[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Zhejiang Provincial Tongde Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":74},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,50],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100642856","silkworm-pupa-powder-improves-alzheimers-disease-100642856",false,"NCT07638449","Silkworm Pupa Powder Improves Alzheimer's Disease","A Prospective, Single-Arm Study Evaluating Silkworm Pupa Powder in Improving Alzheimer's Disease Among Patients","Inclusion Criteria:\n\n* Diagnosis of probable Alzheimer's disease (AD) according to the National Institute on Aging-Alzheimer's Association (NIA-AA) criteria. Disease severity is classified as mild to moderate, defined as a Mini-Mental State Examination (MMSE) total score of 0-24 points, inclusive, at both screening and baseline.\n* Confirmation of AD pathology per the 2024 revised AD diagnostic criteria (biomarker-defined AD with both Aβ and tau positivity):\n* Aβ positivity: Plasma Aβ42\u002F40 ratio ≤0.08 or amyloid-PET positivity (SUVR ≥1.1).\n* Tau positivity: Plasma p-tau217 ≥2.5 pg\u002FmL (or CSF p-tau181\u002FAβ42 ratio ≥0.02).\n* Age 50 to 90 years (inclusive), male or female, with at least a primary school education.\n* Stable medication use: If receiving approved AD therapies (e.g., acetylcholinesterase inhibitors, GV-971, NMDA receptor antagonists), doses must remain stable for ≥12 weeks prior to baseline. Treatment-naïve participants are also eligible. All other permitted non-AD related concomitant medications must remain stable for ≥4 weeks prior to baseline unless otherwise specified.\n* Hachinski Ischemia Scale (HIS) total score ≤4.\n* Geriatric Depression Scale-15 (GDS-15) total score ≤4.\n* Neuroimaging evidence: Screening CT\u002FMRI showing age-related brain changes or cerebral atrophy.\n* Participant has a stable and reliable caregiver, as confirmed by the investigator.\n* Written informed consent must be provided by the participant or, if the participant lacks decision-making capacity, by a legally authorized representative (in accordance with local laws, regulations, and customs). Participants must agree to provide peripheral blood, stool, and urine samples during the study for biomarker analysis.\n\nExclusion Criteria:\n\n* Diagnosis of dementia other than Alzheimer's disease (AD) or other central nervous system disorders.\n* Unstable vital signs accompanied by abnormalities in cardiac, pulmonary, hepatic, renal, or other organ functions.\n* Abnormally low folate and\u002For vitamin B12 levels, or evidence that hypothyroidism has caused or exacerbated the participant's dementia. Abnormal syphilis test results.\n* Comorbid psychiatric disorders.\n* Long-term alcoholism or substance abuse that may compromise the evaluation of treatment efficacy.\n* Intolerance or allergy to the study medication (silkworm pupa powder).\n* Abnormalities detected on cranial MRI, including ischemic or hemorrhagic infarctions, hydrocephalus, or brain tumors.\n* Diagnosis of clinically significant cardiovascular or cerebrovascular disease requiring treatment within 12 months or at present.\n* Geriatric Depression Scale-15 (GDS-15) score \\>4 at screening.\n* Any other inadequately controlled condition (e.g., cardiac, respiratory, renal, or gastrointestinal disorders affecting absorption, such as gastric cancer, gastric bypass surgery, or recurrent diarrhea) that may jeopardize participant safety or interfere with study assessments, as judged by the investigator.\n* Administration of any new chemical entity in an AD clinical study within 6 months prior to screening.\n* Clinically significant abnormalities in physical examination, vital signs, laboratory tests, or electrocardiogram (ECG) requiring further investigation, treatment, or posing risks to study procedures or safety.\n* Participation in a clinical study involving therapeutic monoclonal antibodies, antibody-derived proteins, immunoglobulin therapy, or vaccines within 6 months prior to screening.\n* Participation in a clinical study involving any anti-amyloid therapies (including any monoclonal antibody therapy and any BACE inhibitor therapy).