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.
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/Lecanemab or Kisunla/Donanemab) for at least 6 months prior to the infusion visit.
MMSE score 20-26.
Patients must be able to consent.
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
Single group
human Mesenchymal Stem Cells
Biological/VaccinePatients eligible to participate will receive one infusion of 25 million cells administered intravenously.
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.
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.
Click on the lead sponsor to view all of their trials.
Bernard (Barry) Baumel
Lead sponsor
University of Miami
Sponsor institution
