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] (NCT07170150)

The purpose of this study is to compare the effects, good or bad, of trontinemab versus placebo on participants with AD. In this study, participants will get either trontinemab or placebo. Participants aged 50 - 90 years (inclusive) with early symptomatic AD will be eligible for inclusion. The effects of trontinemab versus placebo on clinical progression of AD will be evaluated through cognitive assessment and imaging.

Trial phase

Phase 3

Trial participation type

This trial has been designed for the Clinical Research of a Drug.

Principal investigator

A/Prof David Darby

Key inclusion data

Inclusion Criteria: Ability to provide written consent with an Informed Consent Form signed by the participant (co-signed by the participant’s legally authorized representative, if required by the local regulations, guidelines, and independent Ethics Committee [EC] or Institutional Review Board [IRB]) Age ≥50 years and ≤ 90 years at the time of signing Informed Consent Form| Body weight of 150 kg or less Fluency in the language of the tests used at the study site Exclusion Criteria: History or presence of clinically significant cerebrovascular disease (e.g., intracranial or cerebral vascular malformations, aneurysm, intracranial macrohemorrhage). In case of a small, isolated developmental venous anomaly PI’s judgement applies. History of severe, clinically significant (persistent neurologic deficit or structural brain damage) CNS trauma History or presence of clinically significant intracranial mass (e.g., glioma, meningioma). For meningiomas or arachnoid cysts  10 mm, PI’s judgement applies. History of schizophrenia, schizoaffective disorder, major depression, or bipolar disorder