[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Wanbangde Pharmaceutical Group Co., LTD\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":89},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,40,65],{"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},"100605098","phase-1-bioequivalence-study-of-wp205-in-healthy-subjects-100605098",false,"NCT07158099","Bioequivalence Study of WP205 in Healthy Subjects","A Single-Center, Randomized, Open-Label, Two-Period, Two-Sequence, Single-Dose, Crossover Bioequivalence Study of Methylconalamin Injection and Methylconalamin for Injection in Healthy Subjects Under Fasting Conditions","Inclusion Criteria:\n\n1. Subjects have been fully informed of the study purpose, nature, procedures, and potential adverse reactions, voluntarily agree to participate, and have signed the informed consent form prior to any study-related procedures.\n2. Male or female subjects aged 18 years or older, with an appropriate gender distribution.\n3. Body weight: females ≥ 45.0 kg, males ≥ 50.0 kg, and body mass index (BMI) between 19.0 and 26.0 kg\u002Fm² (inclusive); BMI = weight (kg) \u002F height² (m²).\n4. Subjects are able to communicate effectively with the investigators and can understand and comply with all study requirements.\n\nExclusion Criteria:\n\n1. Known allergy to methylconalamin injection, methylconalamin injection, or any component of the formulations, or history of hypersensitivity (e.g., rash, urticaria).\n2. History of clinically significant diseases or any other medical or physiological condition that could interfere with study results, including but not limited to disorders of the hematologic, cardiovascular, digestive, urinary, respiratory, nervous, immune, or endocrine systems, malignancy, psychiatric disorders, or metabolic abnormalities.\n3. History of significant bleeding tendency, coagulation disorders, systemic bleeding, neutropenia, or thrombocytopenia.\n4. Vaccination with any vaccine or live attenuated vaccine within 1 month prior to dosing, or planned vaccination during the study.\n5. Consumption within 48 hours prior to dosing of foods or beverages that may affect metabolism (e.g., grapefruit, pomelo, mango, orange), alcohol, purine-rich or caffeine-containing foods\u002Fbeverages (e.g., coffee, strong tea, chocolate), or foods rich in vitamin B12 (e.g., animal liver such as pork, beef, chicken, and shellfish such as oysters or clams).\n6. Daily excessive consumption of tea, coffee, and\u002For caffeine-containing beverages (≥8 cups per day, 1 cup = 250 mL) within 3 months prior to screening.\n7. Use of any drugs that affect liver enzyme activity within 30 days prior to first dose (e.g., enzyme inducers such as barbiturates, carbamazepine, phenytoin, dexamethasone; inhibitors such as SSRIs, ciprofloxacin, diltiazem, macrolides, metronidazole, ketoconazole, verapamil, fluoroquinolones).\n8. Use of any medication (prescription, over-the-counter, herbal, vitamin, or dietary supplement) within 2 weeks prior to screening, except for topical medications or eye drops with local effects.\n9. Weekly alcohol consumption exceeding 14 units within 3 months prior to screening (1 unit ≈ 360 mL beer or 45 mL spirits with 40% alcohol or 150 mL wine), or positive alcohol breath test, or inability to abstain from alcohol during the study.\n10. Smoking ≥5 cigarettes\u002Fday within 3 months prior to screening, or inability to stop tobacco use during the study, or positive nicotine test.\n11. History of substance abuse within 3 months prior to screening, or positive drug screening.\n12. Blood donation or significant blood loss (≥400 mL), transfusion, or use of blood products within 3 months prior to screening, or planned blood donation during the study or within 3 months after study completion.\n13. History of surgery within 3 months prior to screening, planned surgery during the study, or history of surgery that may affect drug absorption, distribution, metabolism, or excretion.\n14. Use of any investigational drug or participation in any drug\u002Fdevice clinical trial within 3 months prior to screening.\n15. Clinically significant abnormalities in vital signs, physical examination, laboratory tests (hematology, urinalysis, blood biochemistry, coagulation), chest X-ray, or 12-lead ECG.