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New treatment option for Alzheimer Disease
Official title Robotic-Enabled Microsurgical Intervention for Neurodegenerative Disease
ClinicalTrials.gov ID: NCT07178210
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older
You may be able to join if
- 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
You likely can't join if
- 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...
- History of head and neck radiation exposure
- Patient with severe kidney disease (GFR \<30 mL/min/1.73m2)
- Patient with acute kidney injury
See the full eligibility 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Palo Alto, California, United States
- Jacksonville, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Palo Alto, California, United States; Jacksonville, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.