RecruitingPhase 2

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

United States8 participantsStarted 2025-04-29

Plain-language 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.

Who can participate

Age range

55 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adults 55-90 years at the time of signing consent * A diagnosis of probable Alzheimer disease (AD), defined by the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria * Previous computed tomography or magnetic resonance imaging scan of the brain with findings consistent with a diagnosis of Alzheimer disease * A diagnosis of behavioral symptoms that include any of the following: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, aberrant motor behavior, sleep and nighttime behavior disorders and appetite and eating disorders * Onset of behavioral symptoms at least 4 weeks prior to screening. * Treatment with antipsychotic medication for at least 4 weeks prior to the hMSC infusion. * Patients unable to consent should have a Legally Authorized Representative or Proxy to provide consent on their behalf. * Have a family member or friend (study partner) who has frequent and sufficient contact with the patient and able to answer questions about the participant's behavior. Exclusion Criteria: * Dementia other than AD * Patient with severe depression. Patient with controlled depression is allowed to participate. * Recent history of substance abuse * History of bleeding disorders, HIV, Hepatitis C Virus or Hepatitis B Virus * Recent history (within 3 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Neuropsychiatric Inventory

Timeframe: Up to 12 weeks.

Trial details

NCT IDNCT06781333

SponsorBernard (Barry) Baumel

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-15

Contact for this trial

Bernard Baumel, MD

(305) 243-3100 mep980@miami.edu

View on ClinicalTrials.gov More Alzheimer Disease trials

Who can participate

Age range

55 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.