[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07512362":3,"trial-entities:NCT07512362":146,"trial-summary:NCT07512362":151},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":38,"secondary_outcomes":43,"sex":47,"minimum_age":48,"maximum_age":49,"healthy_volunteers":15,"eligibility_criteria":50,"std_ages":70,"locations":73,"central_contacts":92,"overall_officials":95,"references":99,"see_also_links":145},"NCT07512362","20251381","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.","RECRUITING","2028-06-15","2026-05","2026-05-28","2026-05-15","Bernard (Barry) Baumel","OTHER",false,"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.",null,[19,20,21],"Mild Cognitive Impairment","Early Alzheimer's Disease","AD-MCI",[19,23,21,20],"MCI","INTERVENTIONAL","TREATMENT",[27],"PHASE2",{"count":29,"type":30},10,"ESTIMATED",[32],{"type":33,"name":34,"description":35,"armGroupLabels":36},"BIOLOGICAL","human Mesenchymal Stem Cells","Patients eligible to participate will receive one infusion of 25 million cells administered intravenously.",[37],"Mesenchymal Stem Cell Infusion",[39],{"measure":40,"description":41,"timeFrame":42},"Change in Alzheimer's Disease Scale-Cognitive Subscale (ADAS-Cog)","The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog-11) is a validated performance-based instrument used to assess the severity of cognitive impairment in individuals with Alzheimer's disease. The scale evaluates multiple cognitive domains, including memory, reasoning, language, orientation, ideational praxis, and constructional praxis. Spoken language, language comprehension, word-finding ability, and the ability to remember instructions are also assessed. Scores range from 0 to 70, with higher scores indicating greater cognitive impairment.","Baseline, Week 16, Week 32, and Week 48",[44],{"measure":45,"description":46,"timeFrame":42},"Change in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory for Mild Cognitive Impairment (ADCS-MCI -ADL)","The Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory for Mild Cognitive Impairment (ADCS-MCI-ADL) is an 18-item caregiver-reported instrument assessing basic and instrumental daily activities. Total scores range from 0 to 57, with higher scores indicating greater functional independence.","ALL","55 Years","90 Years",{"inclusion":51,"exclusion":57,"raw_text":69},[52,53,54,55,56],"Adults 55-90 years at the time of signing consent","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.","MMSE score 20-26.","Patients must be able to consent.","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.",[58,59,60,61,62,63,64,65,66,67,68],"Dementia other than AD","Patient with severe depression. Patients with controlled depression are allowed to participate.","Inability to independently provide informed consent is considered exclusionary per protocol requirements","Recent history of substance abuse","History of bleeding disorders, HIV, HCV or HBV","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.","Uncontrolled medical conditions (hypertension, diabetes, unstable angina or MI within 1 year prior to screening)","History of bleeding disorder","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.","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","Be premenopausal","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",[71,72],"ADULT","OLDER_ADULT",[74],{"facility":75,"status":8,"city":76,"state":77,"zip":78,"country":79,"contacts":80,"geoPoint":89},"University of Miami Department of Neurology","Miami","Florida","33136","United States",[81,86],{"name":82,"role":83,"phone":84,"email":85},"Maria E. Puertas, CRC","CONTACT","(305) 243-3100","mep980@miami.edu",{"name":87,"role":88},"Bernard S Baumel, MD","PRINCIPAL_INVESTIGATOR",{"lat":90,"lon":91},25.77427,-80.19366,[93],{"name":94,"role":83,"phone":84,"email":85},"Maria E. Puertas",[96],{"name":97,"affiliation":98,"role":88},"Bernard S. Baumel, MD","University of Miami",[100,104,106,108,110,112,114,117,119,122,124,127,129,132,135,137,139,142],{"pmid":101,"type":102,"citation":103},"9236950","BACKGROUND","Galasko D, Bennett D, Sano M, Ernesto C, Thomas R, Grundman M, Ferris S. An inventory to assess activities of daily living for clinical trials in Alzheimer's disease. The Alzheimer's Disease Cooperative Study. Alzheimer Dis Assoc Disord. 