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Human Mesenchymal Stem Cells for Behavioral Problems in Alzheimer's Disease

This study is looking at whether adding one intravenous (into a vein) infusion of human mesenchymal stem cells (hMSC) to current antipsychotic medication can help manage behavioral problems in people with moderate to severe Alzheimer's disease. Researchers will measure changes in behavioral problems using the Neuropsychiatric Inventory up to 12 weeks after the infusion. To join, you must be between 55 and 90 years old and have a probable diagnosis of Alzheimer's disease. This study is currently unclear about its recruitment status and plans to enroll 8 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 8 participants.
What's involved
Participants will come in person to receive one intravenous infusion of approximately 25 million cells, which will take up to 20 minutes.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome, Neuropsychiatric Inventory, will be measured up to 12 weeks.

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NCT06781333

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

Recruiting
PHASE2Ages 55–90InterventionalTreatment
Bernard (Barry) Baumel
~8 participants
Updated 2026-05-28 on ClinicalTrials.gov
What's tested:hMSC

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Neuropsychiatric Inventory
Measured over Up to 12 weeks.

Conditions

Alzheimer Disease
Agitation in Dementia

Explore related trials

Alzheimer's Disease

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Bernard Baumel, MD · PRINCIPAL_INVESTIGATOR · University of Miami

Who to contact

Bernard Baumel, MD
[email protected]
(305) 243-3100
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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 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 Myocardial Infarction 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

What this trial measures

  • Neuropsychiatric InventoryUp to 12 weeks.

    Score ranges from 0-12, higher scores indicate a worse psychiatric outcome