grant

Passive cognitive assessment across the menopausal transition

Organization KEYWISE, INC.Location SAN DIEGO, UNITED STATESPosted 11 Sept 2025Deadline 31 Aug 2026
NIHUS FederalResearch GrantFY2025AD related dementiaADRDAI basedAI technologyAccelerationAccelerometerAccuracy of DiagnosisAchievementAchievement AttainmentAddressAffectAlzheimer risk factorAlzheimer's and related dementiasAlzheimer's dementia and related dementiaAlzheimer's dementia or related dementiaAlzheimer's disease and related dementiaAlzheimer's disease and related disordersAlzheimer's disease or a related dementiaAlzheimer's disease or a related disorderAlzheimer's disease or related dementiaAlzheimer's disease related dementiaAlzheimer's disease riskAmmon HornAndroidAssessment instrumentAssessment toolCaringCell PhoneCellular PhoneCellular TelephoneClinicalClinical TrialsCognitionCognitiveCognitive DisturbanceCognitive ImpairmentCognitive ManifestationsCognitive SymptomsCognitive declineCognitive function abnormalCornu AmmonisDataDevelopmentDigital biomarkerDisease ProgressionDisturbance in cognitionEarly identificationEnvironmentEthnic OriginEthnicityEventFemale HealthFocus GroupsFoundationsFundingGoalsHealth CareHippocampusHourImpaired cognitionIndividualMapsMarketingMeasuresMenopausal SymptomMenopauseMetadataMissionMobile PhonesNational Institute of AgingNational Institute on AgingNeurobehavioral ManifestationsNeurobehavioral Signs and SymptomsNeurocognitionNeuropsychologiesNeuropsychologyParticipantPatient RecruitmentsPerimenopausalPerimenopausePhasePositionPositioning AttributePost-MenopausePost-menopausal PeriodPostmenopausal PeriodPostmenopauseProcessPublishingQuestionnairesRaceRacesResearchRiskSTTRSecondary toSightSleep disturbancesSmall Business Technology Transfer ResearchSpeedStandardizationSymptomsTechnologyTestingTimeUnited StatesValidationVisionWhite Matter HyperintensityWomanWomen's Healthaberrant sleepaccelerometryactivity monitoractivity trackerafter menopausealzheimer riskartificial intelligence basedartificial intelligence technologyassociated symptombrain fogclinical relevanceclinically relevantco-morbid symptomco-occuring symptomcognitive abilitycognitive assessmentcognitive changecognitive dysfunctioncognitive functioncognitive losscognitive testingcommercializationcomorbid symptomconcurrent symptomcooccuring symptomcostdesigndesigningdevelop therapydevelopmentaldiagnostic accuracydigital markerdisrupted sleepdisturbed sleepdrug discoveryeconomic impactexecutive controlexecutive functionexperiencefeasibility testingfollowing menopausehippocampaliPhoneimpaired sleepimprovedinnovative technologiesintervention developmentirregular sleepiterative designkinematic modelkinematicsm-HealthmHealthmenopause transitionmeta datamobile healthneural imagingneuro-imagingneurobehavioral symptomneuroimagingneurological imagingneuropsychologicnovelparticipant recruitmentpast menopauseperi-menopausalperi-menopausephysical symptompost-menopausalpostmenopausalpostmenopausal statusprocessing speedracialracial backgroundracial diversityracial originracially diverseresponseresponse to therapyresponse to treatmentsleep disruptionsleep dysregulationsleep/wake disruptionsleep/wake disturbancesmart phonesmartphonesocio-economicsocio-economicallysocioeconomicallysocioeconomicssymptom associationsymptom comorbiditytech developmenttechnology developmenttemporal measurementtemporal resolutiontherapeutic responsetherapy developmenttherapy responsetime measurementtooltransition to menopausetransitional menopausetreatment developmenttreatment responsetreatment responsivenessusabilityvalidationsvasomotor symptomsvisual function
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Full Description

PROJECT SUMMARY
Menopause is a traditionally underappreciated and undertreated condition that affects approximately 1 billion

women worldwide. Half of those women also have significant symptoms associated with the menopausal

transition, including sleep disturbances, vasomotor symptoms, and brain fog or cognitive dysfunction. One of

the reasons for the treatment gap in menopause care relates to difficulties in obtaining reliable measures of

cognitive dysfunction with high temporal resolution. The goal of the proposed project is to further develop and

test a novel, passive, unobtrusive tool for assessing cognitive function through smartphone interactions, called

Skye, for use in peri- and post-menopausal women. Phase I will support the cross-platform development of

Skye (Aim 1) and will test the feasibility and usability of Skye, utilizing an iterative design process with two

focus groups of peri- and post-menopausal women from diverse socioeconomic and racial/ethnic backgrounds

(Aim 2). In Phase II, we will leverage existing studies funded by the National Institute on Aging to validate the

cognitive score derived from Skye with gold-standard neuropsychological assessments and neuroimaging

measures. We will further test the hypothesis that Skye is sensitive enough to detect cognitive changes

secondary to sleep disturbances and vasomotor symptoms in peri- and post-menopausal women (Aim 3). The

successful achievement of the Aims will provide vital evidence for the utility of Skye in addressing the unmet

needs of a growing market estimated to cost the United States $26.6 billion annually.

Grant Number: 1R42AG094389-01
NIH Institute/Center: NIH

Principal Investigator: Olusola Ajilore

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