[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"major-neurocognitive-disorder\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:major-neurocognitive-disorder":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,52,80,106,138],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":23,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100570006","italian-adaptation-and-validation-of-functional-and-behavioural-scales-for-subjective-cognitive-decline-mild-cognitive-impairment-and-mild-dementia-100570006",false,"NCT06701630","Italian Adaptation and Validation of Functional and Behavioural Scales for Subjective Cognitive Decline, Mild Cognitive Impairment and Mild Dementia.","Functional and Behavioural Scales Validation in Italian.","ITA-VALI-DEM","Inclusion Criteria:\n\n* Age ≥ 60 years;\n* Availability of an informant\u002Fcaregiver, able to judge their functional abilities.\n\nFor neurologically unimpaired elderly:\n\n\\- Normal performance on the Mini Mental State Examination (Folstein et al. 1975; Foderaro et al., 2022).\n\nFor clinical groups: Conditions consistent with:\n\n* Subjective Cognitive Decline (Jessen et al., 2014)\n* Mild Cognitive Impairment (Winblad et al., 2004)\n* Mild Major Neurocognitive Disorder according (DSM-5-TR, APA, 2022).\n\nExclusion Criteria:\n\n* Refusal or inability to sign informed consent;\n* For the clinical groups: other neurological or psychiatric conditions that may explain the presence of cognitive difficulties.",true,"ALL","60 Years",{"count":21,"type":22},390,"ESTIMATED","1 Day","OBSERVATIONAL","The first aim of the observational study is the translation, cross-cultural adaptation and validation of functional and behavioral scales used in the diagnosis of neurodegenerative diseases, for which a formal version in Italian is not available at present. In particular, the study includes the following functional and behavioral scales: the Katz's index (Basic Activities of Daily Living, BADL), the Lawton and Brody's scale (Instrumental Activities of Daily Living, IADL), the Everyday Cognition questionnaire (E-Cog), the Neuropsychiatric Inventory Questionnaire (NPI-Q) for assessing the Behavioral and Psychological Symptoms of Dementia. Furthermore, a modified Italian version of the Functional Activities Questionnaire (FAQ), which integrates and updates the content of the original items (e.g., addressing the use of technologies, M-FAQ) will be used in the validation study.\n\nThe second aim is to evaluate the psychometric properties of the M-FAQ, the ECog, and the NPI-Q in terms of reliability and validity.\n\nThe third aim is to apply a Receiver Operating Characteristic (ROC) curve analysis to identify cut-offs of IADL, M-FAQ and ECOG to discriminate between different clinical groups (i.e., neurologically unimpaired elderly; Subjective Cognitive Decline, SCD; Mild Cognitive Impairment, MCI; mild Alzheimer's Disease, AD).\n\nNeurologically unimpaired elderly participants (over 60 years old) and participants with SCD, MCI, mild AD, and their caregivers\u002Finformants will undergo: i) administration of the translated versions of the scales; ii) administration of a Cognitive Reserve questionnaire. For SCD, MCI and AD participants, data from the clinical neuropsychological evaluation will also be collected, while paper-and-pencil psychometric tests to assess global cognitive functioning (Mini Mental State Examination) and logical-abstract reasoning (Raven's Colored Matrices) will be administered to the neurologically unimpaired participants.",[27,28,29,30],"Neurologically Unimpaired Elderly Participants","Subjective Cognitive Decline (SCD)","Mild Cognitive Impairment (MCI)","Major Neurocognitive Disorder",[32,33,34,35,36,37,38],"BADL and IADL","FAQ scale","ECog","NPI-Q","Italian adaptation","Validation","Functional and behavioral scales","RECRUITING","2025-02-11",{"date":42,"type":43},"2025-02-13","ACTUAL",{"date":45,"type":43},"2024-11-26",{"date":47,"type":22},"2026-11-30",{"name":49,"class":50},"Casa di Cura IGEA","OTHER",1,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":51},"100564635","exergaming-revolution-in-dementia-100564635","NCT06631742","Exergaming Revolution in Dementia","The Effect of an Exergaming Intervention on Physical Activity and Sleep in People With Major Neurocognitive Disorders Living in Long-term Care Facilities: a Pilot Randomized Controlled Trial.","GameDementia","Inclusion Criteria:\n\n* Neurocognitive disorder based on Alzheimer's Disease, Parkinson's disease, Lewy body dementia or Mixed dementia according to the criteria of the American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5)\n* Mini-Mental-Status-Examination (MMSE) Score of ≥5 and ≤26 out of e maximum of 30\n\nExclusion Criteria:\n\n* MMSE \\\u003C5\n* Unstable cardiovascular condition or other medical condition that does not allow for safe participation