[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mild-cognitive-impairment-mci\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mild-cognitive-impairment-mci":27},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,131,0,25,[9,56,85,120,151,177,200,224,250,270,292,320,354,379,400,426,452,492,514,537,562,588,608,637,664],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100609370","inrad-observational-study-100609370",false,"NCT07213700","InRAD Observational Study","The International Registry for Alzheimer's Disease and Other Dementias (InRAD): An International Registry Observational Study Dedicated to Evaluating Outcomes Data in Alzheimer's Disease","InRAD","Inclusion Criteria:\n\n* Be undergoing diagnostic work-up for Alzheimer's disease (AD), OR\n* Have a confirmed diagnosis of AD (whether currently treated with an AD-specific treatment, or untreated),\n* Be attending an InRAD Center,\n* Have provided informed consent for long-term follow-up\n\nExclusion Criteria:\n\n-Any patient or legal representative who is unable or unwilling to provide a signed informed consent form","ALL",{"count":20,"type":21},50000,"ESTIMATED","10 Years","OBSERVATIONAL","The goal of this international observational study is to evaluate long-term disease outcomes and treatment safety in people with Alzheimer's disease (PwAD), by collecting real-world data from routine clinical practice across global clinical centers.\n\nThe InRAD Registry Observational Study has several aims:\n\n* To collect medical information for many years from a large group of people with Alzheimer's disease. This will be used for research, which will support improved understanding about the disease.\n* To enable researchers to look at the effectiveness, usefulness and safety of treatments for Alzheimer's disease.\n* To enable researchers to answer similar research questions and compare results in many different areas of the world.\n\nPeople with Alzheimer's disease who meet the eligibility criteria and agree to participate in the Study will be asked to visit their doctor (e.g. psychiatrist, geriatrician, or neurologist) at least once a year, or as frequently as is needed for their care. During or after their appointments they may be offered assessments, tests, medications, and treatments as determined by their doctor and their team. This is an observational data collection.",[26,27,28,29],"Alzheimer's Disease(AD)","Mild Cognitive Impairment (MCI)","Subjective Cognitive Decline (SCD)","Non-Alzheimer Degenerative Dementia",[31,32,33,34,35,36,37,38,39,40,41,42],"Alzheimer's disease (AD)","Dementia","Observational study","Real-world data (RWD)","International registry","Cognitive decline","Lecanemab","InRAD Registry","InRAD Foundation","Cognitive screening (MoCA, MMSE)","AD-specific therapies","Clinical staging","RECRUITING","2026-08-20",{"date":46,"type":47},"2026-08-21","ACTUAL",{"date":49,"type":47},"2026-03-30",{"date":51,"type":21},"2036-01",{"name":53,"class":54},"Stichting International Registry for Alzheimer's Disease and other Dementias Foundation","OTHER",12,{"id":57,"slug":58,"hasResults":12,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":4,"eligibilityCriteria":62,"healthyVolunteers":12,"sex":18,"minAge":63,"maxAge":4,"enrollmentInfo":64,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":66,"conditions":67,"keywords":70,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":84},"100652857","wearable-sensor-for-early-detection-and-monitoring-of-cognitive-decline-100652857","NCT07780162","Wearable Sensor for Early Detection and Monitoring of Cognitive Decline","A MULTI-MODAL WEARABLE SENSOR FOR EARLY DETECTION OF COGNITIVE DECLINE AND REMOTE MONITORING OF COGNITIVE-MOTOR DECLINE OVER TIME","Inclusion Criteria:\n\n* Adults age 55 years or older\n* Ambulatory (able to walk 40 feet with or without walking assistance)\n* Willing and able to provide informed consent.\n* Individuals in the cognitive impairment group, should either have a diagnosis of cognitive impairment, a MoCA score of 25 or lower, or be confirmation of cognitive impairment by the Principal Investigator or clinical collaborators based on self-reported memory problems and relevant patient history. Individuals in the non-cognitively impaired group must have a MoCA score of 26 or higher.\n\nExclusion Criteria:\n\n* Children and younger adults: We exclude children and younger adults (younger than 55 years old) as dementia and cognitive-motor impairment is anticipated to be lower among those younger than 55.\n* Immobility or major mobility disorder: We will exclude those who were bedbound or unable to stand or ambulate with or without walking assistance (e.g., cane, walker) that prohibit them from performing the 40-foot walking test needed for the Fried Frailty Criteria.\n* Pre-existing acute conditions: We will exclude those with acute or unstable conditions (e.g., fractures) that may significantly affect gait and balance, according to the judgement of clinical investigators. In addition, we will exclude those with any significant medical or psychiatric condition that, in the judgment of the investigators, would potentially interfere with the ability to participate in the study.\n* Medication: Changes in medication regime unrelated to dementia or those taken temporarily that may affect balance and\u002For gait (e.g., narcotic, anxiety medication) based on judgement of our clinical investigators.\n* Severe vision, aphasia, or healing problems: We will exclude those with major hearing, aphasia, or visual problems, which may limit their ability to complete patient-reported outcomes, complete the cognitive screening assessments, and may impact Dual Task physical activities. Those with corrected vision or hearing problems (e.g., using prescription glasses, hearing aids, etc.) will be included.\n* Ongoing treatment: We will exclude those receiving active therapy (e.g., undergoing active chemotherapy or radiotherapy).\n* Lack of capacity to consent.\n* Other exclusion criteria include the inability to use telemedicine (e.g., no internet at home, severe visual or hearing problem, lack of caregiver support, etc.); inability or unwillingness to participate in scheduled in clinic visits (e.g., living farther than 30 miles from the clinic, unavailability of caregivers). We will also exclude those with significant cognitive impairment (MoCA score\\\u003C16), severe dementia, severe apathy, severe aphasia or speaking problems, severe depression, those who are on hospice care or palliative care, those with severe pain, and with history of drug or alcohol abuse over the last six months. Finally, we will exclude those who are unable to communicate in English or are unlikely to fully comply with the follow-up protocol (e.g., long travel distance).","55 Years",{"count":65,"type":21},100,"This observational study will enroll approximately 100 participants evenly split by cognitive status (Cognitively Impaired vs Non-Cognitively Impaired), and involves four clinic visits over one year (at baseline, 3, 6, and 12 months), each followed by 7 days of remote monitoring to assess the long-term feasibility of PAMSys+ (Physical Activity Monitoring System).",[27,68,69],"Older Adults With Cognitive Decline","Older Adults",[71,72,73],"digital health","wearable sensors","mild cognitive impairment","NOT_YET_RECRUITING","2026-08-19",{"date":46,"type":47},{"date":78,"type":21},"2026-12-15",{"date":80,"type":21},"2030-03-30",{"name":82,"class":83},"BioSensics","INDUSTRY",1,{"id":86,"slug":87,"hasResults":12,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":93,"sex":18,"minAge":94,"maxAge":95,"enrollmentInfo":96,"targetDuration":4,"studyType":98,"phases":99,"briefSummary":101,"conditions":102,"keywords":104,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":113,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":84},"100652741","comparative-effects-of-integrated-versus-sequential-approaches-to-dual-task-training-in-elderly-with-mild-to-moderate-cognitive-impairment-a-four-arm-randomized-controlled-trial-100652741","NCT07775079","Comparative Effects of Integrated Versus Sequential Approaches to Dual-Task Training in Elderly With Mild to Moderate Cognitive Impairment","Comparative Effects of Integrated Versus Sequential Approaches to Dual-Task Training in Elderly With Mild to Moderate Cognitive Impairment: A Four-Arm Randomized Controlled Trial","nill","Inclusion Criteria:\n\n* Age \\> 55 years\n* MoCA: 10-25\n* MMSE: 10-23\n* Diagnosed cognitive impairment\n* Able to participate in training\n\nExclusion Criteria:\n\n* Severe cognitive impairment\n* Severe physical sensory limitations\n* Unstable medical conditions\n* Participation in other trials",true,"55 Months","85 Months",{"count":97,"type":21},96,"INTERVENTIONAL",[100],"NA","Mild and Moderate cognitive impairment is a condition characterized by a noticeable decline in cognitive abilities, including memory and thinking skills, which is greater than expected for an individual's age but does not significantly interfere with daily life. Early intervention is essential to prevent further cognitive decline and progression to dementia.\n\nDual-task training has emerged as an effective rehabilitation approach that combines cognitive and motor tasks to enhance neuroplasticity and improve both physical and cognitive performance. This study is designed to investigate the effectiveness of dual-task training compared to conventional therapy in individuals with mild cognitive impairment.\n\nParticipants meeting the inclusion criteria will be recruited and randomly allocated into intervention and control groups. The intervention group will receive structured dual-task training, which may include activities such as walking while performing cognitive tasks (e.g., counting, word recall), balance exercises combined with mental tasks, and functional activities requiring divided attention. The control group will receive standard rehabilitation or single-task training.\n\nThe intervention will be conducted over a specified duration (e.g., several weeks), with sessions held multiple times per week. Outcome measures will be assessed at baseline and after completion of the intervention. The primary outcome will be cognitive function measured using the Mini-Mental State Examination (MMSE). Secondary outcomes may include balance, mobility, and functional performance.\n\nData will be analyzed to determine the effectiveness of dual-task training in improving cognitive and functional outcomes. The results of this study may contribute to evidence-based rehabilitation practices and support the use of dual-task interventions in clinical settings.",[27,103],"Moderate Cognitive Impairment",[105,106,107,108,109,110,111,112],"Dual-task training","Cognitive Function","Rehabilitation","MMSE","MoCA","Balance training","Integrated training","Sequential training",{"date":46,"type":47},{"date":115,"type":47},"2026-06-25",{"date":117,"type":21},"2026-08-30",{"name":119,"class":54},"Shifa Tameer-e-Millat University",{"id":121,"slug":122,"hasResults":12,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":4,"eligibilityCriteria":126,"healthyVolunteers":12,"sex":18,"minAge":127,"maxAge":4,"enrollmentInfo":128,"targetDuration":4,"studyType":98,"phases":130,"briefSummary":131,"conditions":132,"keywords":135,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":84},"100588956","creatine-and-resistance-training-in-older-adults-with-mild-cognitive-impairment-100588956","NCT06948149","Creatine and Resistance Training in Older Adults With Mild Cognitive Impairment","Examining the Effects of Creatine Supplementation and Resistance Training on Cognition and Brain Health in Older Adults With Mild Cognitive Impairment: a 26 Week Randomized Controlled Trial","We will include participants who: 1) are aged \\>60; 2) are living independently in the community; 3) have normal or corrected-to-normal vision and hearing; 4) read, write, and speak English fluently; 5) are right-handed (if participating in the MRI component); 6) have subjective feelings of memory decline in the past five years; 7) have telephone Montreal Cognitive Assessment (T-MoCA) scores \\\u003C19\u002F22; 8) have high independence, as indicated by Instrumental Activities of Daily Living (IADL) scale \\>6\u002F8; 9) have a Geriatric Depression Scale (GDS) score \\\u003C6\u002F15; 10) are able to exercise at a moderate pace using resistance training for 60 minutes 3x\u002Fweek; and 11) receive clearance from a physician to participate in an exercise program at baseline.\n\nWe will exclude participants who: 1) cannot partake or commit to exercise training 3x\u002Fweek for 26 weeks or have engaged in resistance training \\>1x\u002Fweek over the past three months; 2) cannot partake or commit to consuming a daily supplement for 26 weeks or have consumed nutritional supplements containing creatine monohydrate over the past three months; 3) have a known allergy to creatine monohydrate or dextrose; 4) have been diagnosed with a neurological disorder (e.g., Alzheimer's disease, Parkinson's disease); 5) have pre-existing kidney disease, heart disease, or liver abnormalities; 6) have one or more uncontrolled chronic or psychiatric conditions (e.g., hypertension, diabetes, depression, anxiety); 7) are taking medication that may impact kidney function (e.g., non-steroidal anti-inflammatory drugs, such as ibuprofen and naproxen); or 8) are ineligible or uncomfortable with blood sampling.","60 Years",{"count":129,"type":21},140,[100],"The goal of this 26-week trial is to learn if creatine supplementation and resistance training (i.e., weightlifting; exercise that increases muscle mass), alone and together, impact cognition, brain health, and physical function in older adults with mild cognitive impairment. Previous studies have shown that resistance training improves cognition and brain health in older adults. Creatine is naturally occurring in the human body and is known to decline with age. Studies have shown that creatine increases muscle mass and bone density in older adults when supplemented. Some research has suggested that creatine may also improve cognition and brain health. However, little is known about how creatine supplementation affects the aging brain and body alone and when combined with resistance training, especially in those with known cognitive impairment.