[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Bernard (Barry) Baumel\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":69},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"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":30,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100632336","phase-2-human-mesenchymal-stem-cells--monoclonal-antibodies-in-the-treatment-for-mild-cognitive-impairment-or-early-alzheimers-disease-100632336",false,"NCT07512362","Human Mesenchymal Stem Cells & Monoclonal Antibodies in the Treatment for Mild Cognitive Impairment or Early Alzheimer's Disease.","A Pilot Study to Assess the Effect of Adding 1 Infusion of Human Mesenchymal Stem Cells (hMSC) to Patients Treated With Anti-Amyloid Monoclonal Antibodies Who Are Suffering From Mild Cognitive Impairment or Mild Alzheimer's Disease.","Inclusion Criteria:\n\n* Adults 55-90 years at the time of signing consent\n* Patients diagnosed with Mild Cognitive Impairment or mild Dementia due to Alzheimer disease, receiving treatment with an FDA approved monoclonal antibody (Leqembi\u002FLecanemab or Kisunla\u002FDonanemab) for at least 6 months prior to the infusion visit.\n* MMSE score 20-26.\n* Patients must be able to consent.\n* Have a family member or friend (study partner) who has frequent and sufficient contact with the patient and is able to answer questions about the participant's daily activities to complete the ADCS-MCI-ADL. Completing this scale is required to assess the impact of the study intervention on cognitive function and daily living skills in this patient population. Having a study partner is a requirement of this study.\n\nExclusion Criteria:\n\n* Dementia other than AD\n* Patient with severe depression. Patients with controlled depression are allowed to participate.\n* Inability to independently provide informed consent is considered exclusionary per protocol requirements\n* Recent history of substance abuse\n* History of bleeding disorders, HIV, HCV or HBV\n* Recent history (within 3 years) of malignancies, except for treated basal cell, squamous carcinoma or melanoma in situ, prostate in situ, cervical carcinoma in situ.\n* Uncontrolled medical conditions (hypertension, diabetes, unstable angina or MI within 1 year prior to screening)\n* History of bleeding disorder\n* Currently receiving (or received within four weeks of screening) experimental agents for the treatment of Alzheimer's Disease or enrolled in clinical trials in the prior 3 months.\n* Be a transplant recipient or in any other active medical condition than in the opinion of the investigator may compromise the safety or compliance of the patient or preclude successful completion of the study\n* Be premenopausal","ALL","55 Years","90 Years",{"count":20,"type":21},10,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The purpose of this study is to test if adding one infusion of (Human Mesenchymal Stem Cells) hMSCs to the treatment with standard of care (SOC) monoclonal antibodies (mAb) will stabilize the rate of cognitive and functional decline associated with mild Alzheimer's Disease.",[27,28,29],"Mild Cognitive Impairment","Early Alzheimer's Disease","AD-MCI",[27,31,29,28],"MCI","RECRUITING","2026-05-26",{"date":35,"type":36},"2026-05-28","ACTUAL",{"date":38,"type":36},"2026-05-15",{"date":40,"type":21},"2028-06-15",{"name":42,"class":43},"Bernard (Barry) Baumel","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":55,"conditions":56,"keywords":59,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":63,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":44},"100576133","phase-2-human-mesenchymal-stem-cells-hmsc-in-behavioral-problems-due-to-alzheimers-disease-100576133","NCT06781333","Human Mesenchymal Stem Cells (hMSC) in Behavioral Problems Due to Alzheimer's Disease.","A Pilot Study to Assess the Effect of Adding 1 Infusion of Human Mesenchymal Stem Cells (hMSC) to the Treatment of Patients Suffering Agitation\u002FAggression or Other Behavioral Abnormalities From Alzheimer's Disease.","Inclusion Criteria:\n\n* Adults 55-90 years at the time of signing consent\n* A diagnosis of probable Alzheimer disease (AD), defined by the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria\n* Previous computed tomography or magnetic resonance imaging scan of the brain with findings consistent with a diagnosis of Alzheimer disease\n* A diagnosis of behavioral symptoms that include any of the following: delusions, hallucinations, agitation\u002Faggression, depression\u002Fdysphoria, anxiety, elation\u002Feuphoria, apathy\u002Findifference, disinhibition, irritability\u002Flability, aberrant motor behavior, sleep and nighttime behavior disorders and appetite and eating disorders\n* Onset of behavioral symptoms at least 4 weeks prior to screening.\n* Treatment with antipsychotic medication for at least 4 weeks prior to the hMSC infusion.\n* Patients unable to consent should have a Legally Authorized Representative or Proxy to provide consent on their behalf.\n* Have a family member or friend (study partner) who has frequent and sufficient contact with the patient and able to answer questions about the participant's behavior.\n\nExclusion Criteria:\n\n* Dementia other than AD\n* Patient with severe depression. Patient with controlled depression is allowed to participate.\n* Recent history of substance abuse\n* History of bleeding disorders, HIV, Hepatitis C Virus or Hepatitis B Virus\n* Recent history (within 3 years) of malignancies, except for treated basal cell, squamous carcinoma or melanoma in situ, prostate in situ, cervical carcinoma in situ.\n* Uncontrolled medical conditions (hypertension, diabetes, unstable angina or Myocardial Infarction within 1 year prior to screening)\n* History of bleeding disorder\n* Currently receiving (or received within four weeks of screening) experimental agents for the treatment of Alzheimer's Disease or enrolled in clinical trials in the prior 3 months.\n* Be a transplant recipient or in any other active medical condition than in the opinion of the investigator may compromise the safety or compliance of the patient or preclude successful completion of the study\n* Be premenopausal",{"count":53,"type":21},8,[24],"The purpose of this research study is to test if adding one infusion of mesenchymal stem cells to the current treatment with antipsychotic medication may help control behavioral problems in people with a diagnosis of moderate to severe Alzheimer's disease.",[57,58],"Alzheimer Disease","Agitation in Dementia",[60,61,62],"aggression","behavior","agitation",{"date":35,"type":36},{"date":65,"type":36},"2025-04-29",{"date":67,"type":21},"2027-12-15",{"name":42,"class":43},""]