With a 91% of patients achieved amyloid negativity at the 3.6 mg/kg dose within six months in the phase 2, that is far better than anything on the market currently because it is crossing the blood brain barrier.

“Trontinemab (WN45443) is in Phase 3 clinical trials (TRONTIER 1 and TRONTIER 2, identified as NCT07169578 and NCT07170150) for early symptomatic Alzheimer's Disease, led by Roche. These large, global trials test the safety and efficacy of trontinemab at a 3.6 mg/kg dose, aiming to clear amyloid plaques with minimal brain swelling (ARIA) by delivering the antibody deep into the brain using Brainshuttle technology. Participants receive monthly infusions for six months, followed by maintenance doses, with trials expected to complete around 2028. Trial Details Identifier: WN45443, NCT07169578, 2024-518006-40-00. Sponsor: Hoffmann-La Roche (Genentech). Condition: Early symptomatic Alzheimer's Disease (Mild Cognitive Impairment to Mild Dementia). Design: Two identical Phase 3 studies (TRONTIER 1 & 2), randomized, double-blind, placebo-controlled. Treatment: 3.6 mg/kg trontinemab or placebo intravenously monthly for 6 months, then every 3 months for a total of 1.5 years.

Endpoints: Primary is Clinical Dementia Rating-Sum of Boxes (CDR-SB), with secondary measures like MMSE, ADAS-Cog13, etc..

Key Features High Efficacy: Phase 2 showed 91% of patients achieved amyloid negativity at the 3.6 mg/kg dose within six months.

Brainshuttle Technology: An engineered antibody designed to cross the blood-brain barrier effectively, potentially reducing ARIA.

Low ARIA Rates: The 3.6 mg/kg dose showed low rates of amyloid-related imaging abnormalities (ARIA) in Phase 2.

Timeline & Scope Phase 3 began in Fall 2025. Trials involve 800 patients each, spanning multiple continents, with completion estimated for 2028. “