ClinicalTrials.gg
RecruitingNCT06781333Updated May 28, 2026

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

A Phase 2 interventional study of hMSC in Alzheimer Disease and Agitation in Dementia, sponsored by Bernard (Barry) Baumel. Recruiting at 1 site in United States. Open to participants aged 55 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-05-28.

Sponsored by Bernard (Barry) Baumel · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Apr 2025; still recruiting 1 year 6 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
8
Allocation
Not applicable
Ages
55 Years to 90 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Alzheimer Disease
  • Agitation in Dementia

Keywords

  • aggression
  • behavior
  • agitation
03

In context

Alzheimer Disease

3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.

This study's planned enrollment of 8 is below the median of 70 across 3,019 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Bernard (Barry) Baumel is the lead sponsor of 3 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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, , Virus or Virus
  • Recent history (within 3 years) of , 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
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
8 participants (estimated)

Study arms

  • Experimental
    hMSC group

    Participants in this group will receive one infusion of hMSC. Total participation is up to 12 weeks.

    Biological: hMSC

Interventions

  • BiologicalhMSC

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

06

What researchers measure

Primary outcomes

  1. Neuropsychiatric Inventory

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

    Time frame: Up to 12 weeks.

Secondary outcomes

  1. Change in antipsychotic medications dosage

    Will be measured in milligrams

    Time frame: Baseline to 12 weeks

  2. Change in number of antipsychotic medications

    Will be measured in number of antipsychotic medications

    Time frame: Baseline to 12 weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06781333
Lead sponsor
Bernard (Barry) Baumel
Responsible party
Bernard (Barry) Baumel (Associate Professor of Neurology, University of Miami) — Sponsor-investigator
First posted
Jan 17, 2025
Start date
Apr 29, 2025
Primary completion
Dec 15, 2027 (estimated)
Completion
Dec 15, 2027 (estimated)
Last update
May 28, 2026

Study contacts

Bernard Baumel, MD
Contact
mep980@miami.edu
(305) 243-3100
Bernard Baumel, MD
principal investigator · University of Miami

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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