Human Mesenchymal Stem Cells (hMSC) in Behavioral Problems Due to Alzheimer's Disease.
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age55-90
SponsorBernard (Barry) Baumel
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- hMSC
Treatment groups
8 Participants
are divided into 1 treatment groupSponsors and collaborators
Bernard (Barry) Baumel
Lead sponsor
University of Miami
Sponsor institution
Source ClinicalTrials.gov