Agitation in Dementia, Alzheimer Disease
Conditions
Keywords
aggression, behavior, agitation
Brief 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.
Interventions
BIOLOGICALhMSC
Participants will come in person to receive one intravenous infusion of approximately 25 million cells up to 20 minutes.
Sponsors
Bernard (Barry) Baumel
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to 90 Years
Healthy volunteers
No
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neuropsychiatric Inventory | Up to 12 weeks. | Score ranges from 0-12, higher scores indicate a worse psychiatric outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in antipsychotic medications dosage | Baseline to 12 weeks | Will be measured in milligrams |
| Change in number of antipsychotic medications | Baseline to 12 weeks | Will be measured in number of antipsychotic medications |
Countries
United States
Contacts
CONTACTBernard Baumel, MD
PRINCIPAL_INVESTIGATORBernard Baumel, MD
University of Miami
Outcome results
None listed