\n* Any inadequately controlled immune disorder, or immune disease requiring treatment with immunoglobulins, systemic monoclonal antibodies (or derivatives), systemic immunosuppressants, or plasmapheresis during the study.\n* Inadequately controlled bleeding disorders (including platelet count \\\u003C50,000 or INR \\>1.5 for participants not on anticoagulants, e.g., warfarin). Participants on anticoagulants must have their anticoagulation status optimized and receive a stable dose within 4 weeks prior to screening. Participants receiving anticoagulant therapy must not participate in cerebrospinal fluid (CSF) assessments.\n* Participation in another concurrent silkworm pupa powder intervention study conducted at the same study center.","ALL","50 Years","90 Years",{"count":20,"type":21},100,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this clinical trial is to learn if silkworm pupa powder works to treat Alzheimer's disease in patients. It will also learn about the safety of silkworm pupa powder, and its effect on patients' nutritional and frailty status. The main questions it aims to answer are:\n\n* Does silkworm pupa powder improve cognitive function and daily living abilities?\n* Does silkworm pupa powder improve nutritional status and frailty?\n* What medical problems do participants have when taking silkworm pupa powder?\n\nResearchers will evaluate the treatment by comparing the participants' conditions after taking the powder to their baseline conditions (a single-arm study without a placebo) to see if silkworm pupa powder works to treat Alzheimer's disease.\n\nParticipants will:\n\n* Take silkworm pupa powder every day for 12 weeks\n* Visit the clinic once every 4 weeks for checkups and tests\n* Use an electronic punch-card system daily and report any symptoms",[27,28,29,30],"Alzheimer Disease","Sarcopenia","Asthenia","Frailty",[32,33,34,35,36],"Silkworm Pupa Powder","Nutritional Status","Frailty State","Cognitive Function","Dietary Supplement","NOT_YET_RECRUITING","2026-06-04",{"date":40,"type":41},"2026-06-10","ACTUAL",{"date":43,"type":21},"2026-06-01",{"date":45,"type":21},"2027-12-31",{"name":47,"class":48},"Zhejiang Provincial Tongde Hospital","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":73,"locationsCount":49},"100585139","silkworm-pupa-powder-improves-dementia-100585139","NCT06898476","Silkworm Pupa Powder Improves Dementia.","A Prospective, Double-Blind, Randomized Controlled Trial Evaluating Silkworm Pupa Powder Versus Placebo in Improving Alzheimer's Disease Among Patients","Inclusion Criteria:\n\n* Diagnosis of probable Alzheimer's disease (AD) according to the National Institute on Aging-Alzheimer's Association (NIA-AA) criteria, with disease severity classified as mild, moderate, or severe (i.e., Mini-Mental State Examination \\[MMSE\\] total score between 0 and 24 points \\[inclusive\\] at screening and baseline).\n* Confirmation of AD pathology per the 2024 revised AD diagnostic criteria (biomarker-defined AD with both Aβ and tau positivity):\n* Aβ positivity: Plasma Aβ42\u002F40 ratio ≤0.08 or amyloid-PET positivity (SUVR ≥1.1).\n* Tau positivity: Plasma p-tau217 ≥2.5 pg\u002FmL or CSF p-tau181\u002FAβ42 ratio ≥0.02.\n* Age: 50 to 90 years of age (inclusive), with at least a primary school education. Both males and females are eligible.\n* Stable medication use: If receiving approved AD therapies (e.g., acetylcholinesterase inhibitors, GV-971, NMDA receptor antagonists), doses must remain stable for ≥12 weeks prior to baseline. Treatment-naïve participants are also eligible. All other non-AD-related permitted concomitant medications must remain stable for ≥4 weeks prior to baseline unless otherwise specified.\n* Hachinski Ischemia Scale (HIS) total score ≤4.\n* Geriatric Depression Scale-15 (GDS-15) total score ≤4.\n* Neuroimaging evidence: Screening CT\u002FMRI showing age-related brain changes or cerebral atrophy.\n* Caregiver availability: Participant has a stable and reliable caregiver, as confirmed by the investigator.