Study of One Infusion of Human Mesenchymal Stem Cells Added to Monoclonal Antibody Treatment for Mild Cognitive Impairment or Early Alzheimers Disease in Adults Aged 55 to 90

What this Trial Is About

Researchers are evaluating whether adding a single infusion of human mesenchymal stem cells hMSCs to the standard treatment with FDA-approved monoclonal antibodies can stabilize cognitive and functional decline in adults aged 55 to 90 with mild cognitive impairment or early Alzheimers disease. This Phase 2 study focuses on patients already receiving monoclonal antibody therapy for at least six months. The main goal is to observe changes in cognitive function and daily living abilities over time. Participants will receive one intravenous infusion of 25 million human mesenchymal stem cells in addition to their ongoing monoclonal antibody treatment. The study does not include a control or placebo group, and there is no masking or blinding. The intervention is followed by assessments at baseline and at 16, 32, and 48 weeks to monitor changes in cognitive and daily functioning. Throughout the study, participants will undergo evaluations using the Alzheimers Disease Scale-Cognitive Subscale ADAS-Cog and the Alzheimers Disease Cooperative Study Activities of Daily Living Inventory for Mild Cognitive Impairment ADCS-MCI-ADL. These assessments will be conducted at multiple time points to track progress. Participants must have a study partner who can report on daily activities, and safety monitoring will continue through the study duration, which lasts nearly one year from the first infusion.

Human Mesenchymal Stem Cells & Monoclonal Antibodies in the Treatment for Mild Cognitive Impairment or Early Alzheimer's Disease.