\n\nIn this study, participants will be randomly assigned to one of four groups: 1) creatine and resistance training, 2) placebo and resistance training, 3) creatine and active control (balance and tone classes), or 4) placebo and active control. Participants in the creatine groups will take creatine every day during the study. Participants in the placebo groups will take a look-alike substance that contains no drug every day during the study. Participants in the resistance training groups will attend three 60-minute classes per week that target each major muscle group and will increase in difficulty during the study. Participants in the active control group will attend three 60-minute classes per week that will consist of balance, stretching, and range of motion exercises. This group accounts for variables such as physical training received by traveling to the training centres, social interaction, and changes in lifestyle secondary to study participation.\n\nResearchers will collect information before and after the 26 weeks to see if creatine supplementation and\u002For resistance training have any effects on cognition, brain health, and\u002For physical function. The investigators suspect that both creatine supplementation and resistance training will improve cognition, brain health, and physical function alone. However, it is thought that the combination of creatine supplementation and resistance training will improve cognition, brain health, and physical function more.",[133,134,27],"Creatine","Exercise",[136,137,138,139,140,73,141,142],"older adults","physical activity","cognition","neuroimaging","mobility","creatine","dietary supplementation","2026-08-17",{"date":44,"type":47},{"date":146,"type":47},"2026-01-01",{"date":148,"type":21},"2027-12",{"name":150,"class":54},"Western University, Canada",{"id":152,"slug":153,"hasResults":12,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":4,"eligibilityCriteria":157,"healthyVolunteers":12,"sex":18,"minAge":158,"maxAge":4,"enrollmentInfo":159,"targetDuration":4,"studyType":98,"phases":161,"briefSummary":162,"conditions":163,"keywords":164,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":84},"100652246","hippocampal-temporal-interference-stimulation-for-memory-and-dual-task-postural-control-in-older-adults-with-mild-cognitive-impairment-100652246","NCT07771036","Hippocampal Temporal Interference Stimulation for Memory and Dual-Task Postural Control in Older Adults With Mild Cognitive Impairment","Effects and Underlying Mechanisms of Hippocampal-Targeted Temporal Interference Stimulation on Memory Function and Dual-Task Postural Control in Older Adults With Mild Cognitive Impairment","1. Aged 65 years or older;\n2. Presence of subjective memory complaints;\n3. Objective cognitive impairment: screened using the Montreal Cognitive Assessment-Bejingversion (MoCA-BJ). The MoCA-BJ total score is 30 points. For individuals with \\\u003C12 years ofeducation, 1 point is added to the raw total score (corrected total score capped at 30 points); acorrected total score \\\u003C26 points indicates risk of cognitive impairment;\n4. Clinical Dementia Rating (CDR) score of 0.5;\n5. Does not meet diagnostic criteria for dementia: Mini-Mental State Examination (MMSE) scores\\>18 for illiterate individuals, 221 for those with primary school education, and \\>25 for those withjunior high school education or above;6. Retains independent activities of daily living (ADL) and is capable of cooperating with allassessments and interventions.","65 Years",{"count":160,"type":21},21,[100],"This trial aims to investigate whether a single session of 40 Hz hippocampal temporal interference stimulation can improve memory function and dual-task postural control among older adults with mild cognitive impairment (MCI). The primary research questions to be addressed are as follows:\n\n* Can 40 Hz hippocampal temporal interference stimulation boost memory test performance in older adults with MCI?\n* Can 40 Hz hippocampal temporal interference stimulation improve walking and balance ability under dual-task conditions in older adults with MCI? Researchers will compare active 40 Hz hippocampal temporal interference stimulation against sham stimulation to identify whether this intervention yields positive immediate effects on memory function and dual-task postural control.\n\nParticipants will be required to:\n\n* Attend three laboratory visits over approximately three weeks, and receive one session of active stimulation and one session of sham stimulation in random order, with an interval of at least seven days between the two stimulation visits;\n* Complete memory and motor function assessments before and after each stimulation session;\n* Undergo functional magnetic resonance imaging (fMRI) scans to detect changes in brain activity.",[27],[165,166,167],"Mild Cognitive Impairment","Temporal Interference Stimulation","TIs","2026-08-13",{"date":170,"type":47},"2026-08-18",{"date":172,"type":47},"2026-07-30",{"date":174,"type":21},"2027-07-30",{"name":176,"class":54},"Shanghai University of Sport",{"id":178,"slug":179,"hasResults":12,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":4,"eligibilityCriteria":183,"healthyVolunteers":93,"sex":18,"minAge":184,"maxAge":4,"enrollmentInfo":185,"targetDuration":4,"studyType":98,"phases":187,"briefSummary":189,"conditions":190,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":192,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":84},"100651777","phase-3-a-clinical-study-evaluating-the-diagnostic-performance-and-safety-of-pet-for-the-deposition-of-a-plaques-in-the-brain-of-participants-with-normal-cognitive-function-mci-and-ad-using-18ffluorbetazine-injection-100651777","NCT07764679","A Clinical Study Evaluating the Diagnostic Performance and Safety of PET for the Deposition of Aβ Plaques in the Brain of Participants With Normal Cognitive Function, MCI and AD Using [18F]Fluorbetazine Injection","A Multicenter Phase III Clinical Study Evaluating the Diagnostic Performance and Safety of PET for the Deposition of Aβ Plaques in the Brain of Participants With Normal Cognitive Function, MCI and AD Using [18F]Fluorbetazine Injection","Inclusion Criteria:\n\n1 1. Men or women aged ≥ 40 years (including the threshold age). 2. Men or women with fertility must use effective contraceptive measures during the study period. Effective contraceptive measures include sterilization, intrauterine hormone devices, condoms, birth control pills, abstinence, or vasectomy.\n\n3\\. Meet the diagnostic criteria for normal cognitive function, Mild Cognitive Impairment (MCI), or Alzheimer's disease (AD).\n\n4\\. Participants voluntarily join the study, can cooperate with the experimental observations, and sign a written informed consent form. For participants with AD dementia, the informed consent form must be signed together with their legal guardian. If the participant is unable to sign the informed consent form due to limited cognitive ability or other reasons, the participant's signature space may be left blank, with the reason documented. The guardian should sign in the designated space for explanation.\n\nExclusion Criteria:\n\n1. Known allergy to \\[18F\\]Fluorbetazine injection or its excipients.\n2. Presence of previously implanted metal devices that are incompatible with MRI examinations, including pacemakers, defibrillators, insulin pumps, cochlear implants, intraocular metal implants, nerve stimulators, or CNS aneurysm clips; or suffering from claustrophobia or intolerance to imaging procedures for other reasons.\n3. Cognitive impairment caused by reasons other than Alzheimer's disease (AD).\n4. Cranial MRI scan shows one or more of the following results:\n\n   * More than 2 infarctions with a diameter greater than 2 cm in any part of the brain;\n   * Infarctions of any diameter in key areas such as the thalamus, hippocampus, entorhinal cortex, hippocampal gyrus, gyrus, cortex, or other subcortical gray matter nuclei;\n   * Fazekas Scale grading of white matter lesions \\> 2;\n   * Presence of brain tumors, intracranial infections, or cerebral hemorrhage, and deemed unsuitable for participation in this study by the researchers.\n5. Current clinically significant psychiatric illnesses, such as severe depression or schizophrenia, based on medical history, and the researchers have assessed that the imaging process cannot be completed. Researchers should carefully consider whether participants with dementia and behavioral disorders who may require psychiatric medication can complete the imaging process.\n6. Received radiopharmaceutical imaging or treatment within at least 5 half-lives prior to screening.\n7. Suffering from other serious and\u002For poorly controlled and\u002For unstable diseases, and deemed unsuitable for participation in this study by the researcher.\n8. Positive test results for human immunodeficiency virus (HIV) antibodies or Treponema pallidum antibodies.\n9. History of alcohol or drug abuse.\n10. Pregnant or lactating women with positive pregnancy test results during the screening period (including premenopausal women who have not undergone surgical sterilization and women within one year after menopause).\n11. Participated in any clinical trials within 4 weeks prior to enrollment and used investigational drugs; or those who plan to participate in any clinical trials during the study period.\n12. Other situations deemed unsuitable for participating in this clinical trial by the researchers.\n\nParticipants with Normal Cognitive Function\n\n1\\. Any evidence suggesting the possibility of AD from previous MRI, CT, or other biomarker studies.\n\nMCI and AD Dementia Participants\n\n1. Received anti-Aβ targeted therapy drugs, such as lecanemab monoclonal antibody, or treated or prophylactic anti-Aβ vaccines.\n2. Suffering from neurodegenerative diseases other than AD, including but not limited to Parkinson's disease, Pick's disease, frontotemporal degeneration (FTLD), Huntington's disease, Down syndrome, Creutzfeldt-Jakob disease, normal pressure hydrocephalus, or progressive supranuclear palsy (PSP).\n3. Previously or currently diagnosed with dementia other than AD, including but not limited to Parkinson's disease dementia, Lewy body dementia, frontotemporal dementia, vascular dementia, mixed dementia, etc.","40 Years",{"count":186,"type":21},400,[188],"PHASE3","A multicenter phase III clinical study evaluating the diagnostic performance and safety of PET for the deposition of Aβ plaques in the brain of participants with normal cognitive function, MCI and AD using \\[18F\\]Fluorbetazine injection.",[27,191],"Alzheimer's Disease (AD)",{"date":193,"type":47},"2026-08-14",{"date":195,"type":47},"2025-06-20",{"date":197,"type":21},"2028-12-31",{"name":199,"class":83},"HTA Co., Ltd.",{"id":201,"slug":202,"hasResults":12,"nctId":203,"briefTitle":204,"officialTitle":204,"acronym":4,"eligibilityCriteria":205,"healthyVolunteers":93,"sex":18,"minAge":206,"maxAge":207,"enrollmentInfo":208,"targetDuration":4,"studyType":98,"phases":210,"briefSummary":211,"conditions":212,"keywords":214,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":217,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":84},"100642131","use-of-a-mobile-brain-body-imaging-approach-to-evaluate-the-effects-of-rhythmic-auditory-stimulation-on-gait-and-brain-function-in-alzheimers-disease-100642131","NCT07659964","Use of a Mobile Brain-Body Imaging Approach to Evaluate the Effects of Rhythmic Auditory Stimulation on Gait and Brain Function in Alzheimer's Disease","Inclusion Criteria:\n\nGeneral Inclusion (both healthy and AD populations):\n\n* Community-dwelling\n* Capable of walking short community distances (approximately 10-15 minutes at a time) without assistance from another person or a device (such as a cane).\n* Able to communicate with researchers\n* Age 50-90 (inclusive)\n\nPopulation-specific Inclusion criteria:\n\n* Healthy -\n\n  * No diagnosis of AD\n* AD population-\n\nCERAD score of \\\u003C1.5 SD from age + education adjusted norms on delayed recall domain or one or more other cognitive domains (i.e. language, attention).\n\nMoCA score between 20-30 MMSE score between 25-30\n\nExclusion Criteria:\n\n* Presence of significant hearing impairment\n* Current orthopedic, neurologic or other medical condition that limits the ability to walk.