[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657638":3},{"organization":4,"outcomesModule":7,"designInfo":83,"detailedDescription":86,"studyPopulation":87,"armGroups":82,"interventions":82,"overallOfficials":82,"centralContacts":88,"locations":97,"responsibleParty":293,"collaborators":82,"id":297,"slug":298,"hasResults":299,"nctId":300,"briefTitle":301,"officialTitle":302,"acronym":303,"eligibilityCriteria":304,"healthyVolunteers":299,"sex":305,"minAge":306,"maxAge":82,"enrollmentInfo":307,"targetDuration":82,"studyType":310,"phases":82,"briefSummary":311,"conditions":312,"keywords":315,"overallStatus":100,"whyStopped":82,"lastUpdateSubmitDate":321,"lastUpdatePostDateStruct":322,"startDateStruct":325,"completionDateStruct":327,"leadSponsor":329,"locationsCount":330},{"fullName":5,"class":6},"Prima Mente","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":24,"otherOutcomes":82},[9,13,17,21],{"measure":10,"description":11,"timeFrame":12},"Memory Clinic Performance Metrics","Time from the date of referral to the participant's Memory Clinic to the date of their first clinical assessment appointment. Reported as the mean number of days from referral to assessment.","From referral into the Memory Service through first Memory Clinic assessment (up to 12 months)",{"measure":14,"description":15,"timeFrame":16},"Usability and Acceptability of Biomarker Enabled Approach-Clinician Feedback","Clinician feedback on the usability and acceptability of the biomarker-enabled approach is assessed using a structured questionnaire. Responses are recorded using categorical Likert-type scales (e.g., Very satisfied to Very dissatisfied), scored from 1 to 5, with higher scores indicating greater satisfaction or perceived effectiveness of the triage system. We will aggregate scores into a composite overall acceptability score.","Every 3 months throughout the study (up to 36 months)",{"measure":18,"description":19,"timeFrame":20},"Health-Related Quality of Life (EQ-5D-5L)","Health-related quality of life measured using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L). The instrument includes five domains (mobility, self-care, usual activities, pain\u002Fdiscomfort, and anxiety\u002Fdepression), each scored on a 5-level scale ranging from 1 (no problems) to 5 (extreme problems). Domain responses are combined into a single EQ-5D-5L index score, where higher scores indicate better health-related quality of life.","Baseline (Study Visit 1), 2 weeks after return of results (Study Visit 3), and 12 months (Study Visit 4)",{"measure":22,"description":23,"timeFrame":20},"Health-Related Quality of Life - Self Rated Overall Health (EQ VAS)","Self-reported health status measured using the visual analogue scale (VAS) of the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L). The VAS ranges from 0 to 100, where 0 represents the worst health imaginable and 100 represents the best health imaginable. Higher VAS scores indicate better self-reported health status.",[25,29,33,37,40,44,48,51,54,58,62,66,70,74,78],{"measure":26,"description":27,"timeFrame":28},"Plasma Alzheimer's Disease Biomarkers (PrecivityAD2)","Plasma Alzheimer's disease biomarkers measured using the PrecivityAD2 blood test (C2N Diagnostics), including the amyloid beta 42\u002F40 ratio (Aβ42\u002F40), percent phosphorylated tau-217 (%p-tau217). The Amyloid Probability Score (APS2) is a composite algorithm score derived from these biomarkers and ranges from 0 to 100, correlated with clinical diagnosis and cognitive performance. Higher APS2 values indicate a greater likelihood of brain amyloid pathology consistent with Alzheimer's disease. APS2 values from 0-47 are interpreted as negative for brain amyloid plaques, while higher scores indicate increased probability of amyloid positivity.","Baseline (Study Visit 1) and 12 months (Study Visit 4)",{"measure":30,"description":31,"timeFrame":32},"Epigenetic Biomarkers in Cell-Free DNA","Methylation biomarkers in cell-free DNA analyzed by our models for associations with dementia-related clinical variables, including diagnosis and cognitive performance.","Baseline (Study Visit 1), 6 months (Study Visit 4), and 12 months (Study Visit 5)",{"measure":34,"description":35,"timeFrame":36},"Digital Cognitive Testing Performance (CANTAB)","Cognitive performance measured by CANTAB (Cambridge Neuropsychological Test Automated Battery) across multiple domains including episodic memory, visuospatial working memory, attention, associative