\n* Informed consent: Written informed consent must be provided by the participant or, if the participant lacks decision-making capacity, by a legally authorized representative (in accordance with local laws, regulations, and customs). Participants agree to provide peripheral blood, stool, and urine samples during the study for biomarker analysis.\n\nExclusion Criteria:\n\n* Diagnosis of dementia other than Alzheimer's disease (AD) or other central nervous system disorders.\n* Unstable vital signs accompanied by abnormalities in cardiac, pulmonary, hepatic, renal, or other organ functions.\n* Abnormally low folate and\u002For vitamin B12 levels, or evidence that hypothyroidism has caused or exacerbated the participant's dementia. Participants with abnormal syphilis test results.\n* Patients with comorbid psychiatric disorders.\n* Long-term alcoholism or substance abuse that may compromise the evaluation of treatment efficacy.\n* Participants with intolerance or allergy to the study medications.\n* Abnormalities detected on cranial MRI, including ischemic or hemorrhagic infarctions, hydrocephalus, or brain tumors.\n* Diagnosis of clinically significant cardiovascular or cerebrovascular disease requiring treatment within 12 months or at present.\n* Antibiotic use:\n\n  1. Continuous antibiotic use for more than 10 days within 12 weeks prior to baseline.\n  2. Anticipated need for antibiotic treatment exceeding 10 days during the study.\n* Geriatric Depression Scale-15 (GDS-15) score \\>4 at screening.\n* Any other inadequately controlled condition (e.g., cardiac, respiratory, renal, or gastrointestinal disorders affecting absorption, such as gastric cancer, gastric bypass surgery, or recurrent diarrhea) that may jeopardize participant safety or interfere with study assessments, as judged by the investigator.\n* Participation in any clinical trial involving novel chemical entities for Alzheimer's disease (AD) within 6 months prior to screening, unless confirmed to have been in the placebo group.\n* Clinically significant abnormalities in physical examination, vital signs, laboratory tests, or electrocardiogram (ECG) requiring further investigation, treatment, or posing risks to study procedures\u002Fsafety.\n* Participation in clinical trials involving therapeutic monoclonal antibodies, antibody-derived proteins, immunoglobulin therapy, or vaccines within 6 months prior to screening, unless confirmed to have been in the placebo group.\n* Participation in clinical trials involving anti-amyloid therapies (including monoclonal antibodies or BACE inhibitors), unless confirmed to have received only placebo.\n* Uncontrolled immune disorders requiring treatment with immunoglobulins, systemic monoclonal antibodies (or derivatives), systemic immunosuppressants, or plasmapheresis during the study.\n* Participants with uncontrolled bleeding disorders, including platelet count \\\u003C50,000 or INR \\>1.5 (for those not on anticoagulants, e.g., warfarin). Participants on anticoagulants must have optimized and stable dosing for ≥4 weeks prior to screening. Anticoagulated participants are excluded from cerebrospinal fluid (CSF) assessments.",{"count":58,"type":21},300,[24],"The purpose of this clinical trial is to determine whether silkworm pupa powder is effective in treating Alzheimer's disease. It will also investigate whether silkworm pupa powder can improve the nutritional and frailty status of patients with Dementia. The main questions it aims to answer are:\n\n* Will silkworm pupa powder improve the daily living conditions of patients with Alzheimer's disease?\n* Will silkworm pupa powder improve the nutritional status and frailty of Alzheimer's disease patients?\n\nResearchers will compare silkworm pupa powder with a placebo (a similar substance containing 0.5% silkworm pupa powder) to see if silkworm pupa powder can treat Alzheimer's disease.\n\nParticipants will:\n\n* Take silkworm pupa powder or placebo daily for four months;\n* Visit the clinic for check-ups and tests every four weeks;\n* Record their symptoms and various physiological indicators.",[62,28,29],"Alzheimer Disease(AD)",[27,28,64,65,66],"asthenia","nutritional status","frailty state","RECRUITING",{"date":69,"type":41},"2026-06-08",{"date":71,"type":41},"2025-04-10",{"date":45,"type":21},{"name":47,"class":48},""]