[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100580650":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":29,"locations":26,"responsibleParty":35,"collaborators":26,"id":39,"slug":40,"hasResults":41,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":26,"eligibilityCriteria":45,"healthyVolunteers":41,"sex":46,"minAge":47,"maxAge":48,"enrollmentInfo":49,"targetDuration":26,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":60,"whyStopped":26,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":26},{"fullName":5,"class":6},"Tabriz University of Medical Sciences","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention","EXPERIMENTAL","will receive 1000 mg of sodium pentaborate pentahydrate daily along with donepezil",[13],"Drug: Sodium Pentaborate Pentahydrate",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","will receive a placebo along with donepezil",[19],"Drug: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Sodium Pentaborate Pentahydrate","will receive 1000 mg of sodium pentaborate pentahydrate daily along with donepezil.",[9],null,{"type":22,"name":15,"description":17,"armGroupLabels":28,"otherNames":26},[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":26,"email":34},"Saeid Safiri, PhD","CONTACT","00989141005277","saeidsafiri@gmail.com",{"type":36,"investigatorFullName":37,"investigatorTitle":38,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Dr. Saeid Safiri","Dr","100580650","phase-2-the-safety-and-efficacy-of-sodium-pentaborate-pentahydrate-in-patients-with-mild-to-moderate-alzheimers-disease-100580650",false,"NCT06840054","The Safety and Efficacy of Sodium Pentaborate Pentahydrate in Patients With Mild to Moderate Alzheimer's Disease","The Safety and Efficacy of Sodium Pentaborate Pentahydrate in Patients With Mild to Moderate Alzheimer's Disease: A Randomised, Double-Blind, Placebo-Controlled Phase 2 Trial","Inclusion Criteria:\n\nAge between 55 and 85 years Diagnosis of mild to moderate Alzheimer's disease based on the National Institute on Aging and Alzheimer's Association (NIA-AA) criteria Mini-Mental State Examination (MMSE) score between 10 and 24 Evidence of episodic memory impairment (≥1 standard deviation below age norm) Use of stable doses of Alzheimer's medications\n\nExclusion Criteria:\n\nPresence of major neurological or psychiatric disorders Significant amyloid-related imaging abnormalities (ARIA) detected on magnetic resonance imaging (MRI) Recent use of experimental drugs","ALL","55 Years","85 Years",{"count":50,"type":51},30,"ESTIMATED","INTERVENTIONAL",[54],"PHASE2","Alzheimer's disease (AD) is the leading cause of dementia, affecting millions worldwide. With its global prevalence steadily increasing, particularly in low- and middle-income countries, the demand for effective treatments has become critical. Despite significant advancements in understanding AD pathophysiology, including amyloid-beta plaques and tau tangles, no disease-modifying therapies are currently available, highlighting the urgent need for novel therapeutic interventions.\n\nThis proposal presents a Phase 2, randomised, double-blind, placebo-controlled trial to assess the safety and efficacy of sodium pentaborate pentahydrate (NaB) in patients with mild to moderate AD. A total of 60 participants aged 55 to 85 years with confirmed AD will be randomly assigned to receive either NaB (1000 mg) or a placebo, alongside Donepezil, for six months. The primary outcome will be changes in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog13), while secondary outcomes will include the Clinical Dementia Rating-Sum of Boxes (CDR-SB) and the Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL).",[57],"Alzheimer Disease",[57,59],"Clinical Trial","NOT_YET_RECRUITING","2025-02-17",{"date":63,"type":64},"2025-02-21","ACTUAL",{"date":66,"type":51},"2025-05-01",{"date":68,"type":51},"2026-01-30",{"name":5,"class":6}]