[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07214974":3,"trial-entities:NCT07214974":121,"trial-summary:NCT07214974":127},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":29,"study_type":30,"primary_purpose":31,"phases":32,"enrollment_info":34,"interventions":37,"primary_outcomes":68,"secondary_outcomes":77,"sex":88,"minimum_age":89,"maximum_age":90,"healthy_volunteers":15,"eligibility_criteria":91,"std_ages":95,"locations":98,"central_contacts":108,"overall_officials":118,"references":119,"see_also_links":120},"NCT07214974","NoahTech","Mild Cognitive Impairment Community Screening and Early Intervention Via Stem Cell Therapy and Wearable Brain Computer Interface Device.","Mild Cognitive Impairment Community Screening, Early Detection, and Therapeutic Intervention to Slow Down, or Stop the Progression of the Cognitive Impairment.","NOT_YET_RECRUITING","2030-01-03","2026-03","2026-03-10","2026-09-01","Noah Tech, Corp.","INDUSTRY",true,"This study aims to evaluate the efficacy of community-based early detection and targeted interventions, including stem cell therapy and wearable non-invasive brain-computer interface (BCI) devices, for Mild Cognitive Impairment (MCI) in adults aged 55 years and older residing in U.S. urban and suburban communities. Primary objectives include assessing improvements in MCI detection rates, cognitive outcomes, and progression delay compared to standard care.","Study Objectives\n\nThe primary goal of this investigation is to assess the effectiveness of early MCI detection via community-based screening and subsequent interventions using stem cell therapy and wearable BCI devices. Specific research questions include:\n\nDoes community-based screening enhance early detection rates and diagnostic accuracy of MCI relative to conventional clinical practices? Do wellness care interventions post-MCI screening improve cognitive outcomes and delay progression to cognitive decline? What are the epidemiological characteristics and distribution patterns of MCI occurrence in the target population?\n\nStudy Design This is a prospective, multicenter, randomized, double-blind, placebo-controlled trial (RCT) designed to minimize bias and ensure methodological rigor.\n\nEligible participants will be identified through standardized cognitive screening (e.g., Montreal Cognitive Assessment \\[MoCA\\]) administered at community facilities and healthcare clinics. Inclusion criteria encompass adults aged ≥55 years with suspected or confirmed MCI, residing in U.S. urban or suburban areas, without contraindications to interventions. Exclusion criteria include severe dementia, active neurological disorders, or inability to provide informed consent.\n\nParticipants will be randomized to one of four parallel arms using a computer-generated sequence with stratified block randomization to balance covariates such as age, baseline MCI severity (e.g., MoCA score), and comorbidities. Allocation concealment will be maintained via sequentially numbered, opaque, sealed envelopes managed by an independent data coordinating center.\n\nThe intervention arms are defined as follows:\n\nArm 1 (Control): No active intervention; placebo procedures (e.g., saline infusions or sham devices) will be implemented to preserve blinding where applicable.\n\nArm 2 (Wellness Care): Structured wellness programs comprising cognitive training exercises and lifestyle counseling (e.g., diet, exercise, and sleep optimization), with sham components for blinding if required.\n\nArm 3 (Stem Cell Therapy): Administration of autologous or allogeneic stem cells via intravenous or targeted routes, with placebo saline infusions provided to non-stem cell arms.\n\nArm 4 (Wearable BCI Device Therapy): Use of an active non-invasive BCI device for neurofeedback training, with sham (non-functional) devices distributed to other arms.\n\nDouble-blinding will be achieved by ensuring that neither participants nor outcome assessors (e.g., neuropsychologists) are aware of group assignments. Intervention delivery will be handled by a separate team from the assessment personnel to prevent unblinding.