according to the recommendations of the American College of Sports Medicine\n* Planned transfer to another facility within the next 3 months\n* Acute behavioural problems",{"count":61,"type":22},48,"INTERVENTIONAL",[64],"NA","This pilot randomized controlled trial evaluates the effect of a 12 weeks exergaming training in people with major neurocognitive disorders (MNCD) living in long-term care facilities.",[30,67,68,69,70],"Alzheimer Disease","Parkinson Disease","Lewy Body Dementia","Mixed Dementias","2024-10-07",{"date":73,"type":43},"2024-10-08",{"date":75,"type":43},"2024-09-27",{"date":77,"type":22},"2027-04-30",{"name":79,"class":50},"Eastern Switzerland University of Applied Sciences",{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":18,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":4,"studyType":62,"phases":91,"briefSummary":92,"conditions":93,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":105},"100563361","confirmatory-clinical-trial-for-verifying-the-efficacy-and-safety-of-alzguard-as-a-digital-dementia-diagnostic-aid-tool-for-the-diagnosis-of-the-major-neurocognitive-disorders-100563361","NCT06615167","Confirmatory Clinical Trial for Verifying the Efficacy and Safety of 'ALZGUARD' as a Digital Dementia Diagnostic Aid-Tool for the Diagnosis of the Major Neurocognitive Disorders","A Single-blind (Data Analyst 1), Single-arm Design, Prospective, Multi-center Confirmatory Clinical Trial for Verifying the Efficacy and Safety of 'ALZGUARD' as a Digital Dementia Diagnostic Aid-Tool for the Diagnosis of the Major Neurocognitive Disorders According to DSM-5","Inclusion Criteria:\n\n* Participants must be between 55 and 85 years old (both men and women).\n* Participants must be able to understand and voluntarily agree to the purpose, content, and procedures of the clinical trial.\n\nExclusion Criteria:\n\n* Participants with no literacy or illiteracy.\n* Participants with an intellectual disability.\n* Participants with presenting active psychiatric symptoms.\n* Participants who have difficulty ALZGUARD application\n* Participants who are unable to use a smartphone, unless they can use it with assistant.\n* Participants with a history of suicidal ideation or suicidal complusion in the last 6 months.\n* Other conditions as deemed inappropriate for study participant by the Principal Investigator(PI).","55 Years","85 Years",{"count":90,"type":22},122,[64],"The goal of this clinical trial is to evalute the efficacy of ALZGUARD, a smartphone-based digital therapeutic(DTx), in comparison to diagnosis by medical doctors, as weel as to assess the safety of the application.",[94,30],"Dementia","2024-09-25",{"date":97,"type":43},"2024-09-26",{"date":99,"type":43},"2024-09-12",{"date":101,"type":22},"2025-04-30",{"name":103,"class":104},"HAII corp.ltd","INDUSTRY",3,{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":18,"minAge":113,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":62,"phases":116,"briefSummary":117,"conditions":118,"keywords":119,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":137},"100430800","gps-project-evaluation-of-the-impact-of-the-reorganization-of-work-into-a-family-medicine-group-on-pharmacotherapy-and-support-for-the-autonomy-of-seniors-with-major-neurocognitive-disorders-100430800","NCT04889794","GPS Project Evaluation of the Impact of the Reorganization of Work Into a Family Medicine Group on Pharmacotherapy and Support for the Autonomy of Seniors With Major Neurocognitive Disorders","GPS Project - Evaluation of the Impact of the Reorganization of Work Into a Family Medicine Group on Pharmacotherapy and Support for the Autonomy of Seniors With Major Neurocognitive Disorders","Inclusion Criteria:\n\n* All seniors (65 years of age or older) undergoing cognitive evaluation OR referred to a memory clinic OR having been diagnosed with cognitive impairment within the last year OR with MCND and followed up at home AND,\n* referred to the pharmacist, for the FMGs exposed\n* taking prescription medications\n\nExclusion Criteria:\n\n* Seniors in palliative care OR\n* unable to answer questionnaires in French AND without a caregiver.","65 Years",{"count":115,"type":22},400,[64],"The model of care tested in the GPS project aims to optimize pharmacotherapy for seniors undergoing cognitive assessment or suffering from major neurocognitive disorder (MCND) at home. The goal is to reduce polymedication, inappropriate medications and the treatment burden of seniors and to maintain their cognitive health, quality of life and autonomy. The intervention will include knowledge exchange sessions with nurses, pharmacists, and doctors in FMGs, and increased collaboration between these professionals and home care services teams. Other goal is to increase the satisfaction of the seniors, their families, and the professionals involved in the GPS