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.
New trial tests stem cells with Alzheimer's antibody drugs
Plain English Summary
Human Mesenchymal Stem Cells & Monoclonal Antibodies in the Treatment for Mild Cognitive Impairment or Early Alzheimer's Disease. is a Phase 2 clinical trial sponsored by Bernard (Barry) Baumel studying Mild Cognitive Impairment, Early Alzheimer's Disease, AD-MCI. This trial tests if adding a one-time infusion of stem cells to existing antibody treatments can help slow cognitive decline in early Alzheimer's. It is for adults aged 55-90 diagnosed with mild cognitive impairment or early Alzheimer's who are already on specific antibody medications. Participants will receive one stem cell infusion and undergo regular assessments over 48 weeks. Alternative treatments include continuing current antibody therapy or other supportive care for Alzheimer's. The trial aims to enroll 10 participants.
Official Summary
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.
Who Can Participate
Here is what you need to know about eligibility for this trial. You can join if you are 55-90 years old, have mild cognitive impairment or early Alzheimer's, and have been on an FDA-approved Alzheimer's antibody drug (like Leqembi or Donanemab) for at least 6 months. You need to have a score between 20-26 on a cognitive test (MMSE) and have a reliable study partner who can help track your daily activities. You cannot join if you have dementia from causes other than Alzheimer's, severe depression, a history of bleeding disorders, or certain other serious medical conditions. You also cannot join if you have had certain cancers recently, have uncontrolled medical conditions like high blood pressure or diabetes, or are currently in other Alzheimer's drug trials. This trial is studying Mild Cognitive Impairment, Early Alzheimer's Disease, AD-MCI, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcome measures how a standard cognitive test (ADAS-Cog) changes over time, indicating whether the combined treatment helps maintain thinking abilities. The specific primary outcome measures are: Change in Alzheimer's Disease Scale-Cognitive Subscale (ADAS-Cog) (Baseline, Week 16, Week 32, and Week 48). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.
Why This Trial Matters
This trial addresses a critical need for new therapies to stabilize cognitive and functional decline in early Alzheimer's disease, a condition with limited effective treatment options. Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Mild Cognitive Impairment, Early Alzheimer's Disease, AD-MCI, where improved treatment options are needed.
Investor Insight
This pilot study explores a novel combination therapy for a growing market of Alzheimer's patients, with potential to enhance existing treatments and improve patient outcomes. Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.
Is This Trial Right for Me?
Ask your doctor if this trial is right for you, especially regarding the stem cell infusion and the need for a study partner. Participation involves one stem cell infusion and regular visits for cognitive tests and assessments over approximately one year. Your study partner will need to be available to answer questions about your daily activities throughout the trial. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: NA
- Model: SINGLE_GROUP
- Masking: NONE
- Enrollment: 10 participants
Interventions
- BIOLOGICAL: human Mesenchymal Stem Cells — Patients eligible to participate will receive one infusion of 25 million cells administered intravenously.
Primary Outcomes
- Change in Alzheimer's Disease Scale-Cognitive Subscale (ADAS-Cog) (Baseline, Week 16, Week 32, and Week 48)
Secondary Outcomes
- Change in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory for Mild Cognitive Impairment (ADCS-MCI -ADL) (Baseline, Week 16, Week 32, and Week 48)
Full 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
Trial Locations
- University of Miami Department of Neurology, Miami, Florida, United States
Frequently Asked Questions
What is clinical trial NCT07512362?
NCT07512362 is a Phase 2 INTERVENTIONAL study titled "Human Mesenchymal Stem Cells & Monoclonal Antibodies in the Treatment for Mild Cognitive Impairment or Early Alzheimer's Disease.." It is currently not yet recruiting and is sponsored by Bernard (Barry) Baumel. The trial targets enrollment of 10 participants.
What conditions does NCT07512362 study?
This trial investigates treatments for Mild Cognitive Impairment, Early Alzheimer's Disease, AD-MCI. The primary condition under study is Mild Cognitive Impairment.
What treatments are being tested in NCT07512362?
The interventions being studied include: human Mesenchymal Stem Cells (BIOLOGICAL). Patients eligible to participate will receive one infusion of 25 million cells administered intravenously.
What does Phase 2 mean for NCT07512362?
Phase 2 trials test whether the treatment works for the intended condition. They involve 100-300 patients and continue to evaluate safety while measuring effectiveness.
What is the current status of NCT07512362?
This trial is currently "Not Yet Recruiting." It started on 2026-06-15. The estimated completion date is 2028-06-15.
Who is sponsoring NCT07512362?
NCT07512362 is sponsored by Bernard (Barry) Baumel. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07512362?
The trial aims to enroll 10 participants. The trial has not yet started recruiting.
How is NCT07512362 designed?
This is a interventional study, uses na allocation, follows a single_group design, employs none masking.
What are the primary outcomes being measured in NCT07512362?
The primary outcome measures are: Change in Alzheimer's Disease Scale-Cognitive Subscale (ADAS-Cog) (Baseline, Week 16, Week 32, and Week 48). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07512362 being conducted?
This trial is being conducted at 1 site, including Miami, Florida (United States).
Where can I find official information about NCT07512362?
The official record for NCT07512362 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07512362. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07512362 testing in simple terms?
This trial tests if adding a one-time infusion of stem cells to existing antibody treatments can help slow cognitive decline in early Alzheimer's. It is for adults aged 55-90 diagnosed with mild cognitive impairment or early Alzheimer's who are already on specific antibody medications.
Why is this trial significant?
This trial addresses a critical need for new therapies to stabilize cognitive and functional decline in early Alzheimer's disease, a condition with limited effective treatment options.
What are the potential risks of participating in NCT07512362?
The main risks involve potential reactions to the stem cell infusion, such as fever or allergic responses. Other side effects could include temporary worsening of cognitive or functional abilities, or reactions related to the ongoing antibody treatment. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07512362?
Ask your doctor if this trial is right for you, especially regarding the stem cell infusion and the need for a study partner. Participation involves one stem cell infusion and regular visits for cognitive tests and assessments over approximately one year. Your study partner will need to be available to answer questions about your daily activities throughout the trial. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07512362 signal from an investment perspective?
This pilot study explores a novel combination therapy for a growing market of Alzheimer's patients, with potential to enhance existing treatments and improve patient outcomes. This is a Phase 2 trial, which is focused on confirming efficacy before larger pivotal studies.
What happens if the treatment in this trial doesn't work?
Participants will receive one stem cell infusion and undergo regular assessments over 48 weeks. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
More Mild Cognitive Impairment Trials
This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.