\n16. Positive test for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), syphilis antibody (anti-TP), or HIV antibody (anti-HIV).\n17. Subjects with special dietary requirements unable to comply with standardized study diet.\n18. Subjects unable to tolerate venipuncture or with difficult venous access, or history of orthostatic hypotension, syncope, or needle phobia.\n19. Male (or their partner) or female subjects planning pregnancy, egg\u002Fsperm donation, unwilling to use effective contraception, positive pregnancy test, or lactating females from signing consent to 1 month after last dose.\n20. Subjects deemed unsuitable for participation by their own reason or at the investigator's discretion.",true,"ALL","18 Years",{"count":20,"type":21},14,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This study is a single-center, randomized, open-label, two-period, two-sequence, single-dose, crossover bioequivalence trial conducted under fasting conditions in healthy adult volunteers. Participants will be randomized into two sequences (A and B). Each participant will receive a single intramuscular dose of the test or reference formulation according to the assigned sequence, with an adequate washout period between dosing. The primary objective of the study is to evaluate the bioequivalence of the two formulations.",[27],"Therapeutic Equivalency, Healthy","NOT_YET_RECRUITING","2025-08-27",{"date":31,"type":32},"2025-09-05","ACTUAL",{"date":34,"type":21},"2025-09-15",{"date":36,"type":21},"2025-09-30",{"name":38,"class":39},"Wanbangde Pharmaceutical Group Co., LTD","INDUSTRY",{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":17,"minAge":47,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":4},"100598079","phase-2-clinical-study-to-evaluate-the-efficacy-and-safety-of-huperzine-a-controlled-release-tablets-in-patients-with-mild-to-moderate-dementia-of-the-alzheimers-type-100598079","NCT07066826","Clinical Study to Evaluate the Efficacy and Safety of Huperzine A Controlled-Release Tablets in Patients With Mild-to-Moderate Dementia of the Alzheimer's Type","A Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo- and Active-Controlled, Parallel-Group Phase II\u002FIII Clinical Study to Evaluate the Efficacy and Safety of Huperzine A Controlled-Release Tablets in Patients With Mild-to-Moderate Dementia of the Alzheimer's Type","Inclusion Criteria:\n\n1. The subject voluntarily agrees to participate in the study and signs the informed consent form jointly with a legally authorized representative (LAR). If the subject is unable to sign due to cognitive impairment or other reasons, the signature field for the subject may be left blank, with the reason specified and signed by the LAR. In such cases, the LAR must sign the informed consent form on behalf of the subject.\n2. Aged ≥50 and ≤85 years, male or female.\n3. Meets the diagnostic criteria for probable Alzheimer's disease (AD) dementia according to the 2011 National Institute on Aging and Alzheimer's Association (NIA-AA) guidelines.\n4. Has experienced memory impairment for at least 12 months, with a chronic and progressively worsening course.\n5. Has received ≥5 years of formal education and is able to complete the protocol-specified cognitive assessments.\n6. Diagnosed with Stage 4 or 5 (mild to moderate dementia) according to the Revised Clinical Staging of Alzheimer's Disease (2024) (i.e., Clinical Dementia Rating \\[CDR\\] global score of 1 or 2).\n7. Total score on the Mini-Mental State Examination (MMSE) is between 11 and 26 inclusive.\n8. Has undergone a cranial MRI scan showing a Medial Temporal Atrophy (MTA) visual rating scale grade ≥1. If the subject has completed an eligible MRI at this or another tertiary hospital within 6 months prior to screening, and it meets the protocol requirements, re-scanning is not required.\n9. Capable of undergoing positron emission tomography (PET) imaging.\n10. Hachinski Ischemic Score (HIS) ≤ 4.\n11. Hamilton Depression Rating Scale (HAMD-17) score of ≤10.\n12. No obvious focal neurological signs on physical examination, except those attributable to peripheral injury.