NCT07178210 · MMI (Medical Microinstruments, Inc.)
Robotic-Enabled Microsurgical Intervention for Neurodegenerative Disease
(REMIND)
What this study is about
The objective of this experimental device exemption (IDE) study is to evaluate the safety and feasibility of using the Symani System and microsurgical techniques in the deep cervical lymph node (dCLN) region in the setting of mild to moderate Alzheimer's disease and lymphatic abnormalities.
View original scientific description
The objective of this investigational device exemption (IDE) study is to evaluate the safety and feasibility of using the Symani System and microsurgical techniques in the deep cervical lymph node (dCLN) region in the setting of mild to moderate Alzheimer's disease and lymphatic abnormalities.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Patient aged 50 or older
- Patient has confirmed mild to moderate Alzheimer's Disease according to the National Institute of Aging-Alzheimer's Association (NIA-AA) criteria
- Patient has a positive amyloid PET test and/or a positive CSF t-tau/amyloid-beta-42 test
- Patient has an MMSE score within the mild to moderate range (21-26 and 10-20)
- Patient has CDR-SB score within the mild to moderate range; mild is 4.5to 9.0 and moderate is 9.5 to 15.5
- Patient has confirmed extracranial lymphatic abnormalities in the head and neck region as identified by preoperative imaging
- Investigator deems the candidate acceptable for lymphatic surgery with a robotic-assisted microsurgical anastomosis in accordance with the Symani System's Instructions for Use (IFU)
- Patient or their legally authorized representative agrees to participate in the study, return for all required follow-up visits, complete all study procedures, and has willingly provided written informed consent after receiving all information related to the study, its requirements, and the robotic assisted procedure
Exclusion criteria
- Patient (or their legally authorized representative) is unwilling to provide informed consent
- Patient has suspected dementia of other type, e.g., Lewy body, frontotemporal disorder, vascular, etc.
- Patient has documented or suspected neurological or intracranial conditions such as cerebrovascular accident, tumors, intracranial space occupying lesions, seizures or other intracranial/neurological conditions that may affect their safety in the study.
- History of head and neck radiation exposure
- Patient with severe kidney disease (GFR \<30 mL/min/1.73m2)
- Patient with acute kidney injury
- Active systemic infection under treatment with intravenous antibiotics
- Patient has a modified Rankin Score (mRS) of \>4
- Clinically significant cardiovascular, digestive, respiratory, endocrine, or central nervous system disorders, previous mental disorders, or other disorders that may significantly affect the data collection or the ability to comply with the protocol per the investigator's discretion
- Known history of significant bleeding, coagulopathy, or Von Willebrand's disease
- Patient with an active cancer diagnosis and/or currently receiving treatment for cancer or has received treatment within the past 6 months
- Patient is currently receiving treatment or has been treated with anti-amyloid-beta monoclonal antibody therapy within the past 3 months
- Patient has contraindication for MRI or intrathecal administration of gadobutrol
- Currently enrolled in any other investigational clinical studies that the investigator believes may impact patient safety or study outcomes
- Patient is ineligible to participate for other reasons in the judgment of the investigator
Where
- Palo Alto, California
- Jacksonville, Florida
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 2, 2026 · Source of record for eligibility and locations