RecruitingNot applicable

Robotic-Enabled Microsurgical Intervention for Neurodegenerative Disease

Robotic-Enabled Microsurgical Intervention for Neurodegenerative Disease - A Global, Prospective, Early Feasibility Study in Alzheimer's Patients

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
50 Years and older
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

Not stated in the study description — ask the study team about visits and procedures.

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 the Symani robotic system can safely be used for tiny-vessel surgery near lymph nodes deep in the neck. It is for adults ages 50 to 80 with mild to moderate Alzheimer's disease and problems with the fluid-draining system in their head and neck.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 50 to 80 years old.
  • You have confirmed mild to moderate Alzheimer's disease.
  • A PET brain scan or spinal fluid test shows signs linked to Alzheimer's disease.
  • Your memory and daily function test scores are in the required ranges: MMSE 10–26 and CDR-SB 4.5–9.0 or 9.5–15.5.
  • Scans show problems with the lymph system, which drains fluid, in your head and neck outside the skull.
  • The study doctor decides you can have robot-assisted surgery to connect tiny lymph vessels using the Symani system.
  • If you can become pregnant, you agree to use medically accepted birth control during the study.
  • You or your legal representative gives written consent, and you agree to all study procedures and follow-up visits.

Who can't join

  • You or your legal representative will not give consent, or the study doctor decides you cannot take part for another reason.
  • You may have another type of dementia, or a brain or nerve condition that could affect safety, such as a stroke, tumor, or seizures.
  • You have had radiation to your head or neck, have severe kidney disease (GFR below 30), or have a sudden kidney injury.
  • You have an active infection being treated with antibiotics through a vein, or major disability with a modified Rankin score above 4.
  • You have a serious health condition, a past mental health disorder, or untreated sleep apnea that could affect study results or your ability to follow study rules.
  • You have a history of major bleeding or a blood-clotting disorder, or you have active cancer, current cancer treatment, or cancer treatment within the past 6 months.
  • You receive anti-amyloid antibody treatment for Alzheimer's disease now or received it within the past 3 months.
  • You cannot safely have an MRI or gadobutrol contrast dye injected into spinal fluid, or you are in another research study that could affect safety or results.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. 50 to 80 years of age 2. Patients who are of childbearing potential must agree to use a medically acceptable form of contraception for the duration of the study 3. Patient has confirmed mild to moderate Alzheimer's Disease according to the National Institute of Aging-Alzheimer's Association (NIA-AA) criteria 4. Patient has a positive amyloid PET test and/or a positive CSF t-tau/amyloid-beta-42 test 5. Patient has an MMSE score within the mild to moderate range (21-26 and 10-20) 6. 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 7. Patient has confirmed extracranial lymphatic abnormalities in the head and neck region as identified by preoperative imaging 8. 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) 9. 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: 1. Patient (or their legally authorized representative) is unwilling to provide informed consent 2. Patient has suspected dementia of other type, e.g., Lewy body, frontotemporal disorder, vascular, etc. 3. 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. 4. History of head and neck radiation exposure 5. Patient with severe kidney disease (GFR \<30 mL/min/1.73m2) 6. Patient with acute kidney injury 7. Active systemic infection under treatment with intravenous antibiotics 8. Patient has a modified Rankin Score (mRS) of \>4 9. Clinically significant cardiovascular, digestive, respiratory, endocrine, or central nervous system disorders, previous mental disorders, untreated sleep apnea, or other disorders that may significantly affect the data collection or the ability to comply with the protocol per the investigator's discretion 10. Known history of significant bleeding, coagulopathy, or Von Willebrand's disease 11. Patient with an active cancer diagnosis and/or currently receiving treatment for cancer or has received treatment within the past 6 months 12. Patient is currently receiving treatment or has been treated with anti-amyloid-beta monoclonal antibody therapy within the past 3 months 13. Patient has contraindication for MRI or intrathecal administration of gadobutrol 14. Currently enrolled in any other investigational clinical studies that the investigator believes may impact patient safety or study outcomes 15. Patient is ineligible to participate for other reasons in the judgment of the investigator

Study sites (3)

CA

FL

NY

  • The Research Foundation for State University of New York · Buffalo, NY 14203Ellen Carl · Study contact · ecarl@ubns.comAdnan H Siddiqui · Principal investigatorMore trials in Buffalo