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RecruitingPhase 2

Human Mesenchymal Stem Cells & Monoclonal Antibodies in the Treatment for Mild Cognitive Impairment or Early Alzheimer's Disease.

A Pilot Study to Assess the Effect of Adding 1 Infusion of Human Mesenchymal Stem Cells (hMSC) to Patients Treated With Anti-Amyloid Monoclonal Antibodies Who Are Suffering From Mild Cognitive Impairment or Mild 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 study is to test if adding one infusion of (Human Mesenchymal Stem Cells) hMSCs to the treatment with standard of care (SOC) monoclonal antibodies (mAb) will stabilize the rate of cognitive and functional decline associated with mild 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 adding one dose of human mesenchymal stem cells, given through a vein, to standard antibody treatment can help keep memory, thinking, and daily skills from getting worse. It is for adults ages 55–90 with mild thinking problems or mild dementia due to Alzheimer's disease who already receive antibody treatment.

The purpose of this study is to test if adding one infusion of (Human Mesenchymal Stem Cells) hMSCs to the treatment with standard of care (SOC) monoclonal antibodies (mAb) will stabilize the rate of cognitive and functional decline associated with mild 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 55–90 years old when signing the consent form.
  • Have mild cognitive impairment (mild thinking or memory problems) or mild dementia due to Alzheimer's disease.
  • Have received Leqembi (lecanemab) or Kisunla (donanemab), FDA-approved antibody medicines, for at least 6 months before the stem cell dose.
  • Have a score of 20–26 on the MMSE, a test of memory and thinking.
  • Be able to understand the study and give your own consent to join.
  • Have a family member or friend who has frequent contact with you and can answer required questions about your daily activities.

Who can't join

  • Have dementia caused by something other than Alzheimer's disease, severe depression, or a recent history of substance abuse. Controlled depression is allowed.
  • Be unable to give your own informed consent.
  • Have a history of a bleeding disorder, HIV, hepatitis C, or hepatitis B.
  • Have had cancer within the past 3 years, except treated basal cell or squamous cell skin cancer, or melanoma, prostate, or cervical cancer that stayed where it started (in situ).
  • Have uncontrolled medical problems, such as high blood pressure or diabetes, unstable angina (chest pain), or a heart attack within the year before screening.
  • Be receiving an experimental Alzheimer's treatment now or within 4 weeks before screening, or have been enrolled in 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 * 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

Study sites (1)

FL