\n13. Has a stable and reliable caregiver, or is in frequent contact with a caregiver (at least 4 days per week and ≥2 hours per day). The caregiver must accompany the subject to study visits, provide reliable information for scale assessments based on sufficient interaction and communication with the subject, and should remain the same throughout the study whenever possible.\n\nExclusion Criteria:\n\n1. Subjects who are allergic to the active ingredient or excipients of huperzine A controlled-release tablets or donepezil, or those with lactose intolerance.\n2. Cognitive impairment or dementia not caused by Alzheimer's disease (AD), including:\n\n(1) Other neurodegenerative diseases (e.g., dementia with Lewy bodies, frontotemporal degeneration, Huntington's disease, Parkinson's disease); (2) Non-degenerative neurological conditions causing cognitive impairment or dementia (e.g., vascular cognitive impairment or dementia, hydrocephalus, encephalitis, hypoxic brain injury, traumatic brain injury); (3) Non-neurological systemic diseases causing cognitive impairment or dementia (e.g., endocrine disorders such as hypothyroidism, hepatic insufficiency, hepatic encephalopathy, dialysis encephalopathy, neurosyphilis, HIV); (4) Cognitive impairment or dementia caused by vitamin deficiencies (e.g., folate or vitamin B12 deficiency).\n\n3.Subjects diagnosed, per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), with psychiatric disorders within the past 12 months that are unstable or may interfere with study assessments, including but not limited to schizophrenia or other psychotic disorders, bipolar disorder, major depressive disorder, delirium, or substance (including alcohol) use disorders with dependence.\n\n4.Subjects with significant focal brain lesions on MRI, including but not limited to any of the following (if a qualifying head MRI was performed within 6 months prior to screening and meets protocol requirements, repeat imaging is not required):\n\n1. Presence of lesions indicating large-area cerebral infarction;\n2. Infarcts in critical brain regions (e.g., thalamus, hippocampus, entorhinal cortex, parahippocampal gyrus, angular gyrus, cortical or subcortical gray matter nuclei);\n3. More than two infarcts with a diameter \\>2 cm, and deemed by the investigator to impact cognitive assessments;\n4. Multiple lacunar infarcts, deemed by the investigator to impact cognitive assessments;\n5. Severe white matter lesions;\n6. Intracerebral hemorrhage deemed likely to affect cognitive assessments by the investigator;\n7. Hydrocephalus.\n\n5.Subjects with uncontrolled seizures (and\u002For epilepsy syndromes), or those with cognitive impairment caused or potentially caused by recurrent seizures or antiepileptic drug use.\n\n6.Subjects who experienced acute cardiovascular or cerebrovascular events within 3 months prior to screening (e.g., unstable angina, second- or third-degree atrioventricular block or other serious arrhythmias, myocardial infarction, decompensated congestive heart failure of NYHA class III or IV, transient ischemic attack, or ischemic stroke).\n\n7.Subjects with uncontrolled hypertension or hypotension at screening (defined as systolic blood pressure ≥160 mmHg or \\\u003C90 mmHg, or diastolic blood pressure ≥100 mmHg or \\\u003C60 mmHg after pharmacologic or non-pharmacologic treatment); subjects with slight deviations beyond this range but deemed clinically insignificant by the investigator may be included.\n\n8.Subjects with serious active gastrointestinal disorders (e.g., severe gastroesophageal reflux, gastrointestinal bleeding, or peptic ulcers) within 3 months prior to screening, or who have undergone any surgical procedures that may affect drug absorption (e.g., total gastrectomy, total small bowel resection).\n\n9.Subjects with other uncontrolled clinical conditions (e.g., malignancies, severe infectious diseases, respiratory diseases).\n\n10.Subjects with sinus bradycardia at screening (resting heart rate \\\u003C60 bpm) that is deemed clinically significant by the investigator.\n\n11.Subjects with corrected QT interval using Fridericia's formula (QTcF) \\>450 ms in males or \\>470 ms in females at screening or baseline.\n\n12.Subjects with renal dysfunction (serum creatinine \\[Scr\\] \\>1.5× the upper limit of normal \\[ULN\\] per the study center laboratory) or hepatic dysfunction (ALT or AST \\>2× ULN).