\n\nFollow-up evaluations will include periodic cognitive assessments (e.g., MoCA, comprehensive neuropsychological batteries) at baseline, 6 months, 1 year, and annually thereafter for a total duration of 5 years. These will monitor trajectories in cognitive function, MCI progression rates, and secondary endpoints such as quality of life (e.g., via SF-36 questionnaire), neuroimaging biomarkers (e.g., MRI volumetric changes), and biochemical markers (e.g., CSF amyloid-beta levels).\n\nStatistical analysis will adhere to intention-to-treat principles. Inter-group comparisons will employ analysis of variance (ANOVA) or linear mixed-effects models for repeated measures, with adjustments for multiple comparisons (e.g., Bonferroni correction) and covariates. Survival analysis (e.g., Kaplan-Meier curves) will evaluate time-to-event outcomes, such as progression to dementia. Power calculations assume a sample size sufficient to detect a 20% difference in cognitive decline rates with 80% power and α=0.05.\n\nThis design facilitates an unbiased assessment of intervention efficacy in mitigating or reversing MCI progression, with potential implications for public health strategies in aging populations.\n\nLast updated: October 03, 2025",[19,20,21,22,23,24,25,26,27,28],"Mild Cognitive Impairment (MCI)","Early Stages of Cognitive Decline","Alzheimer's Disease Dementia","Alzheimer's Disease Diagnosis","Alzheimer's Disease and Related Dementias","Parkinson's Disease","Parkinson's Disease (PD)","Parkinson's Disease With Wearing-off Motor Fluctuations","Dementia (Diagnosis)","Dementia MCI (Mild Cognitive Impairment)",[],"INTERVENTIONAL","TREATMENT",[33],"EARLY_PHASE1",{"count":35,"type":36},600,"ESTIMATED",[38,48,56,62],{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":44},"BEHAVIORAL","Structured wellness care","Participants engage in structured wellness programs, including cognitive training exercises (e.g., memory games, problem-solving tasks) and lifestyle counseling focused on diet, physical exercise, sleep hygiene, and stress management. Sham elements may be included for blinding consistency.",[43],"Arm 2 (Wellness Care)",[45,46,47],"Brain-computer Interface (BCI)","Stem Cell","wearable BCI",{"type":49,"name":50,"description":51,"armGroupLabels":52,"otherNames":54},"DEVICE","Wearable brain-computer interface devices","Participants use an active non-invasive brain-computer interface (BCI) device for neurofeedback training, designed to enhance cognitive function through real-time brain activity monitoring and modulation. Sham (non-functional) devices are provided to other arms for blinding.",[53],"Arm 4 (Wearable BCI Device Therapy)",[55],"stem cell",{"type":57,"name":58,"description":59,"armGroupLabels":60},"BIOLOGICAL","Stem Cell Therapy - Experimental","Participants receive administration of autologous or allogeneic stem cells through intravenous or targeted delivery methods aimed at neuroregeneration. Placebo saline infusions are used in other arms to preserve blinding.",[61],"Arm 3 (Stem Cell Therapy)",{"type":63,"name":64,"description":65,"armGroupLabels":66},"OTHER","Control - Placebo Comparator","Participants receive no active treatment. To maintain blinding, they undergo placebo procedures, such as saline infusions mimicking stem cell therapy or sham (non-functional) devices simulating BCI therapy.",[67],"Arm 1 (Control)",[69,73],{"measure":70,"description":71,"timeFrame":72},"Change in Cognitive Function as Measured by MoCA Score","The primary endpoint is the mean change from baseline in Montreal Cognitive Assessment (MoCA) total score, assessing domains such as memory, attention, language, and executive function. A clinically meaningful improvement is defined as an increase of ≥3 points, while decline indicates progression. This measure evaluates the efficacy of interventions in stabilizing or enhancing cognitive performance.","Baseline, 6 months, 1 year, and annually up to 5 years.",{"measure":74,"description":75,"timeFrame":76},"Rate of Progression to Dementia","Proportion of participants progressing from MCI to dementia (e.g., Alzheimer's disease or other forms), diagnosed via DSM-5 criteria and confirmed by neuropsychological evaluation. This assesses intervention effectiveness in delaying or preventing cognitive decline.","Assessed annually over 5 years.",[78,81,84],{"measure":79,"description":80,"timeFrame":72},"Improvement in Neuropsychological Battery Scores","Changes in composite scores from a standardized neuropsychological test battery (e.g., including Rey Auditory Verbal