\n\nThe MOCA, MMSE and CERAD tests will be completed in-person after the participant consents into the study. If the participant is determined to be ineligible based on their performance on these tests (compared to inclusion requirements listed above), they will be informed that they are not eligible for this study and the study visit will be cancelled. They will then be withdrawn from the study; their clinical tests and study documentation will be maintained for the purposes of completeness, but will not be used for any study analyses.","50 Years","90 Years",{"count":209,"type":21},40,[100],"Alzheimer's Disease (AD) is associated with impairments in both gait and cognition, significantly increasing fall risk. Falls are a leading cause of injury-related disability in older adults, and individuals with AD experience a nearly threefold higher rate of falls compared to neurotypical older adults. There is an urgent need for fall prevention interventions tailored to the unique deficits of individuals with AD. Converging evidence suggests that interventions aiming to reduce fall risk in AD should target both gait and cognition. Rhythmic music interventions, such as Rhythmic Auditory Stimulation (RAS) can harness global brain activation and auditory-motor entrainment to facilitate high-intensity exercise to alleviate AD-related neurocognitive and gait dysfunction. This study aims to assess the neural correlates of gait dysfunction in people with AD, evaluate if baseline neurocognitive impairment is predictive of the effects of RAS, and evaluate RAS benefits for individuals with AD.",[213,27],"Alzheimer Disease (AD)",[215],"RAS","2026-08-12",{"date":168,"type":47},{"date":219,"type":47},"2026-06-01",{"date":221,"type":21},"2026-12",{"name":223,"class":54},"Boston University Charles River Campus",{"id":225,"slug":226,"hasResults":12,"nctId":227,"briefTitle":228,"officialTitle":229,"acronym":4,"eligibilityCriteria":230,"healthyVolunteers":12,"sex":18,"minAge":158,"maxAge":231,"enrollmentInfo":232,"targetDuration":4,"studyType":98,"phases":234,"briefSummary":235,"conditions":236,"keywords":238,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":243,"lastUpdatePostDateStruct":244,"startDateStruct":245,"completionDateStruct":246,"leadSponsor":248,"locationsCount":4},"100651673","high-amplitude-functional-exercises-in-older-adults-with-mild-cognitive-impairment-100651673","NCT07762235","High-Amplitude Functional Exercises in Older Adults With Mild Cognitive Impairment","Effects of Dual-Task-Based High-Amplitude Functional Exercises on Balance and Functional Mobility in Older Adults With Mild Cognitive Impairment","Inclusion Criteria:\n\n* Living independently\u002Factively in a nursing home.\n* Diagnosis of Mild Cognitive Impairment (MCI) based on a standardized screening test, with a Montreal Cognitive Assessment (MoCA) score of 18-25.\n* Ability to walk independently for at least 10 meters without an assistive device or with only a cane\u002Fsingle-point support.\n* Sufficient vision and hearing capacity to follow dual-task instructions and exercise directions, which may be corrected with glasses or hearing aids.\n* Stable medical condition that does not prevent participation in the exercise program throughout the study.\n\nExclusion Criteria:\n\n* Diagnosis of dementia or severe cognitive impairment based on cognitive screening (MoCA \\\u003C17).\n* Neurological conditions that primarily affect balance, such as Parkinson's disease, residual effects of stroke, multiple sclerosis, or cerebellar ataxia.\n* Severe osteoarthritis, active inflammatory joint disease, or a history of major orthopedic surgery within the previous 6 months that could limit exercise performance.\n* Uncontrolled hypertension, heart failure (NYHA Class III-IV), or cardiopulmonary instability causing symptoms during exercise.\n* Advanced vestibular pathology or severe loss of proprioception in the lower extremities that could be the primary cause of balance impairment.","85 Years",{"count":233,"type":21},36,[100],"This study will investigate the effects of dual-task-based high-amplitude functional exercises on balance and functional mobility in older adults with mild cognitive impairment. A total of 36 participants aged 65 years and older will be randomly assigned to either a high-amplitude functional exercise group or a traditional balance and mobility exercise group. Both groups will participate in exercise sessions four times per week for four weeks, with each session lasting 60 minutes. The effects of the exercise programs will be evaluated by assessing balance, functional mobility, dual-task performance, walking performance, fear of falling, and independence in daily activities before and after the intervention.",[27,237],"Exercises",[165,69,239,240,241,242],"High-Amplitude Functional Exercises","Dual-Task Training","Functional Mobility","Dual-Task Cost","2026-08-09",{"date":168,"type":47},{"date":44,"type":21},{"date":247,"type":21},"2027-04-05",{"name":249,"class":54},"Istinye University",{"id":251,"slug":252,"hasResults":12,"nctId":253,"briefTitle":254,"officialTitle":255,"acronym":4,"eligibilityCriteria":256,"healthyVolunteers":12,"sex":18,"minAge":127,"maxAge":4,"enrollmentInfo":257,"targetDuration":4,"studyType":98,"phases":258,"briefSummary":259,"conditions":260,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":262,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":4},"100651118","medication-self-management-technology-for-older-adults-100651118","NCT07754994","Medication Self-Management Technology for Older Adults","Remote Hypertension Medication Self-Management Technology for Older Adults","Inclusion Criteria:\n\n* Age 60+\n* Fluent in English\n* Adequate visual and auditory acuity\n* Community dwelling\n* Lives alone\n* Self-reported memory problems\n* Manage at least one hypertension medication\n* Passing score on Telephone Interview for Cognitive Status - Modified (TICS- M) between 27-37\n* Passing score on Montreal Cognitive Assessment (MoCA) between 20 and 26\n* Geriatric Depression Scale (GDS) score of 6 or lower\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n\nExclusion Criteria:\n\n* Diagnosis of dementia\n* Major communication difficulties",{"count":209,"type":21},[100],"The goal of this feasibility study is to evaluate the preliminary impact of a mobile health application (app) called bpMedManage-R, designed to support hypertension medication self-management in persons with mild cognitive impairment (PwMCI) who live alone. The main questions this study aims to answer are whether the bpMedManage-R app shows preliminary impact on medication-related self-regulation (the ability to consistently take medications as prescribed) and self-efficacy (confidence in independently managing medication use). Participants will be randomized after a baseline assessment to the bpMedManage-R Immediate Group or the bpMedManage-R Delayed Group. Participants assigned to the Immediate Group will complete a 4-week baseline adherence period, at the end of which they will enter the intervention phase. A remote training session will be conducted to initiate the intervention phase, during which participants will download the app, learn to use it, and set up their medication schedule and reminders within the app with support from the study team. They will then use the app for 8 weeks to self-manage their medications, take part in brief weekly check-ins to review progress, and complete Outcome Assessment 1 at the end of the 8-week intervention phase. Participants assigned to the Delayed Group will complete a 12-week baseline adherence period, at the end of which they will complete Outcome Assessment 1. Subsequently, they will enter the intervention phase and will follow a process similar to that of the Immediate Group. At the end of the 8-week intervention phase, they will complete Outcome Assessment 2. Researchers will compare participants who receive the bpMedManage-R app intervention immediately to those assigned to the delayed control group.",[27],"2026-08-07",{"date":263,"type":47},"2026-08-10",{"date":265,"type":21},"2026-10",{"date":267,"type":21},"2028-06",{"name":269,"class":54},"University of Illinois at Urbana-Champaign",{"id":271,"slug":272,"hasResults":12,"nctId":273,"briefTitle":274,"officialTitle":274,"acronym":275,"eligibilityCriteria":276,"healthyVolunteers":93,"sex":18,"minAge":158,"maxAge":4,"enrollmentInfo":277,"targetDuration":4,"studyType":98,"phases":279,"briefSummary":280,"conditions":281,"keywords":282,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":285,"startDateStruct":286,"completionDateStruct":288,"leadSponsor":290,"locationsCount":84},"100610270","designing-a-spatial-navigation-intervention-protocol-informed-by-region-specific-brain-activation-for-mild-cognitive-impairment-100610270","NCT07225400","Designing a Spatial Navigation Intervention Protocol Informed by Region-specific Brain Activation for Mild Cognitive Impairment","SNav","Inclusion Criteria:\n\n* Age 65 and older with amnestic mild cognitive impairment (aMCI);\n* Can speak English;\n* Agrees to MoBI recording;\n* Normal or corrected-to-normal vision\u002Faudition;\n* Able to walk unassisted for 10 minutes;\n* Plan to be in the area for next year\n\nExclusion Criteria:\n\n* Dementia (Memory Impairment\u002FAD8 screen);\n* Medical conditions that affect participation such as vertigo and neck pain;\n* Hospitalization in the past six months or plans for surgery affecting participation in the next four months;\n* Mobility limitations solely due to musculoskeletal limitation or pain;\n* Terminal illness with life expectancy less than 12 months;\n* Presence of clinical disorders that overtly alter attention like delirium;\n* Active psychoses or psychiatric symptoms;\n* Living in nursing home;\n* Participation in intervention trial;\n* Standard contraindications to EEG including seizure medication, epilepsy, stroke, traumatic brain injury;\n* Pregnant women",{"count":278,"type":21},30,[100],"The goal of this one-arm clinical trial is to determine whether participants with mild cognitive impairment (MCI) can successfully navigate a virtual reality (VR) maze. The VR maze is designed as a training tool aimed at improving participants' spatial navigation abilities.\n\nMain Aims:\n\n1. To determine whether at least 70% of older adults enrolled in the study can complete twenty-four 50-minute training sessions over a 4-month period.\n2. To assess whether combining virtual reality with EEG recordings can be used to measure brain activation and changes in brain activation associated with spatial navigation learning.\n\nParticipants will:\n\n1. Walk in an open, unobstructed space while wearing VR goggles.\n2. Explore up to fifty different virtual mazes in sequence and attempt to find their way through each one.",[27],[283,284],"Spatial navigation training","Virtual reality maze design",{"date":263,"type":47},{"date":287,"type":21},"2026-10-01",{"date":289,"type":21},"2027-12-23",{"name":291,"class":54},"Albert Einstein College of Medicine",{"id":293,"slug":294,"hasResults":12,"nctId":295,"briefTitle":296,"officialTitle":297,"acronym":298,"eligibilityCriteria":299,"healthyVolunteers":12,"sex":18,"minAge":206,"maxAge":300,"enrollmentInfo":301,"targetDuration":4,"studyType":98,"phases":303,"briefSummary":305,"conditions":306,"keywords":307,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":311,"lastUpdatePostDateStruct":312,"startDateStruct":314,"completionDateStruct":316,"leadSponsor":318,"locationsCount":84},"100651158","phase-2-safety-assessment-of-h2-inhalation-in-patients-with-mild-cognitive-impairment-100651158","NCT07757542","Safety Assessment of H2 Inhalation in Patients With Mild Cognitive Impairment","Safety Assessment of Molecular Hydrogen Inhalation in Patients With Mild Cognitive Impairment","HYDRO-MCI","Inclusion Criteria:\n\n* patients diagnosed with mild cognitive impairment (MCI) with an overall good health condition\n* generally good health, with the ability to perform daily activities independently (modified Rankin score 0-2, Barthel index minimum 70 points)\n* age between 50 and 80 years, ensuring inclusion of individuals within the typical risk range for cognitive decline\n* a reliable study partner or caregiver who can provide accurate information about the participant's cognitive and functional abilities throughout the study\n* stable medical condition, without major fluctuations in health status that could interfere with cognitive assessments\n* signed informed consent, ensuring that participants understand the study protocol and potential risks\n\nExclusion Criteria:\n\n* pregnancy or lactation, as the safety of hydrogen inhalation therapy in these populations has not been established\n* use of medications or investigational treatments that could significantly affect cognitive function or interfere with study outcomes\n* history of severe psychiatric disorders such as major depression, bipolar disorder, or schizophrenia, which may independently influence cognitive performance\n* history of cerebrovascular events, including recent stroke or transient ischemic attack, which may confound cognitive outcomes\n* severe cardiovascular diseases, including uncontrolled hypertension, recent myocardial infarction, or heart failure, that could pose additional risks during the study\n* chronic kidney disease (stage 3 or higher), as impaired renal function may alter systemic metabolism and affect the study's findings\n* significant respiratory disorders, such as severe chronic obstructive pulmonary disease (COPD) or restrictive lung diseases, that could impact the safety of hydrogen inhalation\n* known hypersensitivity or allergic reactions to materials used in the hydrogen delivery system, such as nasal cannulas or facial masks\n* recent participation in another clinical trial within the past 90 days, to prevent potential interactions and ensure unbiased study results","80 Years",{"count":302,"type":21},34,[304],"PHASE2","An open-label, one-arm, single-center clinical study tested safety and efficacy of one hour daily dosage of H2 gas in a form of inhalation. Dosage is administered during morning hours every working day according to detailed instructions to study participants.