An inventory to assess activities of daily living for clinical trials in Alzheimer's disease. The Alzheimer's Disease Cooperative Study.
D Galasko, D Bennett, M Sano...
https://pubmed.ncbi.nlm.nih.gov/9236950Actively Recruiting
Phase 2
Age: 55Years - 90Years
All Genders
ID07512362
A Pilot Study to Assess the Effect of Adding 1 Infusion of Human Mesenchymal Stem Cells to Patients Treated With Anti-Amyloid Monoclonal Antibodies for Mild Cognitive Impairment or Mild Alzheimer's Disease
Led by Bernard (Barry) Baumel · Updated on 2026-05-28
10
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether adding a single infusion of human mesenchymal stem cells (hMSCs) to the standard treatment with FDA-approved monoclonal antibodies can stabilize cognitive and functional decline in adults aged 55 to 90 with mild cognitive impairment or early Alzheimer's disease. This Phase 2 study focuses on patients already receiving monoclonal antibody therapy for at least six months. The main goal is to observe changes in cognitive function and daily living abilities over time. Participants will receive one intravenous infusion of 25 million human mesenchymal stem cells in addition to their ongoing monoclonal antibody treatment. The study does not include a control or placebo group, and there is no masking or blinding. The intervention is followed by assessments at baseline and at 16, 32, and 48 weeks to monitor changes in cognitive and daily functioning. Throughout the study, participants will undergo evaluations using the Alzheimer's Disease Scale-Cognitive Subscale (ADAS-Cog) and the Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory for Mild Cognitive Impairment (ADCS-MCI-ADL). These assessments will be conducted at multiple time points to track progress. Participants must have a study partner who can report on daily activities, and safety monitoring will continue through the study duration, which lasts nearly one year from the first infusion.
CONDITIONS
Brief Title
Human Mesenchymal Stem Cells & Monoclonal Antibodies in the Treatment for Mild Cognitive Impairment or Early Alzheimer's Disease.
Who Can Participate
Age: 55Years - 90Years
All Genders
Eligibility Criteria
You may qualify if you...
- Adults 55 to 90 years old at the time of signing consent
- Diagnosed with mild cognitive impairment or mild dementia due to Alzheimer's disease
- Receiving FDA-approved monoclonal antibody treatment (Leqembi/Lecanemab or Kisunla/Donanemab) for at least 6 months before infusion
- MMSE score between 20 and 26
- Able to provide informed consent
- Have a study partner who has frequent contact and can answer questions about daily activities
You will not qualify if you...
- Dementia other than Alzheimer's disease
- Severe depression (controlled depression allowed)
- Unable to independently provide informed consent
- Recent history of substance abuse
- History of bleeding disorders, HIV, HCV, or HBV
- Recent malignancies within 3 years, except certain in situ cancers
- Uncontrolled medical conditions like hypertension, diabetes, unstable angina, or recent myocardial infarction
- Currently receiving or recently received experimental Alzheimer's treatments
- Transplant recipients or other active medical conditions compromising safety or study completion
- Premenopausal status
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - Single infusion with follow-up through Week 48
Participants receive one infusion of 25 million human mesenchymal stem cells intravenously while continuing their FDA-approved monoclonal antibody treatment.
1 infusion visit and follow-up visits at Week 16, Week 32, and Week 48
Trial Site Locations
Total: 1 location
1
University of Miami Department of Neurology
Miami, Florida, United States, 33136
Actively Recruiting
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Research Team
M
Maria E. Puertas
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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