Learning Test for memory, Trail Making Test for executive function, and Boston Naming Test for language). This provides detailed insights into specific cognitive domain improvements.",{"measure":82,"description":83,"timeFrame":72},"Change in Quality of Life","Assessed using the Short Form-36 (SF-36) questionnaire, focusing on physical and mental health components. This evaluates the broader impact of interventions on daily functioning and well-being.",{"measure":85,"description":86,"timeFrame":87},"Early Detection Rate via Community Screening","Proportion of MCI cases identified through community-based MoCA screening compared to historical rates from standard clinical practices in similar populations.","Enrollment phase (pre-randomization).","ALL","55 Years",null,{"inclusion":92,"exclusion":93,"raw_text":94},[],[],"Inclusion Criteria:\n\nAdults aged 55 years and older Residents of U.S. urban or suburban communities Able to provide informed consent Willing to participate in 3-year follow-up assessments Able to complete cognitive screening assessments Access to transportation for community-based appointments No prior formal diagnosis of dementia\n\nExclusion Criteria:\n\nAdults under 55 years of age Current diagnosis of moderate to severe dementia Severe psychiatric disorders that would interfere with assessment validity Active substance abuse disorders Severe visual or hearing impairments that cannot be corrected and would prevent assessment completion Terminal illness with life expectancy less than 3 years Current participation in other cognitive intervention research studies Inability to attend follow-up assessments due to geographic relocation plans Significant neurological conditions (stroke, traumatic brain injury, Parkinson's disease) that could confound cognitive assessment Institutionalized individuals (nursing home residents)",[96,97],"ADULT","OLDER_ADULT",[99],{"facility":100,"city":101,"state":102,"zip":103,"country":104,"geoPoint":105},"First Presbyterian Church","Palisades Park","New Jersey","07650","United States",{"lat":106,"lon":107},40.84816,-73.99764,[109,114],{"name":110,"role":111,"phone":112,"email":113},"Wallace Lynch, Ph.D.","CONTACT","6504895808","info@noahtech.life",{"name":115,"role":111,"phone":116,"email":117},"Patrick M, BS","9174437199","help@noahtech.life",[],[],[],{"nct_id":4,"conditions":122,"biomarkers":126},[123,124,125],"Alzheimer's Disease","Dementia","Mild cognitive disorder",[],{"nct_id":4,"found":15,"summary":128,"prompt_version":136},{"design":129,"status":130,"heading":6,"summary":131,"follow_up":129,"word_count":132,"commitments":133,"compensation":134,"drugs_mentioned":135},"Not specified.","completed","{\n   \"Mild Cognitive Impairment Study: Stem Cell Therapy and Brain-Computer Interface\",\n   \"This study is looking at new ways to help people with Mild Cognitive Impairment (MCI), which is an early stage of memory or thinking problems. It's testing if early detection in the community, along with treatments like stem cell therapy and a wearable brain-computer interface (BCI) device, can improve cognitive function and slow down the progression to dementia. The study aims to enroll 600 participants aged 55 and older who live in U.S. urban or suburban areas and have suspected or confirmed MCI. You cannot have a formal dementia diagnosis already. Success will be measured by changes in memory and thinking scores (MoCA score) and how many people progress to dementia over time. The current recruitment status is unclear.\",\n  \"design\": \"This is a large, randomized, double-blind, placebo-controlled study involving 600 participants. This means participants are randomly assigned to different groups, and neither you nor the study staff will know which treatment you are receiving.\",\n  \"commitments\": \"You would participate in structured wellness programs, potentially use a wearable brain-computer interface device, and might receive stem cell therapy or a placebo. You would have cognitive assessments at baseline, 6 months, 1 year, and annually for up to 5 years.\",\n  \"compensation\": \"Not stated in the trial record.\",\n  \"follow_up\": \"Participants will be followed for up to 5 years, with annual assessments to track cognitive function and progression to dementia.\",\n}",236,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]