\n\n13.Subjects with thyroid function abnormalities at screening that are deemed clinically significant and unsuitable for study participation by the investigator.\n\n14.Subjects who test positive for syphilis antibodies or HIV antibodies. 15.Subjects who received donanemab within 2 months prior to screening; lecanemab within 5 weeks prior to screening; or any other medication for the treatment of AD or cognitive enhancement within 4 weeks prior to screening, including but not limited to cholinesterase inhibitors, NMDA receptor antagonists, and other nootropic agents.\n\n16.Subjects who participated in any drug clinical trial (excluding vitamins and minerals) within 1 month prior to screening or 7 half-lives of the study drug (whichever is longer), or who are currently participating in another clinical trial.\n\n17.Subjects who are unable to complete the required scale assessments due to uncorrectable vision or hearing impairments.\n\n18.Subjects who are unable to complete study-required assessments due to personal limitations, such as contraindications to MRI scanning.\n\n19.Subjects of childbearing potential (male or female) who are unwilling to use effective contraception from the start of the study until 6 months after the end of the study, and\u002For female subjects of childbearing potential who are unwilling or unable to undergo pregnancy testing.\n\n20.Pregnant or breastfeeding women. 21.Any other condition that, in the opinion of the investigator, renders the subject unsuitable for participation in the study.","50 Years","85 Years",{"count":50,"type":21},720,[52,53],"PHASE2","PHASE3","This study is a multicenter, randomized, double-blind, double-dummy, active- and placebo-controlled, parallel-group clinical trial. The dose confirmation stage is designed to evaluate the efficacy and safety of different doses of huperzine A controlled-release tablets in patients with mild-to-moderate dementia of the Alzheimer's type, with the goal of providing a basis for dose selection in the subsequent efficacy confirmation stage. The efficacy confirmation stage aims to assess the effect of huperzine A controlled-release tablets on cognitive function and functional abilities in patients with mild-to-moderate dementia of the Alzheimer's type.In the open-label extension stage, all subjects will receive huperzine A controlled-release tablets until Week 52, to further evaluate the long-term efficacy and safety of the treatment.",[56],"Alzheimer Dementia","2025-07-11",{"date":59,"type":32},"2025-07-15",{"date":61,"type":21},"2025-08-01",{"date":63,"type":21},"2028-08-15",{"name":38,"class":39},{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":71,"enrollmentInfo":72,"targetDuration":4,"studyType":22,"phases":74,"briefSummary":76,"conditions":77,"keywords":4,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},"100570214","phase-4-the-study-of-ginkgo-leaf-dropping-pills-and-huperzine-a-injection-combined-with-median-nerve-electrical-stimulation-in-the-treatment-of-cognitive-impairment-after-brain-injury-100570214","NCT06704334","The Study of Ginkgo Leaf Dropping Pills and Huperzine a Injection Combined with Median Nerve Electrical Stimulation in the Treatment of Cognitive Impairment After Brain Injury","Inclusion Criteria:\n\n* Be over 18 years old\n\n  * Residual cognitive impairment due to brain injury\n\n    * No previous history of brain-related diseases except this one\n\nExclusion Criteria:\n\n* The patient had severe underlying disease and unstable vital signs\n\n  * The patient was complicated with consciousness disorder and could not cooperate with cognitive function assessment ③ Allergic to drugs or contraindications in drug use ④ There are contraindications of median nerve electrical stimulation","80 Years",{"count":73,"type":21},50,[75],"PHASE4","This study will conduct a single-center clinical trial to explore the initial therapeutic effect of ginkgo biloba dropping pills, huperzine A injection and median nerve electrical stimulation in patients with cognitive impairment.",[78],"Cognitive Impairment After Brain Injury","RECRUITING","2024-12-05",{"date":82,"type":32},"2024-12-11",{"date":84,"type":32},"2024-04-01",{"date":86,"type":21},"2026-12-31",{"name":38,"class":39},1,""]