Robotic-Enabled Microsurgical Intervention for Neurodegenerative Disease - EU (NCT07708675) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Robotic-Enabled Microsurgical Intervention for Neurodegenerative Disease - EU
50 participantsStarted 2026-10-01
Plain-language summary
The objective of this study is to evaluate the safety and feasibility of the Symani System and microsurgical techniques in the deep Cervical Lymph Node (dCLN) region in patients with confirmed Alzheimer's disease.
Who can participate
Age range
50 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patient aged 50 to \< 80 years
. Patient has confirmed highly probable or probable Alzheimer's disease according to the International Working Group (IWG) Patient and has a positive core 1 Alzheimer biomarker according to the Alzheimer's Association (AA) criteria
. Patient has an MMSE score≥ 18
. 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)
. Patients who are of childbearing potential must agree to use a medically acceptable form of contraception.
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is labeled as 'not yet recruiting' — do you know when it's expected to open, and whether it would be worth waiting for versus pursuing other options now?
2The main thing this trial is measuring is serious device-related adverse events at 30 days, which tells me they're primarily focused on safety rather than whether it actually improves Alzheimer's symptoms — does that change how you'd weigh it as an option for me?
3Since this involves robotic-assisted microsurgery for a neurodegenerative disease, can you help me understand what surgical procedure is actually being performed on the brain and what the realistic risks would be for someone in my situation?
4This trial is based in the EU — is that a logistical possibility for me, and how would participating in a trial abroad affect my ongoing care with you?
5Given that this appears to be an early-stage safety study rather than a treatment effectiveness trial, do you think there are any currently available treatments or other studies I should be exploring at the same time?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Device-related serious adverse events at 30-days
Timeframe: The duration of the participants' index procedure through 30-days post index procedure.
. 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
. Documented history of clinically significant diagnosis of cardiovascular, digestive, respiratory, endocrine, or central nervous system disorders, untreated sleep apnea, 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