Could one stem cell infusion slow Alzheimer's decline?
NCT ID NCT07512362
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding a single infusion of human stem cells to standard antibody therapy can slow memory and thinking decline in people with mild Alzheimer's or mild cognitive impairment. Ten participants aged 55-90 who are already on antibody treatment will receive one stem cell infusion. The goal is to see if this combination stabilizes cognitive function better than antibodies alone.
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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 10 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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Jun 2028
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 * Patients diagnosed with Mild Cognitive Impairment or mild Dementia due to Alzheimer disease, receiving treatment with an FDA approved monoclonal antibody (Leqembi/Lecanemab or Kisunla/Donanemab) for at least 6 months prior to the infusion visit. * MMSE score 20-26. * Patients must be able to consent. * Have a family member or friend (study partner) who has frequent and sufficient contact with the patient and is able to answer questions about the participant's daily activities to complete the ADCS-MCI-ADL. Completing this scale is required to assess the impact of the study intervention on cognitive function and daily living skills in this patient population. Having a study partner is a requirement of this study. Exclusion Criteria: * Dementia other than AD * Patient with severe depression. Patients with controlled depression are allowed to participate. * Inability to independently provide informed consent is considered exclusionary per protocol requirements * Recent history of substance abuse * History of bleeding disorders, HIV, HCV or HBV * 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 MI 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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