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RecruitingPhase 2

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

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.

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
55 Years to 90 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Infusions

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether one infusion of mesenchymal stem cells, given through a vein, can help control behavior problems. It is for people with moderate to severe Alzheimer's disease who are taking antipsychotic medicine to help manage these problems.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 55 to 90 years old when signing the consent form.
  • Have a diagnosis of likely Alzheimer's disease based on the study's medical standards.
  • Have a past CT or MRI brain scan that supports the Alzheimer's diagnosis.
  • Have behavior or mood problems, such as false beliefs, seeing or hearing things that are not there, aggression, sadness, worry, unusual excitement, lack of interest, acting without restraint, irritability, unusual movements, or sleep or eating problems.
  • Have had these behavior problems for at least 4 weeks before screening.
  • Take antipsychotic medicine for at least 4 weeks before the stem cell infusion.
  • If unable to give consent, have someone legally allowed to give consent for you.
  • Have a family member or friend who sees you often enough to answer questions about your behavior.

Who can't join

  • Have dementia other than Alzheimer's disease or severe depression. Controlled depression is allowed.
  • Have a recent history of drug or alcohol abuse.
  • Have a history of a bleeding disorder, HIV, hepatitis B, or hepatitis C.
  • Have had cancer within the past 3 years, except treated basal cell or squamous cell skin cancer, or treated melanoma, prostate cancer, or cervical cancer that has not spread beyond where it started.
  • Have uncontrolled health problems, such as high blood pressure, diabetes, unstable chest pain, or a heart attack within 1 year before screening.
  • Use an experimental Alzheimer's treatment now or within 4 weeks before screening, or have joined a clinical trial in the past 3 months.
  • Have received a transplant, or have another active health problem that the study doctor thinks could make participation unsafe or prevent you from following or finishing the study.
  • Have not yet gone through menopause.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (1)

FL