Alzheimer DiseasePhase 2NCT06781333
Human Mesenchymal Stem Cells (hMSC) in Behavioral Problems Due to Alzheimer's Disease.
A Phase 2 study testing hMSC in people with Alzheimer Disease and Agitation in Dementia, run by Bernard (Barry) Baumel at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 90 years
- Conditions the study is for
- Alzheimer Disease, Agitation in Dementia
- What is being tested?
- hMSC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Apr 2025to 15 Dec 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Miami Department of Neurology
Miami, Florida, 33136
Maria E. Puertas, (305) 243-0184, mep980@miami.edu
Carmen Perez, (305) 243-0184, c.perez71@miami.edu
About this study
Official title: 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.
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.
- Conditions
- Alzheimer Disease, Agitation in Dementia
- Being tested
- hMSC
- Keywords
- aggression, behavior, agitation
- Medical subject headings
- Alzheimer Disease, Aberrant Motor Behavior in Dementia, Aggression, Behavior, Psychomotor Agitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hMSCBiological
Participants will come in person to receive one intravenous infusion of approximately 25 million cells up to 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| hMSC group | Experimental | Participants in this group will receive one infusion of hMSC. Total participation is up to 12 weeks. Receives: Biological: hMSC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropsychiatric Inventory
Score ranges from 0-12, higher scores indicate a worse psychiatric outcome
Measured: Up to 12 weeks.
Secondary outcomes (2)
Change in antipsychotic medications dosage
Will be measured in milligrams
Measured: Baseline to 12 weeks
Change in number of antipsychotic medications
Will be measured in number of antipsychotic medications
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start29 Apr 2025
- Primary completion15 Dec 2027 (estimated)
- Study completion15 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bernard (Barry) Baumel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bernard (Barry) Baumel, University of Miami
- Investigators
- Bernard Baumel, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06781333
- Sponsor's protocol ID
- 20240984
- Status last verified
- May 2026
- First submitted
- 13 Jan 2025
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No