1997;11 Suppl 2:S33-9.",{"type":102,"citation":105},"doi:10.1177\u002F1352458513475735",{"type":102,"citation":107},"doi:10.1016\u002FS1474-4422(15)70016-5",{"type":102,"citation":109},"doi:10.1001\u002Fjamanetworkopen.2023.45175",{"type":102,"citation":111},"doi:10.1016\u002FS1474-4422(11)70305-2",{"type":102,"citation":113},"doi:10.1212\u002FWNL.0b013e3181b6bb95",{"pmid":115,"type":102,"citation":116},"35357079","Brody M, Agronin M, Herskowitz BJ, Bookheimer SY, Small GW, Hitchinson B, Ramdas K, Wishard T, McInerney KF, Vellas B, Sierra F, Jiang Z, Mcclain-Moss L, Perez C, Fuquay A, Rodriguez S, Hare JM, Oliva AA Jr, Baumel B. Results and insights from a phase I clinical trial of Lomecel-B for Alzheimer's disease. Alzheimers Dement. 2023 Jan;19(1):261-273. doi: 10.1002\u002Falz.12651. Epub 2022 Mar 31.",{"type":102,"citation":118},"Alzheimer's Association 2024 Alzheimer's Disease Facts and Figures",{"pmid":120,"type":102,"citation":121},"31652984","Guadix JA, Lopez-Beas J, Clares B, Soriano-Ruiz JL, Zugaza JL, Galvez-Martin P. Principal Criteria for Evaluating the Quality, Safety and Efficacy of hMSC-Based Products in Clinical Practice: Current Approaches and Challenges. Pharmaceutics. 2019 Oct 24;11(11):552. doi: 10.3390\u002Fpharmaceutics11110552.",{"type":102,"citation":123},"doi: 10.3390\u002Fpharmaceutics11110552",{"pmid":125,"type":102,"citation":126},"33353235","Salari V, Mengoni F, Del Gallo F, Bertini G, Fabene PF. The Anti-Inflammatory Properties of Mesenchymal Stem Cells in Epilepsy: Possible Treatments and Future Perspectives. Int J Mol Sci. 2020 Dec 18;21(24):9683. doi: 10.3390\u002Fijms21249683.",{"type":102,"citation":128},"doi:10.1038\u002Fni.3102.",{"pmid":130,"type":102,"citation":131},"37213538","Qiao Y, Chi Y, Zhang Q, Ma Y. Safety and efficacy of lecanemab for Alzheimer's disease: a systematic review and meta-analysis of randomized clinical trials. Front Aging Neurosci. 2023 May 5;15:1169499. doi: 10.3389\u002Ffnagi.2023.1169499. eCollection 2023.",{"pmid":133,"type":102,"citation":134},"16437532","Birks J. Cholinesterase inhibitors for Alzheimer's disease. Cochrane Database Syst Rev. 2006 Jan 25;2006(1):CD005593. doi: 10.1002\u002F14651858.CD005593.",{"type":102,"citation":136},"Staff, BrightFocus Editorial. \"5 Things to Know about the New Alzheimer's Drug, KISUNLA.\" BrightFocus Foundation, 23 Jan. 2025, www.brightfocus.org\u002Fresource\u002Falzheimers-article-5-things-know-about-new-alzheimers-drug-kisunla\u002F.",{"type":102,"citation":138},"doi:10.1001\u002Fjama.2023.25768",{"pmid":140,"type":102,"citation":141},"34567426","Skok M. Mesenchymal stem cells as a potential therapeutic tool to cure cognitive impairment caused by neuroinflammation. World J Stem Cells. 2021 Aug 26;13(8):1072-1083. doi: 10.4252\u002Fwjsc.v13.i8.1072.",{"pmid":143,"type":102,"citation":144},"6496779","Rosen WG, Mohs RC, Davis KL. A new rating scale for Alzheimer's disease. Am J Psychiatry. 1984 Nov;141(11):1356-64. doi: 10.1176\u002Fajp.141.11.1356.",[],{"nct_id":4,"conditions":147,"biomarkers":150},[148,149],"Alzheimer's Disease","Mild cognitive disorder",[],{"nct_id":4,"found":152,"summary":153,"prompt_version":17},true,{"design":154,"status":155,"heading":156,"summary":157,"follow_up":158,"word_count":159,"commitments":160,"compensation":161,"drugs_mentioned":162},"This is an interventional study. It plans to enroll 10 participants.","completed","Human Mesenchymal Stem Cells & Monoclonal Antibodies for Mild Cognitive Impairment or Early Alzheimer's Disease","This study is looking at whether adding a single infusion of human Mesenchymal Stem Cells (hMSCs) can help stabilize memory and thinking decline in people with mild cognitive impairment or early Alzheimer's disease. You would need to be between 55 and 90 years old and already receiving treatment with an FDA-approved monoclonal antibody like Leqembi (lecanemab) or Kisunla (donanemab) for at least six months. The study will measure changes in your cognitive (thinking and memory) abilities using a test called ADAS-Cog over 48 weeks to see if the hMSCs help. The current status of this study is unclear, and it plans to enroll 10 participants.","Participants will be followed for 48 weeks after the infusion.",105,"You would receive one intravenous infusion of 25 million human Mesenchymal Stem Cells. Your cognitive abilities would be measured at baseline, week 16, week 32, and week 48.","Not stated in the trial record.",[34]]