learning, decision-making, visual-constructional ability, planning, processing speed, and task switching. Performance is reported as standardized z-scores and percentiles relative to an age-matched reference population. Z-scores range from negative to positive values, where 0 represents average performance; positive values indicate above-average cognitive performance and negative values indicate below-average performance.","Baseline (Study Visit 1), and 12 months (Study Visit 4)",{"measure":38,"description":39,"timeFrame":36},"Voice-Based Biomarkers from Free Speech Analysis","Speech parameters analysed from digitally recorded free speech tasks (narration of a complex scene with delayed repetition). Participants verbally describe the \"cookie jar\" scene and, after completing the CANTAB digital cognitive assessment, are asked to repeat the narration from memory. Speech recordings are analysed to derive quantitative speech parameters reflecting language production, including measures of fluency, lexical complexity, and acoustic features.These parameters are combined into a composite score reflecting evidence of dementia-related changes in speed, which is evaluated for associations with cognitive impairment.",{"measure":41,"description":42,"timeFrame":43},"Clinical and Demographic Data","Diagnosis, in-clinic cognitive test results, and demographic variables to characterise the study population and explore associations with dementia biomarkers.","Study Visit 2, occurring at variable timepoints up to 12 months after baseline depending on clinic wait times",{"measure":45,"description":46,"timeFrame":47},"Acceptability and Feedback of Biomarker Enabled-Approach","Participant acceptability of the genetic risk disclosure and biomarker enabled approach assessed using a study-specific 8-item questionnaire. The questionnaire includes categorical response options such as Likert-type ratings (e.g., strongly disagree to strongly agree), ordinal satisfaction scales (e.g., very satisfied to very dissatisfied), binary responses, and open-ended feedback. Responses are analysed descriptively to assess participant perceptions of the genetic risk disclosure and diagnostic process.","2 weeks after return of results (Study Visit 3) and 12 months (Study Visit 4)",{"measure":49,"description":50,"timeFrame":20},"Psychological impact of genetic disclosure: Assessment of Anxiety Symptoms (Health Anxiety Inventory)","Health anxiety symptoms assessed using the Health Anxiety Inventory (HAI). The HAI consists of multiple items assessing concerns about health and illness, with responses scored on a Likert-type scale and summed to generate a total score. Total scores range from 0 to 54, with higher scores indicating greater health-related anxiety.",{"measure":52,"description":53,"timeFrame":20},"Psychological impact of genetic disclosure: Assessment of Depression Symptoms (CES-D)","Depressive symptoms assessed using the Center for Epidemiologic Studies Depression Scale (CES-D). The CES-D includes 20 items assessing symptoms of depression over the past week. Total scores range from 0 to 60, with higher scores indicating greater depressive symptom severity.",{"measure":55,"description":56,"timeFrame":57},"Genetic Risk Perception and Understanding (IGT-AD Scale)","Genetic risk perception and understanding assessed using the REVEAL Impact of Genetic Testing in Alzheimer's Disease (IGT-AD) Scale. The questionnaire includes multiple items rated on a 4-point Likert scale ranging from 0 (never) to 5 (often). Item scores are summed to produce a total score, with higher scores indicating greater psychological impact or concern related to receiving genetic testing results.","12 months (Study Visit 4)",{"measure":59,"description":60,"timeFrame":61},"Per-Patient Cost of Biomarker Enabled Approach Implementation","Cost estimates per patient derived from resource requirements for blood collection, phlebotomy services, dried blood spot kits, biomarker laboratory analysis (PrecivityAD2 and epigenetic markers), genetic testing, and remote cognitive testing infrastructure.","Throughout study duration (up to 36 months), calculated from resource utilisation data",{"measure":63,"description":64,"timeFrame":65},"Diagnostic Efficiency Compared to Standard UK Practice","Time from GP referral to clinical diagnosis in study participants compared to standard UK practice using Clinical Practice Research Datalink (CPRD) data as the comparator.","Measured from baseline through Memory Clinic diagnosis (up to 12 