RecruitingAlzheimer DiseaseAgitation in Dementia
Human Mesenchymal Stem Cells (hMSC) in Behavioral Problems Due to Alzheimer's Disease.
Eligible age
55–90 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
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.
Sponsor: Bernard (Barry) Baumel
You may qualify if…
- ✓ 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.
You may not qualify if…
- ✕ 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.
Where it's recruiting
Florida
Miami
Source: ClinicalTrials.gov · NCT06781333 · last updated 2026-05-28