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ACE-D: Accelerating Cognition-guided signatures to Enhance translation in Depression

Award Number: UF1MH136062
ORGANIZATION: NATIONAL INSTITUTE OF MENTAL HEALTH
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 05/03/2024
PERIOD OF PERFORMANCE END DATE: 02/28/2029

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ACE-D: Accelerating Cognition-guided signatures to Enhance translation in Depression - Project Summary/Abstract The lack of accessible, individual-level measurements suited to inform clinical decision-making is a critically unmet need in depression, the leading cause of disability globally. Persistent cognitive impairments from depression are a major contributor to disability. Our objective is to optimize, validate, and deploy a clinical cognitive signature using behavioral measures that have a basis in neural mechanisms, enabling individualized assessment at scale suited to personalized clinical prognostic and treatment selection decisions. We will extend our pioneering work in identifying a cognitive phenotype of depression derived from computerized behavioral ‘WebNeuro’ tasks that align with the RDoC cognitive control construct, to be complemented by a novel, research-based smartphone ‘BiAffect’ application for finer-grained, passively sampled behavioral metrics. In Aim 1, we will optimize a clinical cognitive signature for individual-level predictions based on our already identified cognitive phenotype. We leverage our unique, large existing multi-modal datasets with common cognitive data elements totaling 3,082 participants. These datasets span participants with major depressive disorder assessed pre-post treatment with pharmacotherapy and behavioral therapy, pre-post naturalistic trajectories, and matched healthy participants from the same sites. We will systematically optimize a clinical cognitive signature by generating trial-by-trial individualized scores on cognitive control tasks, with refined norms, and evaluate these scores in predictive models. We will also refine the mechanistic understanding of the clinical cognitive signature in the subset of participants who also have neuroimaging data. In Aim 2, we will evaluate the clinical cognitive signature in combination with digital phenotyping at scale in a new prospective sample of 1,200 adults with depression, to be recruited remotely. To enhance generalizability, the sample will span a broad range of symptom severity and functional impairment. We will complement WebNeuro with the BiAffect technology, both suited for remote administration, to quantify finer-grained individual variations in behavior throughout the day. This new cohort will complete repeat assessments for symptom and disability outcome predictions over 8 weeks with a 6-month follow-up. In Aim 3, we will validate the clinical cognitive signature for prospective stratification in a randomized clinical trial with 160 participants from the Stanford Bay Area and Chicago sites. We will prospectively identify participants with a prominent clinical cognitive signature (designated as C+) and those with a relative absence of the signature (designated as C-). Participants will be randomly assigned to receive sertraline plus guanfacine or sertraline plus placebo. Guanfacine is chosen because it has been shown to ameliorate cognitive deficits in depression based on the published preliminary findings from our team. The expected end product will be a clinically validated cognitive signature using a behavioral assessment tool that can be readily scaled and translated into routine clinical practice to inform prognostic and tailored treatment decisions. The project will generate a unique FAIR-compliant dataset enabling future scaling using machine learning and AI.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $11,303,806 )
2026	2026	THE LELAND STANFORD JUNIOR UNIVERSITY	450 JANE STANFORD WAY	STANFORD	CA	94305	SANTA CLARA	USA	Mental Health Research Grants	000	3	4/8/2026	EXTENSION WITH OR WITHOUT FUNDS	$11,303,806
														Subtotal = $11,303,806

Grand Total All Awards = $11,303,806

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ACE-D: Accelerating Cognition-guided signatures to Enhance translation in Depression

Award Number: UF1MH136062

ORGANIZATION: NATIONAL INSTITUTE OF MENTAL HEALTH

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 05/03/2024

PERIOD OF PERFORMANCE END DATE: 02/28/2029

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