months); compared to CPRD data throughout study duration (up to 36 months)",{"measure":67,"description":68,"timeFrame":69},"Quality-Adjusted Life Years (QALYs) Gained","Incremental quality-adjusted life-years gained due to earlier diagnosis and access to pharmacological (e.g., donepezil) and non-pharmacological care (e.g., dementia support workers, caregiver support), calculated from EQ-5D-5L data using health economic modeling.","Study duration (up to 36 months) with health economic modeling projecting outcomes over ≥10 years",{"measure":71,"description":72,"timeFrame":73},"Cost-Effectiveness by APOE4 Carrier Status (Subgroup Analysis)","Incremental cost-effectiveness results stratified by APOE4 carrier status (non-carrier, heterozygous carrier, homozygous carrier) to evaluate variability in outcomes and cost per QALY gained based on genetic risk category.","Throughout study duration (up to 36 months), with health economic modeling",{"measure":75,"description":76,"timeFrame":77},"Health Economic Model Robustness","Results of probabilistic sensitivity analyses and scenario analyses to quantify the impact of data uncertainty and structural model assumptions on cost-effectiveness estimates.","Throughout study duration (up to 36 months), with final analysis upon study completion",{"measure":79,"description":80,"timeFrame":81},"Healthcare Resource Utilisation","Healthcare resource utilisation following diagnostic evaluation, measured as the number of further investigations requested or avoided per participant (e.g., additional bloods, MRI, or other diagnostic tests), derived from a survey completed by the treating clinical team. The number of investigations are used to characterise healthcare resource use associated with the diagnostic pathway.","Throughout study duration (up to 36 months)",null,{"allocation":82,"interventionModel":82,"interventionModelDescription":82,"primaryPurpose":82,"observationalModel":84,"timePerspective":85,"maskingInfo":82},"COHORT","PROSPECTIVE","The SANDBOX study evaluates an approach to integrating blood-based biomarkers, APOE4 genetic testing, and digitally administered cognitive assessments into Memory Clinic diagnostic pathways. The primary aim is to assess whether this approach improves efficiency of dementia diagnosis and patient flow through Memory Clinic services.\n\nParticipants will undergo baseline assessment including venous blood draw (42.5 mL) for analysis of plasma phosphorylated tau-217, epigenetic markers in cell-free DNA, and APOE4 genotyping. Dried blood spot samples will be collected via finger-prick.\n\nDigital cognitive testing will be conducted using CANTAB (Cambridge Neuropsychological Test Automated Battery) and recorded speech analysis.\n\nBlood biomarker and genetic results will be withheld from clinical teams until participants have a Memory Clinic appointment scheduled, to prevent bias in triage decisions. Results will then be shared with clinicians to support diagnostic assessment. All participants will be offered genetic counseling regarding APOE4 status.\n\nA follow-up assessment occurs at 12 months (repeat blood draws and cognitive testing). Psychological impact of genetic disclosure will be monitored using validated questionnaires (Health Anxiety Inventory, CES-D, EQ-5D-5L, IGT-AD Scale).\n\nHealth economic analysis will evaluate cost-effectiveness of the triage system compared to standard UK practice. AI-based exploratory analyses will investigate relationships between biomarkers and dementia progression.","Adults aged 50 years or older with subjective or objective cognitive impairment who have been referred to Memory Clinics for diagnostic clarification. Participants are recruited from Memory Clinic waiting lists across multiple NHS sites in England and Wales and are awaiting secondary care assessment for memory concerns. The study population includes individuals experiencing cognitive difficulties but without a prior dementia diagnosis.",[89,94],{"name":90,"role":91,"phone":92,"phoneExt":82,"email":93},"Victoria B Medina, MRes","CONTACT","+447493339995","victoria@primamente.com",{"name":95,"role":91,"phone":82,"phoneExt":82,"email":96},"Hayley Holt, PhD","hayley@primamente.com",[98,120,133,146,160,177,193,213,223,239,257,273],{"facility":99,"status":100,"city":101,"state":102,"zip":103,"country":104,"countryCode":105,"cosmosGeoPoint":106,"geoPoint":111,"contacts":112},"Imperial College Healthcare NHS Trust","RECRUITING","London","Greater London","W6 8RF","United