\n\nPrimary objective: To verify the safety of hydrogen gas inhalation on a sample of patients with mild cognitive impairment (according to the objective opinion of the physician) and diagnosed mild to moderate form of dementia, as well as to verify cognitive abilities via tests from prof. MUDr. Aleš Bartoš, Ph.D. - ALBA (Amnesia Light and Brief Assessment) and POBAV (Naming of pictures and their equipment).\n\nSecondary objective: To assess the effect on specific health indicators (e.g. inflammation, antioxidant capacity, metabolism) by blood sampling as well as blood pressure\u002Fpulse measurement and BMI.\n\nPrimary endpoint: Inhalation Safety, Questionnaire - Subjective Assessment (ALBA and POBAV).\n\nSecondary endpoints: Biochemical indicators (e.g. inflammation, antioxidant status), blood analysis and BP\u002FPulse + BMI.\n\nStudy population: 50-80 years old participants with mild cognitive declin in overall good health condition.\n\nInclusion criteria:\n\n* patients diagnosed with mild cognitive impairment (MCI) with an overall good health condition\n* generally good health, with the ability to perform daily\n* activities independently (modified Rankin score 0-2, Barthel index minimum 70 points)\n* age between 50 and 80 years, ensuring inclusion of individuals within the typical risk range for cognitive decline\n* a reliable study partner or caregiver who can provide accurate information about the participant's cognitive and functional abilities throughout the study\n* stable medical condition, without major fluctuations in health status that could interfere with cognitive assessments\n* signed informed consent, ensuring that participants understand the study protocol and potential risks\n\nExclusion criteria:\n\n* pregnancy or lactation, as the safety of hydrogen inhalation therapy in these populations has not been established\n* use of medications or investigational treatments that could significantly affect cognitive function or interfere with study outcomes\n* history of severe psychiatric disorders such as major depression, bipolar disorder, or schizophrenia, which may independently influence cognitive performance\n* history of cerebrovascular events, including recent stroke or transient ischemic attack, which may confound cognitive outcomes\n* severe cardiovascular diseases, including uncontrolled hypertension, recent myocardial infarction, or heart failure, that could pose additional risks during the study\n* chronic kidney disease (stage 3 or higher), as impaired renal function may alter systemic metabolism and affect the study's findings\n* significant respiratory disorders, such as severe chronic obstructive pulmonary disease (COPD) or restrictive lung diseases, that could impact the safety of hydrogen inhalation\n* known hypersensitivity or allergic reactions to materials used in the hydrogen delivery system, such as nasal cannulas or facial masks\n* recent participation in another clinical trial within the past 90 days, to prevent potential interactions and ensure unbiased study results Duration of the study for each participant: 24 weeks (12 weeks of hydrogen inhalation + 12 weeks withou hydrogen inhalation) This pilot study is not designed for formal hypothesis testing; its purpose is to gather descriptive safety data and estimate effect sizes for future research. We will enroll 30 participants to gather enough information on safety, tolerability, and feasibility.\n\nThe primary analysis will concentrate on the frequency and severity of adverse events (AEs\u002FSAEs) and ALBA + POBAV scores to evaluate cognitive changes. Descriptive statistics will summarize adverse events, vital signs, and lab results.\n\nIn the secondary analysis, we will assess variations in biochemical markers (inflammation, antioxidant capacity, metabolism) and physiological metrics (blood pressure, pulse, BMI) using paired t-tests or Wilcoxon signed-rank tests, depending on how the data is distributed.\n\nAny missing safety data will be conservatively imputed, and multiple imputation techniques will be utilized for efficacy measurements. While there is no formal interim analysis planned, continuous safety monitoring will be carried out.\n\nResults will be shared through summary statistics, tables, and appropriate graphical representations, offering preliminary insights into the feasibility and potential advantages of molecular hydrogen inhalation therapy.",[27],[308,309,138,310],"hydrogen","inhalation","Mild cognitive impairment","2026-08-05",{"date":313,"type":47},"2026-08-11",{"date":315,"type":47},"2026-01-12",{"date":317,"type":21},"2027-10-31",{"name":319,"class":54},"University of Ostrava",{"id":321,"slug":322,"hasResults":12,"nctId":323,"briefTitle":324,"officialTitle":324,"acronym":325,"eligibilityCriteria":326,"healthyVolunteers":12,"sex":18,"minAge":327,"maxAge":4,"enrollmentInfo":328,"targetDuration":4,"studyType":98,"phases":330,"briefSummary":331,"conditions":332,"keywords":336,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":311,"lastUpdatePostDateStruct":346,"startDateStruct":347,"completionDateStruct":349,"leadSponsor":351,"locationsCount":353},"100649253","prevalence-of-mild-cognitive-impairment-and-dementia-in-patients-admitted-to-non-neurological-rehabilitation-wards-100649253","NCT07731334","Prevalence of Mild Cognitive Impairment and Dementia in Patients Admitted to Non-neurological Rehabilitation Wards","COGinREHAB","Inclusion Criteria:\n\n* Age ≥45 years\n* Hospitalization for at least 7-10 days for a non-neurological condition, in cardiac, pulmonary, or orthopedic intensive rehabilitation units, or intermediate care units\n* Adequate fluency in the Italian language\n* Provision of written informed consent\n\nExclusion Criteria:\n\n* Illiteracy\n* Severe, uncorrected visual impairment and\u002For hearing loss\n* Severe verbal communication deficit\n* Inability to remain seated for the duration of the assessment\n* Inability to use the dominant upper limb\n* Altered state of consciousness or alertness (e.g., delirium)\n* Severe scalp skin lesions or dermatitis precluding electrode application for neurophysiological recordings\n* Previous or current history of severe psychiatric disorders (e.g., psychotic disorders, bipolar disorder, severe major depressive disorder with psychotic symptoms, current suicidal risk, or other psychiatric conditions judged by the investigator to interfere with study participation, procedural compliance, or interpretation of results)\n* Previous history or current presence of clinically relevant neurological pathologies other than cognitive impairment (e.g., epilepsy, stroke, neurodegenerative diseases such as Parkinson's disease or multiple sclerosis, moderate-to-severe traumatic brain injury, brain tumors, central nervous system infections, or other neurological conditions that may influence cognitive, behavioral, or neurological functioning, or otherwise compromise the study objectives)","45 Years",{"count":329,"type":21},384,[100],"Cognitive impairment is common among older adults hospitalized for non-neurological conditions but often goes unrecognized, particularly in rehabilitation settings where clinical attention is mainly focused on physical recovery. The COGinREHAB study is a multicenter, prospective, longitudinal interventional study conducted at three rehabilitation centers of the Fondazione Don Carlo Gnocchi in Italy (Florence and Milan).\n\nThe study will enroll 384 patients aged 45 years or older who are hospitalized for at least 7-10 days in cardiac, pulmonary, or orthopedic intensive rehabilitation units, or in intermediate care units, for conditions unrelated to the nervous system.\n\nAt admission, all participants undergo a clinical and cognitive screening visit. Patients whose screening results suggest possible cognitive impairment then undergo a more extensive neuropsychological evaluation. In those with confirmed cognitive impairment, additional blood tests are performed to measure biomarkers of neurodegeneration (GFAP, neurofilament light chain, and phosphorylated tau-217), together with APOE genotyping and a non-contrast brain CT scan. In a subset of these patients, resting-state EEG, auditory event-related potentials, actigraphy, and overnight polysomnography are also performed. Patients with confirmed cognitive impairment are invited to a follow-up visit 12 months later to assess whether their cognitive profiles and biological markers have changed.\n\nThe main purpose of the study is to estimate how frequently cognitive impairment occurs among patients admitted to non-neurological rehabilitation units, including how often it was previously undiagnosed. The study will also describe the clinical, biological, and neurophysiological profile of these patients and examine how cognitive impairment evolves over one year.",[333,27,165,334,335],"MCI","Cognitive Deficit","Cognitive Decline",[165,337,338,339,32,340,341,342,343,344,345,109],"Cognitive Screening","Multimodal Assessment","Cognitive Trajectories","Non-Neurological Rehabilitation","Plasma Biomarkers","Neurodegeneration","Neurophysiological Measures","Longitudinal Study","APOE Genotype",{"date":263,"type":47},{"date":348,"type":47},"2026-01-20",{"date":350,"type":21},"2028-12",{"name":352,"class":54},"Fondazione Don Carlo Gnocchi ETS",3,{"id":355,"slug":356,"hasResults":12,"nctId":357,"briefTitle":358,"officialTitle":359,"acronym":360,"eligibilityCriteria":361,"healthyVolunteers":12,"sex":18,"minAge":63,"maxAge":300,"enrollmentInfo":362,"targetDuration":4,"studyType":98,"phases":364,"briefSummary":366,"conditions":367,"keywords":368,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":311,"lastUpdatePostDateStruct":372,"startDateStruct":373,"completionDateStruct":375,"leadSponsor":377,"locationsCount":84},"100639116","phase-1-safety-and-tolerability-of-gamma-glutamylcysteine-ggc-oral-supplementation-in-mci-patients-100639116","NCT07583251","Safety And Tolerability Of Gamma Glutamylcysteine (GGC) Oral Supplementation In MCI Patients","Study For Safety And Tolerability Of Gamma Glutamylcysteine (GGC) Oral Supplementation In MCI Patients","MCI-GSH","Inclusion Criteria:\n\n1. Memory complaints;\n2. MCI diagnosis\n3. MoCA score between 18-25\n4. Age 55 - 80 years old.\n5. Ability to read and write in English\n\nExclusion Criteria:\n\n1. Subjects with a history of cancer;\n2. Subjects with a history of schizophrenia, manic-depressive disorder\n3. Subjects on antioxidant therapy (ashwagandha, gingko biloba, N-acetylcysteine or glutathione)\n4. Subjects on illicit drug (cocaine, heroin, marijuana, or fentanyl) abuse\u002Fdependence;",{"count":363,"type":21},9,[365],"PHASE1","The goal of this study is to evaluate the safety and tolerability of Gamma Glutamylcysteine (GGC) supplement at different doses (400mg\u002Fday or 800mg\u002Fday or 1200mg\u002Fday) when administered orally to patients with MCI over 3 months. This study is designed to generate preliminary clinical safety data to inform the feasibility and design of larger controlled trials.",[27],[369,370,333,371],"GSH","GGC","cognitive",{"date":261,"type":47},{"date":374,"type":47},"2026-08-04",{"date":376,"type":21},"2027-02",{"name":378,"class":54},"Pravat Mandal",{"id":380,"slug":381,"hasResults":12,"nctId":382,"briefTitle":383,"officialTitle":384,"acronym":4,"eligibilityCriteria":385,"healthyVolunteers":12,"sex":18,"minAge":206,"maxAge":231,"enrollmentInfo":386,"targetDuration":4,"studyType":98,"phases":388,"briefSummary":389,"conditions":390,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":391,"lastUpdatePostDateStruct":392,"startDateStruct":394,"completionDateStruct":396,"leadSponsor":398,"locationsCount":4},"100640309","phase-2-to-evaluate-the-safety-and-efficacy-of-rp902-tablets-100640309","NCT07579884","To Evaluate the Safety and Efficacy of RP902 Tablets","A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Safety and Efficacy of RP902 Tablets in the Treatment of Mild Cognitive Impairment Due to Alzheimer's Disease","Inclusion Criteria:\n\n* Voluntary participation and signed informed consent form.\n* Junior high school graduation or above, capable of completing cognitive function assessments and other tests specified in the protocol.\n* Meet the core clinical diagnostic criteria for mild cognitive impairment (MCI) of the National Institute on Aging-Alzheimer's Association (NIA-AA) (2024).\n* Mini-Mental State Examination (MMSE) score ≥ 24; Clinical Dementia Rating-Global Score (CDR-GS) = 0.5, with memory score ≥ 0.5.\n* 17-item Hamilton Depression Rating Scale (HAMD) total score ≤ 10.\n* Hachinski Ischemic Score (HIS) total score ≤ 4.\n\nExclusion Criteria:\n\n* Dementia caused by other etiologies.\n* Neurological diseases other than Alzheimer's Disease (AD).\n* Positive hepatitis B surface antigen (HBsAg) and\u002For hepatitis B core antibody (HBcAb) with positive HBV-DNA copy number (above upper limit of normal range); positive hepatitis C virus antibody (HCV Ab) with positive HCV RNA; positive human immunodeficiency virus antibody (HIV Ab); positive Treponema pallidum antibody (TP Ab).\n* Active systemic bacterial, viral, fungal or parasitic infection, or other clinically significant active infections deemed unsuitable by the investigator.\n* Male: QTcF \\> 450 ms; Female: QTcF \\> 470 ms, or other clinically significant abnormal electrocardiogram deemed unsuitable.\n* Severe or poorly controlled cardiovascular, respiratory, digestive, urinary, hematological, endocrine, or neurological diseases (except AD) within 6 months prior to screening visit.