than frontotemporal dementia), Huntington disease, normal pressure hydrocephalus, seizure disorder, delirium, or hypoxia
• Mild cognitive impairment (MCI; may be referred to as prodromal AD), or any form of dementia
• 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
• History of schizophrenia, schizoaffective disorder, major depression, or bipolar disorder
• History or presence of any stroke with clinical symptoms within the past 12 months, or documented history within the last 12 months of an acute event that is consistent, in the opinion of the PI, with a transient ischemic attack
• At risk for suicide in the opinion of the investigator
• Substance abuse disorder within 12 months prior to screening (nicotine use is allowed)
• 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
• Uncontrolled hypertension
• Impaired hepatic function
• History or presence of any clinically significant hematological diseases
• Diagnosis of a wet age-related macular degeneration (AMD)
• Abnormal thyroid function

Sponsors & Collaborators

• Hoffmann-La Roche: lead

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Central Study Contacts

Reference Study ID Number: WN46072 https://forpatients.roche.com

CONTACT

1-888-662-6728; global-roche-genentech-trials@gene.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2026
• First Posted: July 21, 2026
• Study Start (Estimated): November 30, 2026
• Primary Completion (Estimated): September 3, 2032
• Study Completion (Estimated): September 3, 2032
• Last Updated: July 21, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share