The overarching aim of Alto Neuroscience is to advance brain-based biomarkers for psychiatric disorders in order to both optimize treatment pathways and drive the development of novel pharmacological and non- pharmacological interventions. Alto does this by developing and applying sophisticated machine learning computational models to electroencephalography (EEG) data collected at scale in real-world clinical treatment contexts. Specifically, in this direct-to-phase II SBIR proposal we will refine, and then independently validate, two EEG-based candidate biomarkers we have identified for stratifying patients with depression in a manner that both factors biological heterogeneity and informs treatment response. One of our biomarkers was derived in a ?top-down? (i.e. supervised) manner by trying to directly predict treatment outcome, while the other biomarker presents a complimentary ?bottom-up? (i.e. unsupervised) approach that begins by first identifying the most biologically homogeneous subset of patients and then testing the treatment relevance of the subtyping. Together, these findings represent very robust individual patient-level treatment-relevant EEG biomarkers, and in both cases, help define a critically-important objective approach to prospectively identifying and treating treatment- resistant depressed patients. A successful outcome of the proposed work would yield the first FDA-cleared biomarkers for stratifying psychiatric conditions. It would also provide a basis for targeted development of pharmacological and non-pharmacological interventions based on the EEG biomarkers. Both outcomes hold substantial commercial value and exciting potential for transforming psychiatry.

Public Health Relevance

The overarching aim of Alto Neuroscience is to advance brain-based biomarkers for psychiatric disorders in order to both optimize treatment pathways and drive the development of novel pharmacological and non- pharmacological interventions. Here we propose to refine, and then independently validate, two EEG-based candidate biomarkers we have identified for stratifying patients with depression in a manner that both factors biological heterogeneity and informs treatment response. A successful outcome of the proposed work would yield the first FDA-cleared biomarkers for stratifying psychiatric conditions. It would also provide a basis for targeted development of pharmacological and non-pharmacological interventions based on the EEG biomarkers.

Agency
National Institute of Health (NIH)
Institute
National Institute of Mental Health (NIMH)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
5R44MH123373-02
Application #
10116492
Study Section
Special Emphasis Panel (ZRG1)
Program Officer
Grabb, Margaret C
Project Start
2020-03-01
Project End
2023-02-28
Budget Start
2021-03-01
Budget End
2022-02-28
Support Year
2
Fiscal Year
2021
Total Cost
Indirect Cost
Name
Alto Neuroscience, Inc.
Department
Type
DUNS #
117142263
City
Palo Alto
State
CA
Country
United States
Zip Code
94303