[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"apoe-4-positive\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:apoe-4-positive":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100632625","predicting-pre-dementia-100632625",false,"NCT07516119","Predicting Pre-dementia","Assessing Tools That Predict and Stage Mild Cognitive Impairment","Inclusion Criteria:\n\nAge\n\nAge 55 years or older at enrollment.\n\nAPOE Genotype\n\nDocumented carrier of at least one APOE ε4 allele, based on prior testing (e.g., clinical APOE testing, prior genetic panel, research cohort genotyping, or direct-to-consumer testing).\n\nExisting Genomic Data for PRS\n\nWhole-genome sequencing (WGS) data already completed, with willingness to provide existing WGS data files (e.g., VCF, FASTQ, or equivalent) to the study team for Alzheimer's disease polygenic risk score (PRS) calculation; or\n\nIf WGS is not available, prior high-density or targeted genotyping array data covering Alzheimer's disease risk loci, with willingness to provide these data for PRS calculation (feasibility of array-based PRS will be evaluated case-by-case).\n\nNote: The study does not perform APOE genotyping or WGS as part of the research; these must be completed before enrollment.\n\nCognitive Status at Baseline\n\nCognitively normal or very mildly impaired at baseline, defined by:\n\nDigital cognitive assessment and\u002For Punto Test consistent with a Global Clinical Dementia Rating (CDR) of 0 or 0.5.\n\nNo clinical diagnosis of dementia.\n\nFor cognitively normal (CN) and subjective cognitive decline (SCD) participants, staging by the Progression and Risk (P\\&R) model (combining PRS, biomarker, and cognitive data) will be applied for risk stratification.\n\nAbsence of Baseline AD-MCI by Biomarkers\n\nDoes not currently qualify for Alzheimer's disease-related MCI (AD-MCI), operationalized as no evidence of MCI with plasma or CSF pTau217 level above a validated cutoff for AD-MCI pathology.\n\nCapacity and Participation Ability\n\nAble to provide informed consent (with capacity assessments and, where applicable, involvement of a legally authorized representative per institutional policy and IRB approval).\n\nAble and willing to comply with study procedures, including clinic visits, cognitive testing, and biospecimen collection.\n\nWillingness to Use Digital Monitoring Tools\n\nWilling to wear and\u002For carry digital devices for continuous or frequent monitoring (e.g., smartphone app, wearable sensors such as Oura Ring, sleep device), and to participate in app-based cognitive and speech assessments.\n\nData-Sharing Authorizations\n\nWillingness to sign data release authorizations allowing the study to obtain existing genomic data (WGS or array) and relevant electronic medical record (EMR) data needed for risk modeling and outcome adjudication.\n\nExclusion Criteria:\n\nBaseline Dementia Diagnosis\n\nClinical diagnosis of dementia of any cause at baseline.\n\nMajor Neurological Disorders Affecting Cognition\n\nHistory of major neurological conditions that in the investigator's judgment may confound cognitive assessment or outcomes, such as:\n\nParkinson's disease.\n\nStroke with residual neurological deficits.\n\nEpilepsy with frequent seizures.\n\nMajor Psychiatric Illness\n\nMajor psychiatric disorders that significantly interfere with participation or data interpretability, such as uncontrolled major depressive disorder or schizophrenia, as judged by the investigator.\n\nSerious or Unstable Medical Conditions\n\nUncontrolled systemic medical illness expected to limit life expectancy to less than approximately 3 years, including but not limited to unstable cardiac, hepatic, or renal disease.\n\nRecent Investigational or Disease-Modifying AD Treatments\n\nUse of investigational drugs or disease-modifying Alzheimer's therapies within 6 months prior to baseline, if such treatments are likely to confound biomarker trajectories or cognitive outcomes.\n\nInability or Unwillingness to Use Required Digital Tools\n\nLack of Required Genomic Documentation or Refusal to Share Data\n\nNo prior APOE genotype documenting at least one ε4 allele; or\n\nNo available WGS or suitable genotyping array data; or\n\nRefusal to share existing APOE\u002Fgenomic data and necessary EMR data with the study team.\n\nBaseline MCI with Positive pTau217\n\nVulnerable Populations Not Targeted\n\nChildren, prisoners, and pregnant individuals are not specifically targeted and will be excluded from enrollment.",true,"ALL","55 Years",{"count":20,"type":21},100,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to learn how well a multimodal \"Progression and Risk\" (PR) model can predict and stage early mild cognitive impairment (MCI) due to Alzheimer's disease in cognitively normal or very mildly impaired ApoE4-positive adults aged 55 and older. The main questions it aims to answer are:\n\nCan a prespecified proteogenomic PR model accurately predict conversion from cognitively normal (CN) or very mildly impaired status to pTau217-positive MCI Stage I within 24 months in ApoE4-positive adults?