\n* History of active peptic ulcer, inflammatory bowel disease, or other severe gastrointestinal diseases affecting drug absorption within 6 months prior to screening visit; or history of gastrointestinal bleeding, perforation or gastrointestinal surgery within 5 years (excluding appendectomy, polypectomy, hemorrhoid surgery).\n* Malignant tumor diagnosed within 3 years prior to screening (excluding cured basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and radically resected carcinoma in situ).\n* Participation in other clinical trials within 3 months prior to randomization; subjects in non-interventional observational studies may be included if judged by the investigator to have no interference with the safety and efficacy of the study drug.\n* History of alcohol abuse or drug abuse within 1 year prior to screening visit.\n* History of severe drug allergy or multiple drug allergies.\n* Lactating women.\n* Other conditions deemed unsuitable for the study by the investigator.\n* Trial Groups",{"count":387,"type":21},360,[304],"The purpose of the study is to evaluate the preliminary efficacy of RP902 Tablets in participants with Alzheimer's disease (AD)-derived mild cognitive impairment (MCI) and provide a design basis for the Phase III study. This Phase II study plans to enroll 360 participants and will be conducted at approximately 50 sites in China. The study consists of a Screening Period (up to 4 weeks) and a double-blind treatment period (48 weeks). After completing the 48-week double-blind treatment period, participants may choose to continue into an extension treatment period (96 weeks) or undergo safety follow-up (4 weeks after the last dose).",[27],"2026-07-31",{"date":393,"type":47},"2026-08-03",{"date":395,"type":21},"2026-07",{"date":397,"type":21},"2031-05",{"name":399,"class":83},"Risen (Suzhou) Pharma Tech Co., Ltd.",{"id":401,"slug":402,"hasResults":12,"nctId":403,"briefTitle":404,"officialTitle":405,"acronym":406,"eligibilityCriteria":407,"healthyVolunteers":12,"sex":18,"minAge":206,"maxAge":408,"enrollmentInfo":409,"targetDuration":4,"studyType":98,"phases":411,"briefSummary":412,"conditions":413,"keywords":414,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":418,"lastUpdatePostDateStruct":419,"startDateStruct":420,"completionDateStruct":422,"leadSponsor":424,"locationsCount":84},"100650086","assessing-treatment-with-high-phenolic-evoo-supplements-for-neurovascular-activity-100650086","NCT07741773","Assessing Treatment With High-phenolic EVOO Supplements for Neurovascular Activity","Dietary Supplementation With EVOO Phenolics Prevents MCI Progression to Alzheimer's Disease","ATHENA","Inclusion Criteria:\n\n* CDR (Clinical Dementia Rating) score of 0.5 OR MoCA (Montreal Cognitive Assessment) score of 18-25.\n\nExclusion Criteria:\n\n* History or presence of vascular disease that may affect cognitive function\n* History or presence of stroke within the past 1 year\n* Recent transient ischemic attack (TIA) within the past 180 days\n* History of severe, clinically significant CNS trauma\n* History of intracranial tumor\n* History or presence of kidney disease (eGFR \\\u003C60 mL\u002Fmin\u002F1.73m2)\n* Presence of a pacemaker\n* Presence of metal in the body\n* Allergic to the MRI contrast agent \"Multihance\"\n* Pregnancy","70 Years",{"count":410,"type":21},20,[100],"The goal of this clinical trial is to determine whether the extra-virgin olive oil (EVOO) phenolic dietary supplement can improve memory function and modulate biomarkers among individuals with mild cognitive impairment (MCI). The main questions it aims to answer are:\n\n* Does dietary supplementation with EVOO phenolics improve cognitive function?\n* What would be the effect of the EVOO dietary supplement on other MCI-related biomarkers, including vascular function and biological pathways?\n\nResearchers will compare the EVOO dietary supplements with a placebo (a look-alike substance that contains no EVOO phenolics)\n\nParticipants will:\n\n* Take EVOO dietary supplements or a placebo daily for 6 months\n* Visit the study site during the 6-month study for screening and testing.",[27],[415,416,417,333],"Olive oil","Cognitive function","Cerebrovascular function","2026-07-27",{"date":393,"type":47},{"date":421,"type":21},"2026-09-01",{"date":423,"type":21},"2028-08-31",{"name":425,"class":54},"Augusta University",{"id":427,"slug":428,"hasResults":12,"nctId":429,"briefTitle":430,"officialTitle":430,"acronym":431,"eligibilityCriteria":432,"healthyVolunteers":12,"sex":18,"minAge":63,"maxAge":433,"enrollmentInfo":434,"targetDuration":4,"studyType":98,"phases":436,"briefSummary":437,"conditions":438,"keywords":440,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":418,"lastUpdatePostDateStruct":443,"startDateStruct":445,"completionDateStruct":447,"leadSponsor":449,"locationsCount":451},"100562343","phase-2-cognitive-training-and-neuroplasticity-in-mild-cognitive-impairment-cogit-2-trial-100562343","NCT06601933","Cognitive Training and Neuroplasticity in Mild Cognitive Impairment: COGIT-2 Trial","COGIT-2","Inclusion Criteria:\n\n1. Access to a home desktop or laptop computer or tablet at acceptable internet speed for the study duration.\n2. Participants need to be 55 to 89 years of age (inclusive) at the time of informed consent.\n3. Females need to be post-menopausal (last period more than 12 months earlier by history).\n4. Subjective cognitive complaints, i.e., memory or other cognitive complaints, e.g., naming\u002Flanguage.\n5. Meets criteria for cognitive impairment (CI), including either EMCI (early MCI) or LMCI (late MCI), defined as memory impairment documented by scoring below the education adjusted cutoff on the Logical Memory II subscale (Story A, Delayed Paragraph Recall) from the Wechsler Memory Scale - III (WMS-III) (the maximum score is 25). The criteria for MCI (includes EMCI and LMCI) and used in COGIT-2 are as follows: EMCI is defined by a WMS-III Logical memory delayed recall score of 3-6 with 0-7 years of education, score of 5-9 with 8-15 years of education, and score of 9-11 with 16 or more years of education. LMCI is defined by a WMS-III Logical Memory delayed recall score ≤ 2 with 0-7 years of education, score ≤ 4 with 8-15 years of education, and score ≤ 8 with ≥ 16 years of education.\n6. Montreal Cognitive Assessment (MoCA) score ≥ 20\u002F30.\n7. An informant (relative, friend, other caregiver) who contacts the participant at least weekly is required to provide information about the participant's functioning. This can be a telephone informant in the case of participants who do not have a live-in informant or close significant other. If the informant drops out, an alternate informant can be designated by the participant but the new informant will need to sign the informant information sheet.\n8. Must be English-speaking: Wide Range Achievement Test (WRAT3) score must indicate at least a 6th grade reading level with a score of ≥ 37.\n\nExclusion Criteria:\n\n1. Diagnosis of dementia of any type.\n2. Current clinical diagnosis of schizophrenia, schizoaffective disorder, psychosis, or bipolar I disorder (Diagnostic and Statistical Manual of Mental Disorders (DSM-5 TR) criteria).\n3. Current unstable or untreated major depression, or active suicidality based on a Suicide Severity Rating Scale (C-SSRS Screen version: positive answer to question 1 or 2 followed by item 6 positive answer leads to exclusion. Negative answer to questions 1 and 2: interview ends and the participant is not excluded for active suicidality).\n4. Current or recent (past 6 months) alcohol or substance use disorder (DSM-5 TR criteria).\n5. Clinical stroke with residual neurological deficits. While we will not exclude participants with cerebrovascular disease or transient ischemic attacks (TIAs), we do not wish to include participants with a frank clinical stroke because it is not clear that this type of participant is similar to the MCI participant generally, and clear-cut neurological impairment, e.g., hemiplegia\u002Fhemiparesis or speech impairment, may compromise the ability to do the procedures and to complete the neuropsychological test battery.\n6. Use of medications known to have a negative impact on cognition: benzodiazepines in lorazepam equivalents greater than or equal to 1 mg daily, narcotics, anticholinergic medications at ACB Calculator level 3), large number of sedating medications in combination. Current use of lecanemab or donanemab will be exclusionary.\n7. Presence of any of the following disorders: a) Central Nervous System Infections, with cerebrospinal fluid evidence of meningitis, encephalitis, or other infectious process; b) dementia of any type; c) Huntington's disease; d) Multiple sclerosis; e) Parkinson's disease; f) Other neurologic disorders with focal signs, e.g., amyotrophic lateral sclerosis.\n8. Acute, severe unstable medical illness in the judgment of the clinician. For cancer, acutely ill participants (including those with metastases) are excluded, but history of successfully treated cancer does not result in exclusion.\n9. Contraindication to MRI scan: MRI incompatible pacemakers and metal implants, any other contraindication to MRI. For participants with possible claustrophobia, they must be willing to do the MRI with adjunct lorazepam 0.5 mg to reduce anxiety. For participants who are recruited and are eligible for MRI but are unable to complete the baseline MRI, a repeat MRI for the same time-point can be attempted if the subject is willing. Baseline MRI is required for study inclusion.\n10. Regular use of crosswords or formal computerized cognitive training platforms averaging once per week or more than once per week in the past year. Eligible participants who join the trial are instructed not to do these procedures on their own during the trial, i.e., independent of the study.\n11. Participation concurrently in another therapeutic clinical trial of a cognitive enhancing drug or device or procedure.\n12. Geriatric Depression Scale (Short Form) score of ≥ 6.","89 Years",{"count":435,"type":21},240,[304],"Effective, clinically meaningful treatments are lacking for patients with mild cognitive impairment (MCI), which is associated with increased risk of transition to dementia. Cognitive training represents an important therapeutic strategy. In a previous study, crossword puzzles were found to be superior to computerized cognitive training on the primary cognitive outcome and function with decreased brain atrophy. Building on these findings, this study will evaluate and compare the impact of high dose crosswords (4 puzzles per week) to low dose crosswords (1 puzzle per week) and a health education control group on the cognition and function of participants.",[27,439],"Cognitive Training",[165,439,441,442],"Crossword Puzzles","Health Education",{"date":444,"type":47},"2026-07-28",{"date":446,"type":47},"2024-12-17",{"date":448,"type":21},"2030-08-31",{"name":450,"class":54},"Columbia University",4,{"id":453,"slug":454,"hasResults":12,"nctId":455,"briefTitle":456,"officialTitle":457,"acronym":4,"eligibilityCriteria":458,"healthyVolunteers":93,"sex":18,"minAge":127,"maxAge":4,"enrollmentInfo":459,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":460,"conditions":461,"keywords":464,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":483,"lastUpdatePostDateStruct":484,"startDateStruct":486,"completionDateStruct":488,"leadSponsor":490,"locationsCount":4},"100649349","cmind-ai-web-tool-usability-study-hong-kong-100649349","NCT07735013","cMIND AI Web Tool Usability Study (Hong Kong)","Development and Validation of a Web-Based AI System for Assessing the Cantonese-Style Mediterranean Diet (cMIND) Index","Inclusion Criteria:\n\n* Aged 60 years or above\n* Community-dwelling in Hong Kong\n* Able to provide informed consent\n* Basic ability to use a smartphone or tablet (with assistance if needed)\n* Consuming Cantonese-style meals as the primary dietary pattern for ≥ 5 days per week for the past 3 months or longer)\n\nExclusion Criteria:\n\n* Severe visual or motor impairment that prevents taking meal photos even with assistance\n* Self-reported diagnosis of dementia or Alzheimer's disease, or other psychiatric\u002Fmedical conditions that would interfere with participation or valid outcome assessment\n* Current participation in other interventional nutrition or technology studies",{"count":410,"type":21},"This study is testing a new web-based tool that uses artificial intelligence (AI) to help older adults in Hong Kong check how healthy their Cantonese-style meals are for brain health. The tool is based on the cMIND diet, a Chinese-adapted version of a known healthy eating pattern that may support memory and thinking skills.\n\nParticipants will use the web app to take photos of their usual meals for at least 10 days over two weeks. The AI will automatically identify ingredients and give a score showing how well the meal follows the cMIND diet. The study will also ask participants to complete a short questionnaire and a brief interview to find out how easy and useful the tool is for older adults.