Using stem cells to help manage behavioral problems in Alzheimer's patients
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.
This study is testing whether adding stem cells to antipsychotic medication can help older adults with Alzheimer's who have behavioral problems feel better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 8 (estimated) |
| Ages | 55 Years to 90 Years |
| Sex | All |
| Sponsor | University of Miami Academic / other |
| Locations | 1 site (Miami, Florida) |
| Trial ID | NCT06781333 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of a single infusion of human mesenchymal stem cells (hMSC) in conjunction with antipsychotic medication for controlling behavioral issues in individuals diagnosed with moderate to severe Alzheimer's disease. Participants will be adults aged 55-90 who have been experiencing behavioral symptoms related to Alzheimer's for at least four weeks and have been on antipsychotic treatment for the same duration. The study will assess whether the addition of hMSC can improve behavioral outcomes compared to standard treatment alone.
Who should consider this trial
Good fit: Ideal candidates are adults aged 55-90 with a diagnosis of moderate to severe Alzheimer's disease and significant behavioral symptoms.
Not a fit: Patients with mild Alzheimer's disease or those not experiencing behavioral symptoms may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new therapeutic option for managing challenging behavioral symptoms in Alzheimer's patients.
How similar studies have performed: While the use of stem cells in treating Alzheimer's is an emerging field, similar studies have shown promise in addressing behavioral symptoms, though this specific approach is still under investigation.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Miami, Florida
- University of Miami Department of Neurology — Miami, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Bernard Baumel, MD — University of Miami
- Study coordinator: Bernard Baumel, MD
- Email: mep980@miami.edu
- Phone: (305) 243-3100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.