[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mci-ad-early-stage-alzheimer39s-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mci-ad-early-stage-alzheimer39s-disease":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,40],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":4},"100608056","development-of-a-novel-multidimensional-therapeutic-intervention-protocol-for-mci-100608056",false,"NCT07196592","Development of a Novel Multidimensional Therapeutic Intervention Protocol for MCI","AD New Multi-Dimensional Therapy Device Development - Microcurrent Brain Stimulation Device and Virtual Reality Therapy Equipment","Inclusion Criteria:\n\nBaseline screening inclusion criteria: a) Age ≤ 65 years and ≤ 85 years; b) Education duration ≥ 1 year; c) Normal cognitive function at enrollment: MMSE total score: non-illiterate (primary school or below) ≥ 20 points, primary school or above ≥ 24 points; d) Corrected vision and hearing are basically normal, and able to complete cognitive assessment.\n\nExclusion Criteria:\n\nBaseline screening exclusion criteria: a) Neurological\u002Fpsychiatric disorders affecting cognitive function: depression, schizophrenia, mental retardation, Parkinson's disease, etc.; b) Severe physical illnesses: cardiovascular disease, cerebrovascular disease, tumors, diabetes, kidney disease, and hypertension stage III or above; c) Autoimmune inflammatory diseases such as rheumatoid arthritis, lupus erythematosus, osteoarthritis, and multiple sclerosis.",true,"ALL","60 Years",{"count":20,"type":21},300,"ESTIMATED","INTERVENTIONAL",[24],"NA","As populations age, Alzheimer's disease (AD) is increasing while disease-modifying drugs remain elusive, making early diagnosis and intervention essential. Building on advances in neuromodulation and virtual reality (VR), we target amnestic mild cognitive impairment (aMCI)-the prodromal stage of AD-as a key window for prevention. Preliminary evidence shows disrupted theta-delta phase-amplitude coupling in prefrontal and temporal cortices in aMCI, whereas olfactory enrichment can enhance hippocampal synaptic function, improve cognition, and potentially lower AD risk. We will conduct a large-scale clinical cohort study to test the neural mechanisms and clinical efficacy of multi-site, cross-frequency transcranial alternating current stimulation (tACS) combined with multisensory (visual-olfactory-auditory) VR. A comprehensive database spanning demographic, neuropsychological, biochemical, neuroimaging, and neuromodulation parameters will guide optimal protocols and provide objective evidence for non-pharmacological interventions, informing development of a microcurrent brain stimulator and a portable VR device.",[27],"MCI-AD, Early Stage Alzheimer's Disease","NOT_YET_RECRUITING","2025-09-20",{"date":31,"type":32},"2025-09-29","ACTUAL",{"date":34,"type":21},"2025-10-01",{"date":36,"type":21},"2026-12-01",{"name":38,"class":39},"Yuan Shen","OTHER",{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":17,"minAge":46,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":50,"phases":4,"briefSummary":51,"conditions":52,"keywords":54,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":4},"100582801","efficacy-and-safety-of-conventional-symptomatic-drugs-combined-with-lencanizumab-in-the-treatment-of-early-alzheimers-disease-a-multicenter-prospective-observational-study-100582801","NCT06868030","Efficacy and Safety of Conventional Symptomatic Drugs Combined with Lencanizumab in the Treatment of Early Alzheimer's Disease: a Multicenter, Prospective, Observational Study","Inclusion Criteria:\n\n1. Patients aged 50 and 85 years old, male or female;\n2. The subjects had primary school education (education) or above, normal hearing, vision and pronunciation, native tongue is Chinese, and daily language is Mandarin, and were able to complete the information collection stipulated in the program.\n3. The AD diagnosis met the diagnostic criteria for dementia described in the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-R), using the 2011 NIA-AA AD diagnostic criteria. The MCI diagnosis met the MCI diagnostic criteria of Peterson in 2004;\n4. The presence of amyloid deposits was confirmed by biomarkers: imaging or cerebrospinal fluid biomarkers.\n5. Having cognitive decline, having one of the following conditions: (a) MMSE score of 20 or above; (b) CDR-GS score of 0.5 or 1;\n6. The combination group met the criteria for cainumab (according to cainumab instructions);\n7. Willing and able to complete all the requirements of the study (including MRI, neuropsychological assessment, clinical genotyping, etc.);\n8. Established caregivers or family members can objectively conduct CDR, quality of life scale, daily life performance scale and other clinical assessments;\n9. The patient and their family members were informed and signed the informed consent form.