\n\nThe purpose of this small study is to see whether the AI tool is user-friendly and acceptable for older people. Results will help improve the tool for future use to support healthy ageing and brain health.",[27,462,463],"Healthy Aging","Nutrition",[465,466,467,468,469,470,471,136,472,73,473,474,475,476,477,478,479,480,481,482],"cMIND diet","Cantonese Mediterranean diet","AI dietary assessment","web-based AI tool","meal photo analysis","Cantonese mixed dishes","usability testing","congitive health","healthy ageing","gerontechnology","nutrition monitoring","dietary adherence","AI food recognition","Cantonese cuisine","brain health diet","feasibility study","acceptability study","Hong Kong older adults","2026-07-24",{"date":485,"type":47},"2026-07-29",{"date":487,"type":21},"2027-09",{"date":489,"type":21},"2028-02",{"name":491,"class":54},"Hong Kong Metropolitan University",{"id":493,"slug":494,"hasResults":12,"nctId":495,"briefTitle":496,"officialTitle":497,"acronym":498,"eligibilityCriteria":499,"healthyVolunteers":12,"sex":18,"minAge":500,"maxAge":4,"enrollmentInfo":501,"targetDuration":4,"studyType":98,"phases":502,"briefSummary":503,"conditions":504,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":505,"lastUpdatePostDateStruct":506,"startDateStruct":507,"completionDateStruct":509,"leadSponsor":511,"locationsCount":513},"100649155","digital-solutions-for-predicting-the-biological-mechanisms-of-alzheimers-disease-through-the-analysis-of-risk-factors-100649155","NCT07731191","Digital Solutions for Predicting the Biological Mechanisms of Alzheimer's Disease Through the Analysis of Risk Factors","Development of Digital Solutions for the Prediction of the Biological Mechanisms of Alzheimer's Disease Through the Analysis of Risk Factors (PrevAI)","PrevAl","Inclusion Criteria:\n\n* Male or female subjects aged more than 18 years at the time of signing the informed consent form;\n* Subjects with MCI or SCD who, at the time of their first visit, did not have a clinical diagnosis of dementia (MMSE ≥ 24);\n* Smartphone user.\n\nExclusion Criteria:\n\n* Age younger than that stated in the inclusion criterion;\n* Inability to understand.","18 Years",{"count":435,"type":21},[100],"Population ageing is one of the main factors responsible for the global increase in the prevalence of dementia. Recent evidence suggests that modifiable risk factors, such as cardiovascular disease and lifestyle, may increase the risk of developing dementia and contribute to its progression. Furthermore, the use of non-invasive plasma biomarkers enables the identification of individuals with neurodegenerative diseases, even in the prodromal stage. However, the relationship between the cumulative burden of risk factors and plasma biomarkers is still poorly understood.\n\nThe main objective of this study is to identify and estimate the risk associated with modifiable and non-modifiable predictors (risk factors) linked to the development of Alzheimer's disease (AD) and non-AD dementia, as well as biological alterations consistent with AD or non-AD, through the development of a predictive tool based on Artificial Intelligence algorithms (Machine Learning model). The study also aims to provide a range of technological tools (an app for active patient monitoring and a web platform for clinicians) that could improve risk stratification and the personalisation of care pathways.\n\nThe study is divided into two different phases. Firstly, a retrospective phase is conducted in order to construct a predictive model for the risk of dementia and biological alterations consistent with AD. Secondly, a prospective phase is performed for the validation of the predictive model.",[27,28],"2026-07-23",{"date":444,"type":47},{"date":508,"type":47},"2026-06-24",{"date":510,"type":21},"2026-11-15",{"name":512,"class":54},"IRCCS Centro San Giovanni di Dio Fatebenefratelli",2,{"id":515,"slug":516,"hasResults":12,"nctId":517,"briefTitle":518,"officialTitle":519,"acronym":4,"eligibilityCriteria":520,"healthyVolunteers":93,"sex":18,"minAge":500,"maxAge":207,"enrollmentInfo":521,"targetDuration":4,"studyType":98,"phases":522,"briefSummary":523,"conditions":524,"keywords":525,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":505,"lastUpdatePostDateStruct":530,"startDateStruct":531,"completionDateStruct":533,"leadSponsor":535,"locationsCount":513},"100626860","enhancing-attention-in-elderly-using-a-brain-computer-interface-100626860","NCT07441122","Enhancing Attention in Elderly Using a Brain-Computer-Interface","Building Cognitive Reserve Through Brain-Computer-Interfaces","Inclusion Criteria:\n\nYounger adults:\n\n* Good general health.\n* Normal or corrected vision.\n* no history of neurological\u002Fpsychiatric disease\n* ability to read and understand English\n* ability to understand information and ability to give a free and informed consent\n\nOlder adults:\n\n* Normal or corrected vision.\n* Self-reports no current diagnosis of dementia.\n* Ability to provide written\u002Felectronic, informed consent.\n\nExclusion Criteria:\n\nYounger Adults:\n\n* Neurological or psychiatric diseases that could be contraindicated for tACS (e.g., personal history of epilepsy\u002Fseizure brain damage, history of fainting, bipolar disorder, schizophrenia, current substance use disorder, etc.).\n* Medications that elevate seizure threshold (e.g., stimulant medication, high dose bupropion).\n* Factors hindering EEG acquisition and tACS delivery (e.g., skin infection, wounds, dermatitis, inability to access the scalp of the participant).\n\nOlder Adults:\n\n* Neurological or psychiatric diseases that could be contraindicated for tACS (e.g., personal history of epilepsy\u002Fseizure brain damage, pacemakers, history of fainting, bipolar disorder, schizophrenia, current substance use disorder, etc.).\n* Medications that elevate seizure threshold (e.g., stimulant medication, high dose bupropion).\n* Factors hindering EEG acquisition and tACS delivery (e.g., skin infection, wounds, dermatitis, inability to access the scalp of the participant).\n* Diagnosis of dementia.\n* Do not have the capacity to provide informed consent.",{"count":65,"type":21},[100],"Cognitive reserve refers to the brain's ability to maintain cognitive performance despite age-related changes or neuropathology. Enhancing cognitive reserve is thought to delay cognitive decline and improve functional outcomes in aging and neurodegenerative conditions. Attention and memory-related neural processes are considered key contributors to cognitive reserve, yet it remains unclear whether these neural markers can be deliberately strengthened through targeted training and non-invasive interventions.\n\nThe goal of this clinical study is to investigate whether mindfulness-based meditation and non-invasive brain stimulation can enhance neural markers of attention and memory that serve as proxies for cognitive reserve in cognitively healthy adults and older adults diagnosed with mild cognitive impairment (MCI). Investigators hypothesize that strengthening these neural markers will lead to measurable improvements in cognitive reserve-related functions in both healthy aging and MCI populations.\n\nThis study further hypothesizes that neural markers of attention can be selectively enhanced using an electroencephalography (EEG)-based brain-computer interface (BCI) combined with non-invasive interventions such as mindfulness-based relaxation or neuromodulation. During the study, participants will perform a computerized memory task while their EEG signals are recorded in real time. A BCI will analyze these signals to decode the presence or absence of the P300 event-related potential, a well-established neural marker of attentional control and cognitive resource allocation. Real-time feedback and intervention will be used to modulate these neural processes with the goal of promoting adaptive changes in attention-related brain activity.\n\nBy integrating EEG-based decoding, behavioral training, and non-invasive interventions, this study aims to determine whether targeted modulation of attention-related neural activity can support cognitive reserve in aging and mild cognitive impairment.",[27],[333,526,335,69,527,528,529],"Memory","Memory Impairment","Cognitive Control","Attention",{"date":418,"type":47},{"date":532,"type":47},"2026-07-01",{"date":534,"type":21},"2029-02-01",{"name":536,"class":54},"University of Texas at Austin",{"id":538,"slug":539,"hasResults":12,"nctId":540,"briefTitle":541,"officialTitle":542,"acronym":543,"eligibilityCriteria":544,"healthyVolunteers":12,"sex":18,"minAge":158,"maxAge":231,"enrollmentInfo":545,"targetDuration":4,"studyType":98,"phases":546,"briefSummary":547,"conditions":548,"keywords":549,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":553,"lastUpdatePostDateStruct":554,"startDateStruct":556,"completionDateStruct":558,"leadSponsor":560,"locationsCount":513},"100567639","effect-of-a-probiotic-formula-in-mild-cognitive-impairement-100567639","NCT06670807","Effect of a Probiotic Formula in Mild Cognitive Impairement","Clinical Trial to Evaluate the Efficacy of a Probiotic Formula on Cognitive Function in Mild Cognitive Impairement Patients.","PROBIOMIND","Inclusion Criteria:\n\n* Men and women aged between 60 and 85 years.\n* Present \"Mild Cognitive Impairment\" (MCI) based on:\n* MoCA test (\\\u003C 26 points) or score adjusted for educational level\n* and CDR test (≤ 0.5 points)\n* Maintain functional capacity according to the (I)ADL test (≥ 70 points)\n* Show \"cognitive concern\" reported by the participant and\u002For a surrogate caregiver\n* Demonstrate longitudinal decline in cognitive function (progressive and not stabilized) for more than 3-5 years.\n* BMI ≥ 20 and \\\u003C 30 kg\u002Fm²\n* Absence of a family or social environment that prevents treatment adherence.\n* Adequate cultural level and understanding of the clinical study.\n* Agree to participate voluntarily in the study and provide written informed consent.\n\nExclusion Criteria:\n\n* Subjects with severe neurological or psychiatric disorders due to any of the following causes: severe dementia, depression, epilepsy, schizophrenia, or bipolar disorder.\n* Subjects who have suffered a severe stroke prior to the study (FAZKAS=3)\n* Subjects with a history of malignancy \\\u003C 5 years (\\\u003C 5 years if the brain was affected)\n* Subjects who have experienced severe traumatic brain injury with structural brain injury and\u002For prior brain surgery\n* Subjects with pacemakers and those with metal implants that may interfere with EEG or MRI\n* Subjects treated with medications: benzodiazepines, neuroleptics, narcotics, anticonvulsants, or sedative-hypnotics in the last 3 months\n* Subjects who have been treated with antibiotics or probiotic supplements at least 3 months before the start of the study.\n* Subjects with hearing or visual impairments that prevent the evaluations included in the study\n* Subjects with severe illnesses affecting nutritional status (liver, kidney, etc.)\n* Subjects who have engaged in weight loss diets or significant dietary changes in the 8 weeks prior to starting the study\n* Subjects with high alcohol consumption (\\> 3 alcoholic beverages per day)",{"count":65,"type":21},[100],"Mild cognitive impairment is currently one of the most relevant social challenges, as its prevalence is expected to increase and it is associated with a higher risk of developing Alzheimer's disease or other types of dementia. Therefore, it is necessary to seek strategies that can be applied in the early stages to delay or reverse the progression of the disease.\n\nIn this context, probiotics have emerged as a promising alternative for managing cognitive disorders. This project is a clinical-nutritional trial to evaluate the utility of consuming a dietary supplement containing probiotics on the cognitive function of individuals with mild cognitive impairment. The study will involve 100 participants, selected from the Geriatrics Unit of San Carlos Clinical Hospital, as well as through various Leisure Centers in Madrid, randomly assigned to two groups of 50 individuals each (Experimental Group and Control Group). Participants assigned to the experimental group will consume the dietary supplement, while those in the control group will receive a placebo, which is a product without probiotics. Both groups will take 1 capsule per day of the assigned product at breakfast for 16 weeks. During this time, changes will be analyzed in various imaging tests, cognitive tests, and some blood parameters related to cognitive function. Changes in gut microbiota and different lifestyle factors (diet, body composition, physical activity, sleep) will also be evaluated.",[27],[27,550,416,551,463,552],"Probiotic","Microbiota","Elderly","2026-07-14",{"date":555,"type":47},"2026-07-16",{"date":557,"type":47},"2026-03-21",{"date":559,"type":21},"2027-06",{"name":561,"class":54},"Universidad Complutense de Madrid",{"id":563,"slug":564,"hasResults":12,"nctId":565,"briefTitle":566,"officialTitle":567,"acronym":568,"eligibilityCriteria":569,"healthyVolunteers":12,"sex":18,"minAge":570,"maxAge":4,"enrollmentInfo":571,"targetDuration":4,"studyType":98,"phases":573,"briefSummary":574,"conditions":575,"keywords":577,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":581,"lastUpdatePostDateStruct":582,"startDateStruct":583,"completionDateStruct":584,"leadSponsor":586,"locationsCount":84},"100645733","ai-conect-a-conversational-ai-for-early-dementia-prevention-in-socially-isolated-older-adults-100645733","NCT07701668","AI-CONECT: A Conversational AI for Early Dementia Prevention in Socially-Isolated Older Adults","AI-CONECT: A Conversational AI for Early Dementia Prevention in Socially-Isolated Older Adults Based on the Efficacy-Proven I-CONECT Study","AI-CONECT","Inclusion Criteria:\n\n* Aged 75+\n* Clinical diagnosis of MCI, or MMSE ≥ 24 or MoCA ≥ 18 (i.e., early MCI)\n* Identified as socially isolated by at least one of the two criteria: (1)score ≤ 12 on the 6-item Lubben Social Network Scale (LSNS-6); (2) engages in conversations lasting 30 minutes or longer, no more than twice per week, per subject self-report\n* GDS-15 (15-item Geriatric Depression Scale) at\u002Fbelow 9 (not severely depressed).