Whitney Health · Developed by Kainoa Labs
For Research Partners
A clinical research platform for cognitive and neurobehavioral endpoints
Whitney Health is the only validly and unlimitedly repeatable, fully configurable digital neurobehavioral assessment platform with FDA Breakthrough Device designation for the differential diagnosis of MCI. For research partners, it provides what no other cognitive assessment tool currently offers: clinically-validated sensitivity and specificity to detect subtle treatment effects, the flexibility to adapt to any trial design, and the measurement infrastructure to deliver both performance-based assessment and patient-reported outcomes in a single system — without limits on how often it can be administered.
Trial protocol
Any time point structure, population, and battery composition.
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Whitney configuration
Performance tasks and questionnaires in one repeatable system.
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Endpoint data
Scored outputs, longitudinal performance, and cohort comparisons.
The Cognitive Performance Measurement Problem in Clinical Trials
The most common reason a drug trial fails to demonstrate cognitive benefit is not that the drug doesn't work. It's that the instruments used to measure cognition weren’t designed for this purpose.
Existing cognitive screens have well-documented ceiling effects. They are vulnerable to practice effects that make repeated administration unreliable. And, they lack the resolution to distinguish between cognitive subdomains that may respond differently to treatment. For drug trials where the cognitive effect may be subtle, early-stage, or distributed across domains, these instruments are inadequate.
Whitney Health was built to address exactly this problem and has validated against it.
0.94 – 0.97
AUROCs for the primary MCI subtypes against gold-standard neuropsychological reference batteries.
Rapid change
Sensitivity to rapid, subtle cognitive change validated in ketamine therapy monitoring.
Any frequency
Practice-effect-free architecture enabling reliable measurement at any frequency.
Patented
The only fully configurable neurobehavioral assessment platform with unlimited repeatability.
Three Advantages No Other Platform Offers
Unlimited Repeatability
Patented methods generate equivalent, parallel tasks across unlimited administrations.
Longitudinal results reflect true cognitive change, not test familiarity.
Add unplanned time points, respond to protocol amendments without instrument constraints.
Full Protocol Configurability
Deliver both performance-based cognitive assessments and questionnaires through a single platform.
Configure time points, battery composition, and participant workflows to match your protocol exactly.
Your Clinical Trial Battery and Protocol is defined by your trial design.
Measurement Sensitivity
AUROCs of 0.94 – 0.97 for aMCI and naMCI vs. healthy controls.
AUROC 0.85 for pre-clinical, a-symptomatic MCI in cross-study generalization.
Validated sensitivity to rapid treatment-related cognitive change.
Multi-domain coverage.
The Research Platform
A single configurable system for performance-based cognitive assessment, patient-reported outcomes, longitudinal scheduling, and trial-ready data delivery.
Unsupervised Remote Administration
Research participants may complete Whitney Health assessments remotely, with or without supervision.
This supports large-scale, geographically distributed, longitudinal and Phase-IV trials.
Configurable Battery per Time Point
Researchers configure the assessment battery by time point.
Scheduling, participant notification, and session assignment are automated.
Integrated Questionnaire Delivery
Patient-reported outcomes, self-report measures, caregiver reports, health history questionnaires, and validated clinical instruments can be delivered through the same platform as performance-based cognitive assessment.
Unlimited Repeatability (Patented)
The platform’s patented methods generate a unique, equivalent version of each task per administration. There is no upper limit on repeatable assessment (patented).
Scored performance results
Scored variables and index scores, normative comparisons, longitudinal performance patterns, and cohort comparisons are delivered through the Whitney Health platform.
Flexible Service Model
The platform can be deployed as a standalone assessment instrument or as a full-service offering including technician supervision and neuropsychologist review.
An important distinction for dual-status participants.
Research participants who are also receiving clinical care, (whose assessment data will be used to inform clinical care), require the supervised clinical protocol, including technician supervision and neuropsychologist review. Pure research participants with no clinical care relationship may complete unsupervised sessions. This distinction is configured by protocol during platform setup.
Therapeutic Areas
Whitney Health’s sensitivity and specificity make it applicable across trials that measure the effects of a drug (beneficial or adverse) on neurobehavioral function.
Anti-Amyloid Therapies
The approval of lecanemab and donanemab has created an urgent need for cognitive endpoint measurement that current tools cannot provide: the differentiation of aMCI, naMCI, and late life depression at baseline to ensure precise patient selection, and a longitudinal measurement sensitive enough to detect treatment effect.
Whitney Health addresses both. Its differential diagnostic accuracy across aMCI, naMCI, and late-life depression enables precise baseline characterization and checks on cohort assignment. Its unlimited repeatable, practice-effect-free longitudinal architecture provides the endpoint measurement resolution that anti-amyloid trials require. For trials evaluating disease-modifying therapies in MCI populations, Whitney Health is the most sensitive validated digital cognitive endpoint instrument currently available.
GLP-1 Receptor Agonists
Emerging evidence suggests GLP-1 receptor agonists — including semaglutide and related compounds — may have neuroprotective effects with potential cognitive benefits, particularly relevant to populations with type 2 diabetes and pre-diabetes. The commercially and scientifically significant question is whether these agents confer cognitive protection before significant decline occurs.