Kingdom","UK",{"type":107,"coordinates":108},"Point",[109,110],-0.12574,51.50853,{"lat":110,"lon":109},[113,117],{"name":114,"role":91,"phone":115,"phoneExt":82,"email":116},"Rylie Johnson","+44 2033115228","rylie.johnson@nhs.net",{"name":118,"role":119,"phone":82,"phoneExt":82,"email":82},"Richard Perry","PRINCIPAL_INVESTIGATOR",{"facility":121,"status":100,"city":101,"state":101,"zip":122,"country":104,"countryCode":105,"cosmosGeoPoint":123,"geoPoint":125,"contacts":126},"Central and North West London NHS Foundation Trust","NW5 3EG",{"type":107,"coordinates":124},[109,110],{"lat":110,"lon":109},[127,131],{"name":128,"role":91,"phone":129,"phoneExt":82,"email":130},"Joe Gilbert","+44 07858679543","joe.gilbert2@nhs.net",{"name":132,"role":119,"phone":82,"phoneExt":82,"email":82},"Guy Harman",{"facility":134,"status":100,"city":101,"state":101,"zip":135,"country":104,"countryCode":105,"cosmosGeoPoint":136,"geoPoint":138,"contacts":139},"West London NHS Trust","UB1 3HW",{"type":107,"coordinates":137},[109,110],{"lat":110,"lon":109},[140,144],{"name":141,"role":91,"phone":142,"phoneExt":82,"email":143},"Petya Apostolova","+44 07517 988317","petya.apostolova1@nhs.net",{"name":145,"role":119,"phone":82,"phoneExt":82,"email":82},"Malgorzata Raczek",{"facility":147,"status":100,"city":101,"state":148,"zip":149,"country":104,"countryCode":105,"cosmosGeoPoint":150,"geoPoint":152,"contacts":153},"Surrey and Borders Partnership NHS Foundation Trust","Surrey","KT22 7AD",{"type":107,"coordinates":151},[109,110],{"lat":110,"lon":109},[154,158],{"name":155,"role":91,"phone":156,"phoneExt":82,"email":157},"Aisling Quinn","01372 216584","Aisling.Quinn@sabp.nhs.uk",{"name":159,"role":119,"phone":82,"phoneExt":82,"email":82},"Ramin Nilforooshan",{"facility":161,"status":100,"city":162,"state":163,"zip":164,"country":104,"countryCode":105,"cosmosGeoPoint":165,"geoPoint":169,"contacts":170},"Aneurin Bevan University Health Board Clinical Research Centre","Newport","Wales","NP20 2UB",{"type":107,"coordinates":166},[167,168],-2.99835,51.58774,{"lat":168,"lon":167},[171,175],{"name":172,"role":91,"phone":173,"phoneExt":82,"email":174},"Heeam Nassa","01633 238480","ABB.RandD@wales.nhs.uk",{"name":176,"role":119,"phone":82,"phoneExt":82,"email":82},"Chineze Ivenso",{"facility":178,"status":100,"city":179,"state":82,"zip":180,"country":104,"countryCode":105,"cosmosGeoPoint":181,"geoPoint":185,"contacts":186},"Bradford District Care Foundation Trust","Bradford","BD9 6DP",{"type":107,"coordinates":182},[183,184],-1.75206,53.79391,{"lat":184,"lon":183},[187,191],{"name":188,"role":91,"phone":189,"phoneExt":82,"email":190},"Ireen Mumba","+44 07385113354","ireen.mumba@bdct.nhs.uk",{"name":192,"role":119,"phone":82,"phoneExt":82,"email":82},"Gregor Russell",{"facility":194,"status":100,"city":195,"state":82,"zip":196,"country":104,"countryCode":105,"cosmosGeoPoint":197,"geoPoint":201,"contacts":202},"Cwm Taf Morgannwg University Health Board","Bridgend","CF31 1RQ",{"type":107,"coordinates":198},[199,200],-3.57722,51.50583,{"lat":200,"lon":199},[203,207,211],{"name":204,"role":91,"phone":205,"phoneExt":82,"email":206},"Cerys Evenden","+44 01656 752477","Cerys.Evenden@wales.nhs.uk",{"name":208,"role":91,"phone":209,"phoneExt":82,"email":210},"Eleanor James","+44 01685 728803","Eleanor.James@wales.nhs.uk",{"name":212,"role":119,"phone":82,"phoneExt":82,"email":82},"Mridul Biswas",{"facility":214,"status":215,"city":216,"state":82,"zip":217,"country":104,"countryCode":105,"cosmosGeoPoint":218,"geoPoint":222,"contacts":82},"Hywel Dda University Health Board","ACTIVE_NOT_RECRUITING","Llanelli","SA148QF",{"type":107,"coordinates":219},[220,221],-4.16191,51.68195,{"lat":221,"lon":220},{"facility":224,"status":100,"city":225,"state":82,"zip":226,"country":104,"countryCode":105,"cosmosGeoPoint":227,"geoPoint":231,"contacts":232},"Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust","Newcastle upon Tyne","NE4 5PL",{"type":107,"coordinates":228},[229,230],-1.61396,54.97328,{"lat":230,"lon":229},[233,237],{"name":234,"role":91,"phone":235,"phoneExt":82,"email":236},"Claire Airey","07974 096892","Claire.airey@cntw.nhs.uk",{"name":238,"role":119,"phone":82,"phoneExt":82,"email":82},"Meher Lad",{"facility":240,"status":100,"city":241,"state":82,"zip":242,"country":104,"countryCode":105,"cosmosGeoPoint":243,"geoPoint":247,"contacts":248},"Cardiff and Vale University Health Board","Penarth","CF64 2XX",{"type":107,"coordinates":244},[245,246],-3.17342,51.4386,{"lat":246,"lon":245},[249,253,255],{"name":250,"role":91,"phone":251,"phoneExt":82,"email":252},"Matthew