project.",[30],[120,121,122,123,124,125,126,127],"living lab","major neurocognitive disorder","polypharmacy","health outcomes","pharmacists","home care","family medicine groups","deprescribing","2024-08-20",{"date":130,"type":43},"2024-08-22",{"date":132,"type":43},"2021-09-27",{"date":134,"type":22},"2026-12",{"name":136,"class":50},"CHU de Quebec-Universite Laval",2,{"id":139,"slug":140,"hasResults":11,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":4,"eligibilityCriteria":144,"healthyVolunteers":11,"sex":18,"minAge":113,"maxAge":4,"enrollmentInfo":145,"targetDuration":4,"studyType":62,"phases":147,"briefSummary":148,"conditions":149,"keywords":150,"overallStatus":155,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":51},"100559063","tdcs-as-augmentation-therapy-to-cognitive-training-in-mild-dementia-100559063","NCT06559254","TDCS as Augmentation Therapy to Cognitive Training in Mild Dementia","Randomized Controlled Trial of Transcranial Direct Current Stimulation (tDCS) as Augmentation Therapy to Cognitive Training (CT) in Individuals With Major Neurocognitive Disorder (MND) of Mild Severity","Inclusion Criteria:\n\n* 65 years of age or above\n* Right-handedness Chinese as defined by Edinburgh handedness inventory\n* Cantonese speaking\n* Fulfil the criteria of Major neurocognitive disorder, as defined by the 5 th Edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM- 5)\n* Clinical Dementia Rating Global score = 1\n\nExclusion Criteria:\n\n* Active diagnosis of mood disorder or psychosis\n* Alcohol or substance dependence\n* Initiation or change in dose of cognitive enhancer within 6 months prior to the onset of the study 14\n* Poor physical condition and mobility\n* Having regular cognitive training (as defined by at least three 1-hour weekly structured and standardized cognitive training in recent 3 months) 15\n* Receiving tDCS within 2 months prior to the onset of study 16\n* Significant communication or visual impairment\n* Having metal implant in area above upper back, or having metal crown or metal brace, or pacemaker",{"count":146,"type":22},36,[64],"Due to increase in life expectancy, major neurocognitive disorder (MND) becoming increasingly important as reflected in the increasing number in dementia population, as well as in burden to health care system and to caregiver.\n\nAmong current treatment, cognitive training has shown to have significant outcome in cognitive impaired patient. But the effect is reported to be small and might not be long-lasting. In consideration of the neuronal excitability effect in tDCS, it may consolidate the effect of cognitive training if used simultaneously. The study will investigate on efficacy of tDCS as combined intervention to cognitive training.\n\nThe study aims to investigate the efficacy of 2-week (5 sessions per week) tDCS to augment cognitive training in subjects with MND with clinically mild severity. Patients with diagnosis of MND or dementia from HKWC will be recruited with inclusion and exclusion criteria listed. The eligible participants will be randomized to receive either active intervention (active tDCS) or sham (sham tDCS) as control with cognitive training simultaneously.\n\nEach session lasts for 20 minutes. The subjects will be allocated to either interventional or control group using block randomization. Block of 4 will be used to allocate subjects at 1:1 ratio between two groups. Both the participants and investigators responsible for assessment and data analysis will be blinded to the group allocation. Primary and secondary outcome will be assessed at baseline, week 2 (after course of intervention) and 4 weeks after the course of intervention. Baseline assessment assesses on demographic data (e.g. age, gender, years of education), clinical data with full psychiatric assessment and access to previous medical record, neuropsychiatric data (HK-MoCA and CNPI). Primary outcomes includes N-back (cognitive training) performance, forward and backward digit span. Secondary outcomes includes measurement on dementia rating and trail making test. In data analysis, any group differences in demographics and clinical profiles between the intervention and sham group at baseline will be assess. ANOVA will be performed to examine the effect of time and intervention on primary outcome and other cognitive assessment across time points. Potential confounders will be adjusted.\n\nBaseline assessments and outcome measures is either psychiatric assessment, clinician rating scales or cognitive assessment performed with investigator.",[30],[151,121,152,153,154],"mild dementia","tdcs","transcranial direct current stimulation","cognitive training","NOT_YET_RECRUITING","2024-08-14",{"date":158,"type":43},"2024-08-19",{"date":160,"type":22},"2024-09-01",{"date":162,"type":22},"2025-09-30",{"name":164,"class":165},"Hospital Authority, Hong Kong","OTHER_GOV"]