These are populations where cognitive changes are subtle, early-stage, and distributed across domains. Whitney Health's sensitivity profile brings real cognitive performance measurement benefits in exactly this population.
Oncology: Chemotherapy-Related Cognitive Impairment
Chemotherapy-related cognitive impairment affects a substantial proportion of cancer patients and is increasingly a regulatory and quality-of-life endpoint in oncology trials. The changes are often subtle, multi-domain, and evolve rapidly across a treatment course — precisely the profile that standard cognitive screens are ill-suited to measure.
Whitney Health's multi-domain assessment, sensitivity to processing speed and attention deficits, and unlimited repeatable longitudinal tracking make it well-suited for detecting chemotherapy-related cognitive change and monitoring cognitive recovery following treatment. The platform's ability to deliver both performance-based assessment and patient-reported outcomes in a single system reduces participant burden and simplifies data management across a complex treatment timeline.
Anesthetics & Perioperative Cognitive Decline
Postoperative cognitive dysfunction (POCD) — cognitive decline following surgery and anesthesia, particularly in older adults — is an increasingly scrutinized phenomenon in anesthetic development and surgical protocol research. Measuring it requires sensitivity to subtle pre-to-post cognitive change in older adult populations, with the ability to assess repeatedly across a perioperative timeline.
Whitney Health's validated performance in older adults (ages 57–94), multi-domain coverage, and unlimited repeatable architecture make it a strong candidate for POCD endpoint measurement. The platform can be configured to administer brief targeted batteries at frequent perioperative time points without instrument constraints — a capability no fixed-battery assessment tool can offer.
Antidepressants, Ketamine & Mood Disorder Treatments
Cognitive effects of depression treatment are increasingly relevant endpoints in clinical trials. Whitney Health has directly validated sensitivity to treatment-related cognitive change in this population: a five-site trial demonstrated statistically meaningful signal separation between pre-treatment, inter-infusion, and post-treatment assessments in patients receiving ketamine therapy.
Ketamine's cognitive effects are notoriously difficult to measure with standard instruments. Whitney Health isolated executive function changes associated with the earliest phases of depression recovery — precisely the signal that matters for evaluating treatment response and informing dose and timing decisions. For trials evaluating ketamine and ketamine analogues, psychedelics, antidepressants, or other mood disorder treatments where cognitive effects are a primary or secondary endpoint, this validated sensitivity is a direct proof of concept for the platform's applicability.
Working With Whitney Health
Strategic research partnership
Companion Diagnostic Co-Development
For therapeutic programs targeting conditions with measurable cognitive effects, Whitney Health is structured for CDx co-development. Integration into your trial protocol at defined time points generates the comparative effectiveness and longitudinal sensitivity data required for regulatory submission — while simultaneously strengthening your drug’s functional outcomes narrative for prescribers and payers.
Platform Integration
Whitney Health easily integrates into your trial infrastructure as the cognitive and neurobehavioral assessment instrument and platform. We work with clinical operations and data management teams to configure participant onboarding, battery selection by time point, questionnaire integration, data output format, and longitudinal scheduling.
Per-Participant Pricing
Research deployments are priced on a per-participant basis. Pricing varies by protocol complexity, battery composition, service level, and study volume. Contact our research team for a protocol-specific quote.
Regulatory Support
We provide FDA Breakthrough Device designation materials, published validation data, and platform technical specifications to support IND applications, protocol submissions, and IRB filings that reference Whitney Health as a cognitive endpoint instrument.
Protocol Design Support
We work with sponsors and CROs to identify the assessment battery and time point structure most likely to detect the cognitive effects of interest, based on the platform’s validated sensitivity profile across cognitive domains and populations.
Validation Foundation
The following publications document the platform’s clinical development and performance across MCI, stroke, aphasia, late-life depression, and healthy aging.
Sloane KL, Fabian R, Wright A, Saxena S, Kim K, Stein CM, Keser Z, Glenn S, Hillis AE. Supervised, self-administered tablet-based cognitive assessment in neurodegenerative disorders and stroke. Dementia and Geriatric Cognitive Disorders. 2023.
Mefford JA, Zhao Z, Heilier L, Xu M, Zhou G, Mace R, Sloane KL, Sheppard SM, Glenn S. Varied performance of picture description task as a screening tool across MCI subtypes. PLOS Digital Health. 2023.
Sloane KL, Mefford JA, Zhao Z, Xu M, Zhou G, Fabian R, Wright AE, Glenn S. Validation of a mobile, sensor-based neurobehavioral assessment with digital signal processing and machine learning analytics. Cognitive and Behavioral Neurology. 2022.
Berube S, Nonnemacher J, Demsky C, Glenn S, Saxena S, Wright A, Tippett DC, Hillis AE. Stealing cookies in the twenty-first century: Measures of spoken narrative in healthy versus speakers with aphasia. American Journal of Speech-Language Pathology. 2019.
Whitney Health is a product of Kainoa Labs, Inc.