\n\nExclusion Criteria:\n\n1. There are other neurological diseases that can cause brain dysfunction (such as depression, brain tumors, Parkinson's disease, metabolic encephalopathy, encephalitis, multiple sclerosis, epilepsy, brain trauma, normal skull pressure hydrocephalus, etc.);\n2. There are other systemic diseases that can cause cognitive impairment (such as liver insufficiency, renal insufficiency, thyroid dysfunction, severe anemia, folic acid or vitamin B12 deficiency, syphilis, HIV infection, alcohol and drug abuse, etc.);\n3. Presence of serious or unstable diseases, including cardiovascular, hepatic, renal, gastrointestinal, respiratory, endocrine, neurological (except AD), psychiatric, immune, or hematological diseases and other diseases that the investigator believes may affect the results of the study analysis, or a life expectancy of \\\u003C24 months;\n4. History of schizophrenia, schiztive disorder, major depression or bipolar disorder, and history of major depression may be enrolled in the study if no episodes occurred or mitigated or controlled in the past year; risk of suicide; a history of alcoholism and \u002F or substance abuse or dependence in the past 2 years (according to the Diagnostic and Statistical Manual of Mental Disorders, Version 5th standard)\n5. Severe stroke sequelae (mRS\\> 3 or previous stroke history);\n6. Clinically significant systemic immune participants due to the sustained effects of immunosuppressive drugs;\n7. Failure to tolerate MRI tests or with MRI contraindications, including but not limited to: a pacemaker incompatible with MRI, eye, skin, MRI clips, artificial heart valve, ear implant, or external metal implant, or other clinical history or findings of which MRI may cause potential harm;\n8. Subjects with a history of allergy to any treatment component such as cincainizumab;\n9. Refusal to sign the informed consent form.","50 Years","85 Years",{"count":49,"type":21},120,"OBSERVATIONAL","According to the World Health Organization, China will become the \"oldest\" country in the world by 2050, with 35 percent of the elderly population. At present, in the Chinese population of 60 years old, there are about 15.07 million dementia patients (about 6.0%), about 9.83 million Alzheimer's disease (AD) patients (about 3.9%), and about 38.77 million mild cognitive impairment (Mild cognitive impairment, MCI) patients (about 15.5%). A sharp increase in older people with cognitive impairment will bring a heavy disease burden, and the social cost is almost the sum of cancer, heart disease and stroke.\n\nAD is an age-related neurodegenerative disorder characterized by a progressive decline in cognitive function and daily living capacity. The amyloid hypothesis of AD suggests that the deposition of A β is an early and inevitable event in AD pathogenesis. This hypothesis suggests that therapies that slow the deposition of A β plaques in the brain or increase the clearance of A β may slow the progression of the AD clinical syndrome. Most of the disease course of patients with cognitive impairment is more than 10 years long. How to diagnose and treat them in the early stage has become a key link to delay the progression of the disease and reduce the burden. The disease progression of AD is divided into three major stages: preclinical AD (Preclinical AD, Pre-AD), AD-derived mild cognitive impairment (Mild cognitive impairment due to AD, MCI-AD) and AD dementia (which can be subdivided into mild, moderate and severe AD). Among them, MCI-AD and mild AD are collectively known as early AD, which are the earliest clinical symptoms and the best window for identification and intervention. Studies show that about 43.4% of patients with MCI-AD will progress to AD dementia within 4 years, and 80% will progress within 6 years. If the disease advances to moderate or severe AD, patients will develop severe cognitive, functional impairment and behavioral symptoms, which interfere with social function and need help from daily living activities; severe or even complete loss of independence, requiring round-the-clock care. If early diagnosis and effective interventions in the early stages of the disease, it will help delay the disease into the moderate and severe stages, prolong the quality of life of patients, and greatly reduce the social burden of care and treatment.\n\nAt present, the treatment of AD is mainly symptomatic treatment, mainly including cholinesterase inhibitors and NMDA receptor antagonists. Phase-phase clinical trials show that luncinelizumab has a positive impact on cognitive function and pathological indicators in patients with early AD, delaying the early AD disease process by up to 27% relative to placebo treatment. Lencanizumab, a disease-modifying therapy for early AD, has been approved by FDA and NMPA in China. With the wide clinical application, the clinical efficacy and safety of lencanizumab combined with classical symptomatic therapy have attracted great attention. However, there are still few studies on the clinical characteristics, diagnosis and treatment patterns, efficacy and safety of the combination, and clinical outcomes of patients with early AD in the real world.\n\nBased on this, this study intends to conduct an 18-month multi-center prospective real-world observational cohort study exploring the clinical characteristics, diagnosis and treatment patterns, efficacy and safety of the combination, caregiver and family burden of real-world early AD patients (MCI-AD and mild AD).",[53,27],"Alzheimer's Disease",[55,56,57,58],"Alzheimer disease","MCI-AD, early stage Alzheimer's disease","lencanizumab","treatment","2025-03-05",{"date":61,"type":32},"2025-03-10",{"date":63,"type":21},"2025-04-01",{"date":65,"type":21},"2026-12-31",{"name":67,"class":39},"First Hospital of China Medical University"]