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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age55-90
SponsorBernard (Barry) Baumel

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • human Mesenchymal Stem Cells

Treatment groups

10 Participants
are divided into 1 treatment group

Sponsors and collaborators

Bernard (Barry) Baumel

Lead sponsor

University of Miami

Sponsor institution