\n* Social self-efficacy mean ≤ 8 (on the 0-10 scale) across the 6-item Social Self-Efficacy Scale at screening, indicating low confidence in social interaction.\n* Ability to understand the research consent form.\n* Ability to connect a tablet to the Internet.\n\nExclusion Criteria:\n\n* Diagnosed with dementia such as AD, ischemic vascular dementia, normal pressure hydrocephalus, or Parkinson's disease.\n* Schizophrenia, or other major psychiatric disorder defined by DSM-IV criteria.\n* Medications: Frequent use of high doses of analgesics; Use of sedative medications except for those used occasionally for sleep (≤2 per week); Use of unstable dosing of Cholinesterase inhibitors (need to be stable dosing for 2 months).","75 Years",{"count":572,"type":21},80,[100],"This randomized controlled trial examines the mechanisms of conversational AI-based interventions for early dementia prevention in socially isolated older adults.",[27,576],"Social Isolation",[576,578,579,580,27],"Artificial Intelligence","AI-Chatbot","I-CONECT","2026-07-13",{"date":553,"type":47},{"date":172,"type":21},{"date":585,"type":21},"2028-03-31",{"name":587,"class":54},"Massachusetts General Hospital",{"id":589,"slug":590,"hasResults":12,"nctId":591,"briefTitle":592,"officialTitle":593,"acronym":594,"eligibilityCriteria":595,"healthyVolunteers":12,"sex":18,"minAge":127,"maxAge":4,"enrollmentInfo":596,"targetDuration":4,"studyType":98,"phases":598,"briefSummary":599,"conditions":600,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":601,"lastUpdatePostDateStruct":602,"startDateStruct":603,"completionDateStruct":604,"leadSponsor":606,"locationsCount":4},"100645428","non-pharmacological-interventions-for-people-with-mild-cognitive-impairment-in-the-community-100645428","NCT07703267","Non-pharmacological Interventions for People With Mild Cognitive Impairment in the Community","Development of a 'Community-Family Mutual Support' Intervention Model for Patients With Mild Cognitive Impairment Based on Social Support Theory","CNPI-MCI","Inclusion Criteria:\n\n* Aged 60 years or older.\n* Meets the diagnostic criteria for mild cognitive impairment, including subjective cognitive decline, objective impairment in at least one cognitive domain, relatively preserved activities of daily living, and no diagnosis of dementia.\n* Has lived in the study community for at least 6 months.\n* Has completed primary school or above and is able to read and write.\n* Is able to communicate and complete the study assessments and intervention activities.\n* Voluntarily participates and provides written informed consent.\n\nExclusion Criteria:\n\n* Unable to communicate effectively.\n* Has severe visual or hearing impairment that prevents participation.\n* Has dementia, schizophrenia, or another severe psychiatric disorder.\n* Has a serious or unstable physical illness that prevents participation in the intervention.\n* Is currently participating in another cognitive training or similar intervention study.",{"count":597,"type":21},70,[100],"Mild cognitive impairment (MCI) may increase the risk of dementia. This study will evaluate an 8-week community-family mutual support intervention for adults aged 60 years or older with MCI. Participants will be randomly assigned to an intervention group or a control group. The control group will receive routine community care, while the intervention group will additionally receive cognitive training, health education, family support, mutual support activities, and individualized feedback. Cognitive function, daily functioning, emotional status, and social support will be assessed before and after the intervention.",[27],"2026-07-11",{"date":553,"type":47},{"date":444,"type":21},{"date":605,"type":21},"2026-10-28",{"name":607,"class":54},"Anhui Medical University",{"id":609,"slug":610,"hasResults":12,"nctId":611,"briefTitle":612,"officialTitle":613,"acronym":614,"eligibilityCriteria":615,"healthyVolunteers":12,"sex":18,"minAge":206,"maxAge":231,"enrollmentInfo":616,"targetDuration":4,"studyType":98,"phases":618,"briefSummary":619,"conditions":620,"keywords":621,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":629,"lastUpdatePostDateStruct":630,"startDateStruct":632,"completionDateStruct":634,"leadSponsor":635,"locationsCount":84},"100644702","effects-of-hydroxytyrosol-rich-olive-polyphenol-dietary-supplement-combined-with-mediterranean-diet-adherence-on-the-cognitive-health-of-patients-with-mild-cognitive-impairment-100644702","NCT07672938","Effects of Hydroxytyrosol-Rich Olive Polyphenol Dietary Supplement Combined With Mediterranean Diet Adherence on the Cognitive Health of Patients With Mild Cognitive Impairment","Hydroxytyrosol-Rich Olive Juice Polyphenol and Mediterranean Diet (The MEDIPHENO-HTrial) in Prevention of Cognitive Decline in Community-Dwelling Patients With Mild Cognitive Impairment: A Double-Blind, Placebo-Controlled, 3-Arm, Randomised Controlled Clinical Study","MEDIPHENO-HT","Inclusion Criteria:\n\n* GR-based men and women aged 50 - 85\n* Willingness and ability to conform to the full protocol.\n* Ability to accept and sign the consent form.\n* Presence of a diagnostic classification of Mild Cognitive Impairment according to the National Institute on Aging and Alzheimer's Association (NIA-AA) framework MCI, which corresponds to stage 3 on the pre-dementia range.\n* MoCA score of ≥18 and ≤ 26. Or\n* MMSE (Mini-Mental State Examination) score of ≥26 and ≤ 28.\n* No active suicide ideation based on the Columbia-Suicide Severity Rating Scale.\n* Absence of severe depressive symptomatology based on the Geriatric Depression Scale-15.\n* Not using any laxative drugs for at least three days prior to the screening visit.\n* Information about APOE status\n\nExclusion Criteria:\n\n* Patients with mild, moderate, or severe dementia.\n* Current or recent (within the last 4 weeks) engagement with a strict dietary regime i.e., vegetarian \u002F vegan \u002F ketogenic \u002F paleolithic \u002F high protein \u002F weight loss.\n* Any known issues with blood taking.\n* Any known bleeding disorders.\n* Any known allergy to olives, inability to tolerate gluten or multiple allergies\u002Fintolerances that would significantly limit food intake.\n* Average alcohol use of \\>21 glasses per week for men and \\>14 glasses per week for women (on average for the last six months).\n* History of psychiatric illness including intellectual disability, schizophrenia, bipolar disorder, severe, active depression and alcoholism.\n* Neurologic conditions such as vascular dementia, movement disorders, history of conditions such as anaemia and cancer in the last five years, renal or liver failure, malignant tumours, or organ transplant.\n* Coffee consumption greater than 5 cups per day.\n* Body mass index \\> 35 kg\u002F m2.\n* Not taking a stable dose of statins for at least 3 months before the recruitment visit. Taking antibiotics in the 1 week preceding the recruitment visit.\n* Pregnancy or lactation.\n* Participation in another clinical trial during the last 30 days prior to the recruitment visit.\n* Subject taking supplements that may affect lipoprotein metabolism, \\>1 g of fish oil\u002Fday, antioxidant supplements, cannabidiol (CBD) oil.",{"count":617,"type":21},141,[100],"Nutrition is an important modifiable risk factor of human cognitive health. Increasing data suggests that certain nutrients or food ingredients, such as plant polyphenols, have the potential to benefit cognitive abilities even in later life. In terms of polyphenols, Hydroxytyrosol (HT) has gained health benefit claims as a potential preventative antioxidant supplementation of neurodegenerative and amyloid-associated diseases while its pharmacological mechanisms suggest protection against cognitive decline. The primary objective of this study will be to evaluate the effects of HT-rich olive juice polyphenol supplementation alongside MeDi adherence compared with placebo alongside MeDi adherence in the prevention of cognitive decline among patients with Mild Cognitive Impairment associated with AD and non-AD pathology.",[27],[622,623,624,625,626,627,628],"Dementia Prevention","Phenolic-rich Nutritional Intervention","Hydroxytyrosol","Mediterranean Diet","Neurodegenerative Biomarkers","Public Health","Clinical Trial","2026-06-28",{"date":631,"type":47},"2026-06-30",{"date":633,"type":47},"2025-03-31",{"date":221,"type":21},{"name":636,"class":54},"Panhellenic Federation of Alzheimer's Disease and Related Disorders",{"id":638,"slug":639,"hasResults":12,"nctId":640,"briefTitle":641,"officialTitle":642,"acronym":4,"eligibilityCriteria":643,"healthyVolunteers":12,"sex":18,"minAge":206,"maxAge":231,"enrollmentInfo":644,"targetDuration":4,"studyType":98,"phases":646,"briefSummary":647,"conditions":648,"keywords":651,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":654,"lastUpdatePostDateStruct":655,"startDateStruct":657,"completionDateStruct":659,"leadSponsor":661,"locationsCount":663},"100595024","phase-2-study-to-evaluate-the-efficacy-and-safety-of-kds2010-in-patients-with-alzheimers-disease-with-mild-cognitive-impairment-and-mild-dementia-due-to-alzheimers-disease-100595024","NCT07027072","Study to Evaluate the Efficacy and Safety of KDS2010 in Patients With Alzheimer's Disease With Mild Cognitive Impairment and Mild Dementia Due to Alzheimer's Disease","A Randomized, Double-Blind, Placebo-Controlled, Dose-Finding, Phase 2a Clinical Trial to Evaluate the Efficacy and Safety of KDS2010 in Patients With Alzheimer's Disease With Mild Cognitive Impairment and Mild Dementia Due to Alzheimer's Disease","Inclusion Criteria:\n\n* Male and female adults aged ≥50 and ≤85 years at the time of written consent\n* Patients with MCI or mild AD confirmed at screening according to the 2024 diagnostic criteria (APPENDIX 1) of the National Institute on Aging-Alzheimer's Association (NIA-AA)\n* Subjects whose total CDR score (CDR-GS) is 0.5 to 1.0 at screening (however, CDR memory score is ≥0.5)\n* Subjects with a Mini-Mental State Examination (MMSE) score of 21 to 30 at screening\n* Subjects who test positive for amyloid on Positron Emission Tomography (PET) during screening\n* Subjects who have a caregiver capable of providing accurate information about the subject's cognitive and functional abilities and appropriate for the planned assessments in the study, as judged by the investigator\n* Subjects (or their legal representatives) who have voluntarily agreed to participate in this study and have given written consent\n\nExclusion Criteria:\n\n* Cognitive impairment or dementia due to causes other than Alzheimer's disease\n\n  * Vascular dementia, central nervous system infections (e.g., HIV, syphilis, etc.), head trauma, Creutzfeldt-Jakob disease, Pick's disease, Huntington's disease, Parkinson's disease, subdural hematoma, normal pressure hydrocephalus, brain tumor, thyroid disorders, parathyroid disorders, Vitamin B12 deficiency, folic acid deficiency, other metabolic and nutritional deficiencies, etc.\n  * Alcohol or drug abuse, dependence\n* Subjects with cognitive impairment due to hypothyroidism, nutritional deficiencies, Vitamin B12 or folic acid deficiency as assessed during screening\n* Subjects confirmed during screening to have had the following medical history:\n\n  * Malignant tumors within five years prior to screening except for basal cell carcinoma, cutaneous squamous cell carcinoma, thyroid cancer, or carcinoma in situ that has not recurred in over three years and is considered successfully treated by the investigator\n  * History of alcohol or drug abuse within two years prior to screening\n  * Loss of consciousness of unknown cause, or seizure within the past 52 weeks before screening\n  * Unstable and clinically significant cardiovascular diseases despite appropriate treatment (acute coronary syndrome (ACS), tachycardia, clinically significant arrhythmias, cardiomyopathy, angina of at least CSS III, heart failure of NYHA II-IV, or clinically significant valvular heart disease) within 24 weeks before baseline\n  * Severe or active infectious diseases requiring antibiotics or antivirals within four weeks before baseline\n  * A history of stroke involving a major vascular area, transient ischemic attack (TIA), epilepsy, or severe head trauma with loss of consciousness\n  * Hypersensitivity or allergy to any components of the investigational product\n* Subjects confirmed during screening to have had the following accompanying disease:\n\n  * Clinically significant neurological diseases or serious pathological findings affecting cognitive function as confirmed by brain imaging studies within 52 weeks prior to screening, including multiple sclerosis, normal pressure hydrocephalus, brain tumor (however, exceptions are allowed for lesions diagnosed as benign and with a maximum diameter of less than 1 cm), spinal cord infarction, major hemorrhage (defined as having a diameter \\> 1 cm in MRI) or subdural hemorrhage, cerebral vascular malformation, communicating hydrocephalus, inflammatory demyelinating diseases, etc.