Study complements ongoing trial in the prodromal to mild population
The trial, posted here, is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the clinical efficacy, safety, pharmacokinetics, and pharmacodynamics of MTAU9937A, RO7105705 in an estimated 260 patients with moderate AD dementia. The study consists of a screening period, a double-blind treatment period, an optional open-label extension (OLE) period, and a safety follow-up period. The primary endpoints are change from baseline to Week 49 in cognitive function as measured by the Alzheimer's Disease Assessment Scale, Cognitive Subscale, 11-item version (ADAS-Cog11) and change from baseline to Week 49 in functional capacities as measured by the Alzheimer's Disease Cooperative Study-Daily Living Inventory (ADCS-ADL).
This anti-Tau monoclonal antibody is part of the strategic collaboration with Genentech entered into in 2012 for the research, development and commercialization of monoclonal humanized antibodies against Tau protein. RO7105705 is a humanized anti-Tau monoclonal antibody with a high specificity for pathological Tau, designed to intercept the cell-to-cell spread of pathological Tau in the extracellular space of the brain.
Tau pathology spreads with a characteristic spatiotemporal pattern throughout the brain, coinciding with both clinical symptoms and disease progression in AD. Slowing the propagation of tau pathology may therefore slow disease progression and reduce cognitive decline, and anti-tau therapies have shown promise in slowing the progression of tau pathology in animal models of tauopathy.
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