Could stem cells tame Alzheimer's agitation? new pilot study seeks answers
NCT ID NCT06781333
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This small pilot study is testing whether a single infusion of human mesenchymal stem cells can help control agitation, aggression, and other behavioral symptoms in people with moderate to severe Alzheimer's disease. The study involves 8 adults aged 55-90 who are already taking antipsychotic medication. The goal is to see if the stem cell treatment can reduce these difficult behaviors and possibly lower the need for antipsychotic drugs.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 8 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2025
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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55 to 90 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Miami Department of Neurology
RECRUITINGMiami, Florida, 33136, United States
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