Health TrialsbyHealthPanel

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

ConditionsAlzheimer DiseaseAgitation in Dementia
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • hMSC

    Biological/Vaccine

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

Treatment groups

8 Participants
are divided into 1 treatment group
Group A: hMSC groupExperimental treatment 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bernard (Barry) Baumel

Lead sponsor

University of Miami

Sponsor institution

Source ClinicalTrials.gov
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