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

NCT ID
NCT07717411
Registry status
Recruiting
Study type
Interventional
Phase
Phase 3
Sponsor
Hoffmann-La Roche
Conditions
Alzheimer's Disease

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Efficacy and Safety Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease

Enrollment: 1600 participants (Estimated).

What is being studied

  • Drug: Placebo
  • Drug: Trontinemab

Who may be eligible

Ages
55 Years to 80 Years
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility criteria.

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 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 Exclusion Criteria: * 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 * Abnormally low serum levels of folic acid or vitamin B12 deficiency that are judged to be clinically significant and/or may impact cognition as per the investigator's judgment * Current HIV, hepatitis B, or hepatitis C infection that has not been adequately treated in the opinion of the investigator * History of malignancy * Any previous administration of active immunotherapy (vaccine) that is being evaluated to prevent or postpone cognitive decline * Any previous or current use of passive immunotherapy (immunoglobulin) or other long-acting biologic agent that is approved or under evaluation or has been evaluated to prevent or postpone cognitive decline * Any other investigational treatment within 5 half-lives or 4 months prior to screening, whichever is longer * Intravenous (IV) or subcutaneous immunoglobulin therapy within 5 half-lives or 4 months prior to baseline whichever is longer * Anticoagulation medications at screening and there should be no plans to initiate any prior to or after randomization * Any treatment with cholinesterase inhibitors * Antipsychotic or neuroleptic medications within 3 months of screening, except as brief treatment for a non-psychiatric indication * Individuals with chronic use of opiates or opioids, benzodiazepines, barbiturates, or hypnotics, antidepressants or medication to treat anxiety should be on a stable dose for at least 8 weeks before baseline * Currently enrolled in an interventional study including those requiring investigational medicinal product (IMP) or involving any type of medical research that may interfere with study cognitive assessments * Residence in a skilled nursing facility such as a convalescent home or long-term care facility

Study locations

34 study locations are listed.

Recruiting site status is explicitly provided for 34 locations; 34 are listed as Recruiting.

Countries: Argentina, Australia, Canada, China, Taiwan, United Kingdom, United States

  • New South Wales, Australia: 2
  • British Columbia, Canada: 1
  • Ontario, Canada: 1
  • Guangdong, China: 1
  • Hebei, China: 1
  • Shaanxi, China: 1
  • California, United States: 4
  • Florida, United States: 6
  • New York, United States: 1
  • Virginia, United States: 1

Sample of listed locations

  • Hospital Italiano de Buenos Aires — Buenos Aires, C1181ACH, Argentina — Recruiting
  • Royal Prince Alfred Hospital — Camperdown, New South Wales, 2050, Australia — Recruiting
  • KaRa Institute of Neurological Diseases — Macquarie Park, New South Wales, 2113, Australia — Recruiting
  • Kelowna Health and Memory Centre Ltd. — Kelowna, British Columbia, V1Y 5A8, Canada — Recruiting
  • Toronto Memory Program — Toronto, Ontario, M3B 2S7, Canada — Recruiting
  • The second Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, 510260, China — Recruiting
  • The First Hospital of Hebei Medical University — Shijiazhuang, Hebei, 050031, China — Recruiting
  • Yan'an University Xianyang Hospital — Xianyang, Shaanxi, 712000, China — Recruiting
  • Beijing Friendship Hospital Affiliated of Capital University of Medical Science — Beijing, 100050, China — Recruiting
  • Xuanwu Hospital, Capital Medical University — Beijing, 100053, China — Recruiting
  • Sir Run Run Shaw Hospital Zhejiang University — Hangzhou, 310016, China — Recruiting
  • Nanjing First Hospital — Nanjing, 210029, China — Recruiting
  • The Second Affiliated Hospital of Nanjing Medical University — Nanjing, 210003, China — Recruiting
  • The Second Affiliated Hospital of Suzhou University — Suzhou, 215025, China — Recruiting
  • Taipei Veterans General Hospital — Taipei, 11217, Taiwan — Recruiting
  • Scottish Brain Sciences — Aberdeen, AB25 2XE, United Kingdom — Recruiting
  • Re:Cognition Health Birmingham — Birmingham, B16 8QQ, United Kingdom — Recruiting
  • Surrey and Borders NHS Foundation Trust — Chertsey, KT16 9AU, United Kingdom — Recruiting
  • Scottish Brain Sciences — Edinburgh, EH12 5PJ, United Kingdom — Recruiting
  • Charing Cross Hospital — London, W6 8RF, United Kingdom — Recruiting
  • Re:Cognition Health London — London, W1G 8TB, United Kingdom — Recruiting
  • Moorgreen Hospital — Southampton, SO30 3JB, United Kingdom — Recruiting
  • Irvine Center for Clinical Research — Irvine, California, 92614, United States — Recruiting
  • Healthy Brain Clinic — Long Beach, California, 90804, United States — Recruiting
  • Oakland Clinical — Oakland, California, 94609, United States — Recruiting

Study details

Start date
November 30, 2026
Primary completion date
September 3, 2032
Completion date
September 3, 2032
First posted
July 21, 2026

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT07717411
Registry last updated
October 13, 2026
QualifiedStudies registry data refreshed
October 19, 2026
QualifiedStudies record fetched
October 19, 2026

View NCT07717411 on ClinicalTrials.gov

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