\n\nDoes adding digital monitoring features (e.g., sleep, activity, speech), EMR-lifestyle risk scores, and plasma biomarkers to a polygenic risk score (PRS) meaningfully improve risk stratification and time-to-conversion prediction compared with simpler models (e.g., PRS alone or standard clinical risk factors)?\n\nIf there is a comparison group: Researchers will compare performance of the full multimodal PR model (integrating PRS, plasma proteomics and other omics, digital monitoring, and EMR-lifestyle data) with simpler or reduced models (for example, PRS-only, biomarker-only, or models without continuous digital monitoring) to see if the full model provides higher discrimination (AUC\u002FROC), better calibration, and improved time-to-conversion prediction for CN to pTau217-positive MCI transitions.\n\nParticipants will:\n\nProvide prior genomic data (ApoE genotype and whole-genome sequencing or high-density genotyping array data) for calculation of an ancestry- and sex-normalized Alzheimer's disease PRS and assignment to PRS-based risk strata.\n\nAttend an in-person baseline visit and follow-up visits at months 6, 12, 18, and 24 (±2 months) for clinical evaluation, neurocognitive testing (including CDR and digital cognitive batteries), and venous or capillary blood collection for plasma pTau217 and other AD biomarkers, proteomic and methylome panels, and routine safety labs when indicated.\n\nUse digital devices (e.g., Oura Ring and smartphone-based tools) for continuous or frequent remote monitoring of sleep, activity, heart rate metrics, mobility\u002Flocation, and speech-linked digital cognitive tasks, with adherence checks at study visits.\n\nUndergo optional or sub-cohort procedures as clinically indicated or as resources allow, such as EEG, retinal hyperspectral imaging, MRI, or amyloid PET, and optionally allow clinically indicated lumbar puncture CSF samples and external clinical data to be shared with the study for exploratory biomarker analyses.",[25,26,27,28],"Mild Cognitive Impairment (MCI)","Alzheimer Dementia (AD)","Alzheimer Disease (AD)","APOE-4 Positive",[30,31,32,33,34],"Observational cohort preclinical Alzheimer's disease","ApoE4-positive cognitively normal adults 55+","Plasma pTau217 and blood biomarkers for MCI","Polygenic risk score and proteogenomic risk model","Digital cognitive assessment and Oura Ring monitoring","RECRUITING","2026-03-31",{"date":38,"type":39},"2026-04-07","ACTUAL",{"date":41,"type":21},"2026-04-15",{"date":43,"type":21},"2029-04-15",{"name":45,"class":46},"Prevention Research Consortium Corp.","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":16,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":58,"conditions":59,"keywords":74,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":47},"100303705","retinal-imaging-in-neurodegenerative-disease-100303705","NCT03233646","Retinal Imaging in Neurodegenerative Disease","Evaluating the Retinal and Choroidal Microvasculature and Structure Using Multimodal Retinal and Choroidal Imaging in Neurodegenerative Disease: iMIND Research Study","Inclusion Criteria:\n\n* Adults with neurodegenerative disease ((MCI, PD, AD, FTD, DLB, ALS, MS, HD, TBI, concussion, PTSD and other neurodegenerations as well as Down Syndrome)\n* Adults without neurodegenerative disease\n\nExclusion Criteria:\n\n* Inability to cooperate with or complete testing or other neurologic or age- related ocular conditions that would impact image acquisition.\n* Eyes that have had intraocular surgery, other than cataract surgery.\n\nIf two eyes satisfy the inclusion criteria, both eyes will be included in the study. If one eye satisfies the inclusion criteria, the eye that qualifies will be included in the study.","18 Years",{"count":57,"type":21},2000,"This study aims to develop and evaluate biomarkers using non-invasive optical coherence tomography (OCT) and OCT angiography (OCTA) as well as ultra-widefield (UWF) fundus photography to assess the structure and function of the retinal and choroidal microvasculature and structure in persons with mild cognitive impairment (MCI) and Alzheimer's Disease (AD), Parkinson's Disease (PD), or other neurodegenerative disease, diseases as outlined.",[60,61,62,63,64,65,66,67,28,68,69,70,71,72,73],"Alzheimer's Disease","Mild Cognitive Impairment","Parkinson's Disease","Multiple Sclerosis","Huntington Disease","Lewy Body Dementia","Frontotemporal Dementia","Amyotrophic Lateral Sclerosis (ALS)","Traumatic Brain Injury","Concussion","Post-Traumatic Stress Disorder","Down Syndrome","Neuro-Degenerative Disease","Normal Cognition",[75,76,77,78,79,80,81,82,83,84,85],"OCT angiography (OCTA)","Optical Coherence Tomography (OCT)","Vessel Density","Superficial Capillary Plexus","Retinal microvasculature","Scanning Laser Ophthalmoscopy","Ultra-widefield (UWF) Imaging","Perfusion Density","Retinal Nerve Fiber Layer","Ganglion Cell Inner Plexiform Layer","Choroidal Vascularity Index","2026-02-02",{"date":88,"type":39},"2026-02-04",{"date":90,"type":39},"2017-07-20",{"date":92,"type":21},"2026-12-31",{"name":94,"class":46},"Duke University"]