Forrester","+44 02921826908","Matthew.Forester@wales.nhs.uk",{"name":254,"role":119,"phone":82,"phoneExt":82,"email":82},"Biju Mohamed",{"name":256,"role":119,"phone":82,"phoneExt":82,"email":82},"Cherry Shute",{"facility":258,"status":100,"city":259,"state":82,"zip":260,"country":104,"countryCode":105,"cosmosGeoPoint":261,"geoPoint":265,"contacts":266},"Berkshire Healthcare NHS Foundation Trust","Reading","RG6 7BE",{"type":107,"coordinates":262},[263,264],-0.97113,51.45625,{"lat":264,"lon":263},[267,271],{"name":268,"role":91,"phone":269,"phoneExt":82,"email":270},"Mathew Baker","+44 07411339048","research@berkshire.nhs.uk",{"name":272,"role":119,"phone":82,"phoneExt":82,"email":82},"Rohan Vanderputt",{"facility":274,"status":100,"city":275,"state":82,"zip":276,"country":104,"countryCode":105,"cosmosGeoPoint":277,"geoPoint":281,"contacts":282},"Swansea Bay University Health Board","Swansea","SA2 8PP",{"type":107,"coordinates":278},[279,280],-3.94323,51.62079,{"lat":280,"lon":279},[283,287,291],{"name":284,"role":91,"phone":285,"phoneExt":82,"email":286},"Caradog Thomas","+44 01792957587","caradog.thomas@wales.nhs.uk",{"name":288,"role":91,"phone":289,"phoneExt":82,"email":290},"Alison Blows","+44 01792 957588","Alison.Blows@wales.nhs.uk",{"name":292,"role":119,"phone":82,"phoneExt":82,"email":82},"Jaya Ramachandran",{"type":119,"investigatorFullName":294,"investigatorTitle":295,"investigatorAffiliation":296,"oldNameTitle":82,"oldOrganization":82},"Ivan Koychev","Dr Ivan Koychev","Imperial College London","100657638","evaluation-of-blood-based-biomarkers-and-remote-cognitive-assessment-for-dementia-triage-sandbox-100657638",false,"NCT07842029","Evaluation of Blood-Based Biomarkers and Remote Cognitive Assessment for Dementia Triage (SANDBOX)","SANDBOX: Scalable Assessment of Neurodegenerative Diagnosis Via Biomarkers and Online Examination","SANDBOX","Inclusion Criteria:\n\n* The participant is willing and able to provide informed consent for participation in the study, or if unable to consent, a consultee (nearest of kin or holder of Power of Attorney) is available to make a declaration.\n* Eligibility for recruitment in Scotland is restricted to participants who are able to provide informed consent themselves; participants requiring consultee consent will not be recruited in Scotland.\n* Male or female, aged 50 years or older.\n* The participant is currently on a waiting list for a participating Memory Clinic.\n* The participant lives within traveling distance to a study site.\n* The participant agrees to complete all study procedures, including genetic testing.\n\nExclusion Criteria:\n\n* The participant may not enter the study if any of the following criteria apply:\n* The participant has known or anticipated challenges with venous blood sampling.\n* The participant is not fluent in English.\n* The participant has a historical diagnosis of dementia.","ALL","50 Years",{"count":308,"type":309},1000,"ESTIMATED","OBSERVATIONAL","Dementia is a leading cause of death in the UK, and long waits for diagnosis can delay access to care and treatment. The SANDBOX study is a research study in NHS Memory Clinics investigating whether providing clinicians with additional test results could help them diagnose dementia earlier.\n\nAdults aged 50 or over who have been referred to a Memory Clinic by their GP may be invited to take part. Taking part is voluntary and will not affect a participant's care. Participation adds to their NHS care and does not replace or delay it.\n\nParticipants complete three assessments: a blood test that measures two proteins which can indicate whether Alzheimer's-related changes may be happening in the brain (not currently available on the NHS); a genetic test for the APOE gene, which influences Alzheimer's risk; and a cognitive assessment of memory and thinking that includes a recorded speech task analysed for subtle language changes. All results are shared with the participant's clinician.\n\nThis research will help determine whether this approach can support earlier dementia diagnosis and improve care for patients across the UK.",[313,314],"Dementia","Cognitive Impairment",[303,316,317,318,319,320],"dementia","cognitive impairment","cognitive decline","Alzheimer's","Neurodegeneration","2026-09-21",{"date":323,"type":324},"2026-09-25","ACTUAL",{"date":326,"type":324},"2025-11-13",{"date":328,"type":309},"2027-11-30",{"name":5,"class":6},12]