\n  * Uncontrolled hypertension despite appropriate treatment at screening or baseline (SBP ≥160 mmHg or DBP ≥100 mmHg)\n  * Dizziness or fainting when standing due to orthostatic hypotension that may affect the evaluation according to the judgment of the investigator\n  * Uncontrolled diabetes (HbA1c \\> 9%) during screening, despite appropriate treatment\n  * Bleeding disorders (Platelet \\\u003C50,000\u002Fmm³) during screening, despite appropriate treatment\n  * Patients with severe hepatic impairment (Child-pugh class C) at screening\n  * Following laboratory test values at screening:\n\n    * AST or ALT \\> 2.5 x ULN\n    * total bilirubin \\> 1.5 x ULN (however, in case of Gilbert syndrome, \\> 3.0 mg\u002FdL)\n    * MDRD eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m²\n  * QTcF interval \\>450 msecs for male or 470 msecs for female(12-lead ECG) during screening\n  * Gastrointestinal diseases that may affect oral administration or absorption (celiac disease, Crohn's disease, intestinal resection, etc.)\n  * Gastrointestinal diseases, including gastric and duodenal ulcers, that may affect the safety evaluation according to the judgment of the investigator\n  * Psychiatric diagnosis or symptoms that may interfere with the study (uncontrolled major depression, uncontrolled schizophrenia, uncontrolled bipolar affective disorder, etc.), as assessed by the investigator\n  * Positive responses to items 4 or 5 on the Columbia University Suicide Severity Rating Scale (C-SSRS) during screening\n  * Other conditions deemed by the investigator to potentially affect the outcome of the study\n* Subjects who have undergone or require treatment with the following:\n\n  * AD disease-modifying agents (aducanumab, lecanemab, donanemab, gantenerumab, solanezumab, blarcamesine, simufilam, tricaprilin, valiltramiprosate, etc.) within 12 weeks before screening\n  * Medications that may improve cognitive abilities or affect AD treatment (AChEIs, donepezil, galantamine, rivastigmine, tacrine, memantine, etc.) within 12 weeks before screening, except if the subject has been on a stable dose for at least 12 weeks before baseline and maintains the same composition\u002Fdosage\u002Fmethod of administration during the study period\n  * CNS-active drugs or those affecting cognitive function antidepressants other than serotonergic drugs \\[e.g., bupropion\\], sedatives \\[e.g., carbamazepine\\], dopamine antagonists \\[e.g., antipsychotics, metoclopramide\\], amfepramone, mazindol) within 12 weeks before screening\n  * Central anticholinergics and sedating H1-antihistamines within 12 weeks before screening.\n\nHowever, exceptions are allowed for one-time use of the drugs, such as second-generation H1 antihistamines (e.g., cetirizine, levocetirizine, etc.) or peripheral anticholinergics with no central action (e.g., trospium for treating overactive bladder). But the use is prohibited for at least 3 days from the date of cognitive function evaluation.\n\n* Other investigational products or clinical trial devices within four weeks before baseline or five times the half-life of the drug (whichever is longer, and patients can be enrolled after wash-out)\n* Monoamine oxidase inhibitors (MAOIs) and linezolid within two weeks before baseline or five times the half-life of the drug (whichever is longer, and patients can be enrolled after wash-out)\n* Opioids (pethidine, tramadol, tapentadol, etc.) within two weeks before baseline or five times the half-life of the drug (whichever is longer, and patients can be enrolled after wash-out)\n* Cyclobenzaprine and St. John's wort within two weeks before baseline or five times the half-life of the drug (whichever is longer, and patients can be enrolled after wash-out)\n* The following serotonergic drugs within two weeks before baseline or five times the half-life of the drug (whichever is longer, and patients can be enrolled after wash-out),\n\n  * selective serotonin (5HT1) agonists\n  * lithium\n  * lamotrigine\n  * ritonavir\n  * dapoxetine\n  * Selective serotonin reuptake inhibitors (SSRIs)\n  * dapoxetine\n  * Serotonin-norepinephrine reuptake inhibitors (SNRIs)\n  * Tricyclic or tetracyclic antidepressants\n  * triazolopyridine antidepressant However, amitriptyline ≤ 50 mg\u002Fday, trazodone ≤ 100 mg\u002Fday, citalopram ≤ 20 mg\u002Fday, and sertraline ≤ 100 mg\u002Fday are allowed without washout.\n* Use of sympathomimetics (ephedrine, methylphenidate, amphetamine, methamphetamine, lisdexamfetamine, etc.) during the screening period\n* Use of Dextromethorphan during the screening period\n* Use of CYP3A4 strong inducer, CYP3A4 strong inhibitor, CYP2D6 strong inducer, and CYP2D6 strong inhibitor during the screening period\n\n  * Inability to undergo MRI or PET scans\n  * Pregnant or breastfeeding women\n  * Fertile women or men who are unwilling to use effective contraception\\* from the date of written consent until 12 weeks after the last administration of the investigational product\n\n    \\*Effective contraception is defined as follows, and at least one method should be used:\n    * Hormonal contraception (oral, injectable, implantable, etc.)\n    * Intrauterine device (IUD) or system (IUS)\n    * Sterilization or surgical procedures (vasectomy, bilateral tubal ligation\u002Fsurgery, hysterectomy)\n    * Dual contraception methods: Simultaneous use of barrier methods (male condoms) with the methods listed above\n    * Absolute abstinence: Total abstinence from sexual intercourse is recognized if the investigator deems the subject's age, occupation, lifestyle, or sexual orientation assures contraception. However, periodic abstinence (calendar method, mucus method, and symptothermal method), withdrawal, and coitus interruptus are not recognized as effective contraception methods.\n  * Other conditions deemed by the investigator to be unsuitable for participation in the study",{"count":645,"type":21},114,[304],"A randomized, double-blind, placebo-controlled, dose-finding Phase 2a clinical trial will be conducted to evaluate the efficacy and safety of KDS2010 in patients with Mild Cognitive Impairment (MCI) due to Alzheimer's disease (AD) and mild dementia due to Alzheimer's disease.\n\nBased on preliminary efficacy observed in the Phase 1 clinical trial, a clinical trial will be conducted in Korea. Eligible patients diagnosed with MCI or mild Alzheimer's disease will be stratified by disease stage (MCI\u002Fmild AD) prior to randomization. Subjects will be randomly assigned in a 1:1:1 ratio to either Treatment Group 1, Treatment Group 2, or the Control Group. The investigational product will be administered orally once daily for a duration of 24 weeks. Approximately 114 subjects will be enrolled, including an estimated 20% dropout rate, with 38 subjects assigned to each group (Treatment Group 1, Treatment Group 2, and Control Group).\n\nThe objectives of the study are as follows:\n\n1. Efficacy Objectives: Efficacy will be evaluated through changes in cognitive function, self-management, and daily living activities before and after administration of KDS2010. Biomarker analysis in plasma and in cerebrospinal fluid (CSF; optional) will also be conducted to explore treatment efficacy.\n2. Safety Objectives: The safety and tolerability will be evaluated after administration of KDS2010.\n3. Exploratory Objectives: The efficacy of Treatment Groups 1 and 2 compared to the Control group will be explored through cognitive endpoints (the Clinical Dementia Rating-Sum of Boxes (CDR-SB), the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog13), and the Mini-Mental State Examination (MMSE)), stratified by demographic information, tauopathy, and ApoE4 genes.\n\nBased on nonclinical and Phase 1 clinical data, KDS2010 will be administered orally once daily at two dose levels: 60 mg and 120 mg.",[27,649,650],"Mild Dementia","Alzheimer's Disease",[165,649,652,653,650],"KDS2010","MAO-B inhibitor","2026-06-17",{"date":656,"type":47},"2026-06-22",{"date":658,"type":47},"2025-08-06",{"date":660,"type":21},"2027-12-31",{"name":662,"class":83},"NeuroBiogen Co., Ltd",8,{"id":665,"slug":666,"hasResults":12,"nctId":667,"briefTitle":668,"officialTitle":669,"acronym":4,"eligibilityCriteria":670,"healthyVolunteers":12,"sex":18,"minAge":327,"maxAge":300,"enrollmentInfo":671,"targetDuration":4,"studyType":98,"phases":672,"briefSummary":673,"conditions":674,"keywords":676,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":681,"lastUpdatePostDateStruct":682,"startDateStruct":684,"completionDateStruct":685,"leadSponsor":687,"locationsCount":84},"100641111","the-cognitive-protective-effect-of-vr-based-cognitive-training-in-type-2-diabetes-patients-with-mild-cognitive-impairment-100641111","NCT07650318","The Cognitive Protective Effect of VR-based Cognitive Training in Type 2 Diabetes Patients With Mild Cognitive Impairment","The Cognitive Protective Effect of VR-based Cognitive Training in Type 2 Diabetes Patients With Mild Cognitive Impairment：A Prospective, Randomized, Open-Label, Parallel-Group Pilot Study","Inclusion Criteria:\n\n1. Aged 45-80 years; gender is not restricted;\n2. Participants must meet the diagnostic criteria for diabetes outlined in the \\*Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes (2020 Edition)\\*, namely: patients exhibit typical symptoms of diabetes and meet one of the following conditions: 1) HbA1c ≥ 6.5%; 2) Fasting blood glucose ≥7.0 mmol\u002FL. Fasting is defined as no caloric intake for at least 8 hours; 3) 2-hour postprandial blood glucose ≥11.1 mmol\u002FL following an oral glucose tolerance test; 4) Random blood glucose ≥11.1 mmol\u002FL;\n3. Stable glycemic control regimen for 3 months or longer;\n4. Completed a systematic neuropsychological assessment and met the MCI diagnostic criteria outlined in the 2018 American Academy of Neurology Guidelines for Mild Cognitive Impairment, satisfying the following conditions: 1) The patient or a caregiver subjectively perceives a decline in cognitive function; 2) Assessment results indicate impairment in one or more cognitive domains; 3) There is mild impairment in complex instrumental activities of daily living, but the patient maintains independence in basic activities of daily living; 4) Does not yet meet the diagnostic criteria for dementia;\n5. Has an educational level of elementary school or higher and is able to cooperate in completing the assessment, VR training, and various examinations;\n6. Cooperate in undergoing magnetic resonance imaging (MRI) examinations;\n7. Voluntarily participates in this study, signs an informed consent form, and is able to comply with the study protocol requirements to complete follow-up.\n\nExclusion Criteria:\n\n1. Suffering from other dementia-related neurological disorders (such as Alzheimer's disease, Parkinson's disease, etc.) or severe mental illness;\n2. History of central nervous system disorders, including traumatic brain injury, intracranial hemorrhage, acute cerebral infarction, etc.;\n3. Severe sinusitis, space-occupying lesions in the nasopharynx, or congenital disorders affecting the sense of smell,or a history of trauma;\n4. Glaucoma, severe dry eye syndrome, uncorrected strabismus, severe diabetic retinopathy,or severe motion sickness, making the user unable to tolerate VR devices;\n5. History of acute diabetic complications within the past 3 months (diabetic ketoacidosis, hyperglycemic hyperosmolar state, severe hypoglycemia, etc.);\n6. Severe impairment of vital organ function, including cardiac, hepatic, or renal dysfunction;\n7. Pregnant or breastfeeding women, or women planning to become pregnant during the study;\n8. Contraindications for MRI scans, such as the presence of metallic prostheses, pacemakers, cochlear implants, or other metallic implants, or claustrophobia;\n9. Participation in other clinical trials currently or within the past 3 months;\n10. Known or suspected history of allergy to study-related materials;\n11. Currently taking medications intended to improve cognitive function.",{"count":209,"type":21},[100],"A single-center, prospective, open-label, parallel-group randomized controlled trial is conducted to investigate the cognitive-protective efficacy of a novel, diabetes-specific virtual reality (VR)-based cognitive training system integrated with diet management modules, relative to frequency- and duration-matched traditional paper-and-pencil cognitive training, in adults aged 45-80 years with T2DM and amnestic\u002Fmixed mild cognitive impairment (MCI). A total of 40 eligible participants are randomly assigned 1:1 to either the intervention group (16 weeks of individualized VR training with dynamic difficulty, 2 sessions\u002Fweek, 30-60 minutes\u002Fsession) or the active control group (standardized paper-and-pencil cognitive tasks). All participants maintain stable glucose-lowering regimens for ≥3 months and receive standardized weekly diabetes health education. The primary endpoint is the between-group difference in the change in MoCA total score from baseline to the 16-week follow-up. Secondary endpoints include changes in individual cognitive domains (memory, executive function, attention, processing speed), olfactory threshold\u002Fidentification\u002Frecall, brain structural volumes and resting-state functional connectivity (assessed via 3.0T fMRI), glycemic control (HbA1c, fasting\u002Fpostprandial glucose), lipid profile, body composition, sleep quality, anxiety and depressive symptoms, and diabetes self-management behaviors. The safety and participant adherence to the VR intervention are also systematically monitored.",[675,27],"Type 2 Diabetes Mellitus (T2DM)",[677,678,679,680],"Cognition","Cognitive training","Functional MRI","Virtual reality (VR) technology","2026-06-16",{"date":683,"type":47},"2026-06-18",{"date":219,"type":47},{"date":686,"type":21},"2028-06-01",{"name":688,"class":54},"The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School"]