NCT07512362 · Phase 2 · RECRUITING
Human Mesenchymal Stem Cells & Monoclonal Antibodies in the Treatment for Mild Cognitive Impairment or Early Alzheimer's Disease.
This Phase 2 trial is testing whether a single infusion of human mesenchymal stem cells, added on top of an already-approved anti-amyloid drug (lecanemab or donanemab), can slow cognitive and functional decline in people with mild cognitive impairment or early Alzheimer's. Phase 2 means researchers are still gathering evidence on whether this combination works and is safe — it is not a proven or approved treatment.
You may qualify if
- 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.
- 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.
You're excluded if
- 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
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-05-28