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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age55-80
SponsorHoffmann-La Roche

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Trontinemab
  • Placebo

Treatment groups

1,600 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators