RecruitingPhase 2NCT06781333

Human Mesenchymal Stem Cells (hMSC) in Behavioral Problems Due to Alzheimer's Disease.

A Pilot Study to Assess the Effect of Adding 1 Infusion of Human Mesenchymal Stem Cells (hMSC) to the Treatment of Patients Suffering Agitation/Aggression or Other Behavioral Abnormalities From Alzheimer's Disease.


Sponsor

Bernard (Barry) Baumel

Enrollment

8 participants

Start Date

Apr 29, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this research study is to test if adding one infusion of mesenchymal stem cells to the current treatment with antipsychotic medication may help control behavioral problems in people with a diagnosis of moderate to severe Alzheimer's disease.


Eligibility

Min Age: 55 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether infusions of human mesenchymal stem cells (a type of cell that can calm inflammation) can reduce difficult behavioral symptoms in people with Alzheimer's disease, such as agitation, aggression, hallucinations, and anxiety. **You may be eligible if...** - You are between 55 and 90 years old - You have a confirmed diagnosis of Alzheimer's disease - You have behavioral symptoms such as agitation, hallucinations, depression, anxiety, or sleep disturbances lasting at least 4 weeks - You have been taking antipsychotic medication for at least 4 weeks - A family member or trusted person is available to assist with the study **You may NOT be eligible if...** - You do not have behavioral symptoms related to Alzheimer's - You are unable to consent and have no legally authorized representative Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALhMSC

Participants will come in person to receive one intravenous infusion of approximately 25 million cells up to 20 minutes.


Locations(1)

University of Miami Department of Neurology

Miami, Florida, United States

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NCT06781333


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