ALTO-100 Trial: Using Cognitive Biomarkers to Personalize Depression Treatment

Alto Neuroscience has completed enrollment for its Phase 2b trial of ALTO-100, aimed at treating major depressive disorder. This study evaluates the drug's efficacy using a cognitive biomarker to personalize treatment. Such an approach could revolutionize psychiatric care by tailoring treatments to individual neurobiological profiles, potentially increasing efficacy and reducing the trial-and-error commonly associated with depression therapies.

The ALTO-100 trial, involving 300 adult participants at 34 sites across the United States, aims to provide new insights into personalized depression treatment. ALTO-100, a promising oral small molecule, has shown potential in promoting neurogenesis and neuroplasticity—key factors in brain health and recovery from depressive states. 

In a Phase 2a trial, the drug demonstrated favorable safety and efficacy, especially in patients identified through a novel cognitive biomarker—a verbal memory test linked to hippocampal function.

Dr. Amit Etkin, founder and CEO of Alto Neuroscience, expressed optimism about the study's progress, stating, “The completion of enrollment in this study marks an important achievement. We look forward to reporting topline results later this year, which, if positive, will propel us into Phase 3 and ultimately bring us one step closer to realizing the potential of precision psychiatry.”

The ongoing Phase 2b study is a double-blind, placebo-controlled evaluation designed to confirm ALTO-100's efficacy using the Montgomery-Åsberg Depression Rating Scale (MADRS). This standard measurement assesses changes in depression severity over a six-week treatment period. Importantly, the study enriches for patients exhibiting a specific memory deficit, offering a targeted approach to treatment based on Alto's Precision Psychiatry Platform™.

“Major depressive disorder is among the most prevalent CNS conditions and is a leading cause of disability worldwide,” said Dr. Adam Savitz, M.D., Ph.D., chief medical officer of Alto. “We are pleased with the receptivity to our neurocognitive test. The execution of this study demonstrates the potential for this test to be implemented broadly in clinical practice.”

Alto Neuroscience which has a robust pipeline of novel drug candidates for various mental health conditions, continues to lead advancements in the application of neuroscience to psychiatry, aiming to significantly improve patient outcomes in mental health care.

About Author: Tracy Mokwe

With over 3 years of experience as a medical laboratory scientist and writer, I am passionate about translating complex scientific information into clear and accessible content. My expertise lies in medical sciences, laboratory science and research, digital health, AI, and cybersecurity in healthcare.