No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
55 – 90
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
10 (estimated)
Sponsor
Bernard (Barry) Baumel · Other
Who this trial is looking for
This trial is looking for adults with mild cognitive impairment or early Alzheimer's disease. Participants will receive a one-time infusion of human stem cells along with their usual treatment of monoclonal antibodies.
Are You a Good Fit for This Trial?
Must be takingLeqembiKisunla
Rules you outSevere depressionDementia other than Alzheimer's disease
You may be able to join if
I am between 55 and 90 years old.
I have been diagnosed with mild cognitive impairment or mild Alzheimer's disease.
I have been receiving treatment with an FDA-approved monoclonal antibody for at least 6 months.
My Mini-Mental State Examination score is between 20 and 26.
I can give my consent to participate.
I have a family member or friend who can help with the study.
You may not be able to join if
I have dementia that is not Alzheimer's disease.
I have severe depression.
I am unable to provide informed consent myself.
I have a recent history of substance abuse.
I have a history of bleeding disorders or certain viral infections.
I have had cancer in the past 3 years except for certain types.
I have uncontrolled medical conditions like high blood pressure or diabetes.
I am currently a transplant recipient.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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City
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Status
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…
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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