Robotic Microsurgery for Alzheimer's Disease
(REMIND Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new method to treat Alzheimer’s disease using robotic surgery. The researchers aim to determine if the Symani Surgical System, a robotic microsurgery device, can safely and effectively perform delicate surgeries in the neck area to address lymphatic issues linked to Alzheimer's. They seek individuals with mild to moderate Alzheimer’s disease who have specific lymph node abnormalities and have tested positive for Alzheimer's-related brain changes. Participants must be able to undergo surgery and commit to follow-up visits.
As an unphased trial, this study offers participants a unique opportunity to contribute to groundbreaking research in Alzheimer's treatment.
Do I need to stop my current medications for the trial?
The trial protocol does not specify whether you need to stop taking your current medications. However, if you are currently receiving anti-amyloid-beta monoclonal antibody therapy, you must not have been treated with it in the past 3 months to be eligible.
What prior data suggests that the Symani Surgical System is safe for use in Alzheimer's patients?
Research is examining the safety of the Symani Surgical System for robotic microsurgery. A study before human trials demonstrated that this system is as safe as manual surgery. However, its safety for treating Alzheimer's disease and related lymphatic issues remains under investigation. No proven safety information exists yet for using this system in brain-related lymphatic reconstruction. While early studies suggest safety for some surgeries, its use in this specific area continues to be evaluated.12345
Why are researchers excited about this trial?
Researchers are excited about the Symani Surgical System because it offers a new approach to treating Alzheimer's Disease through robotic microsurgery. Unlike traditional treatments, which primarily focus on managing symptoms with medications like donepezil or memantine, the Symani system aims to directly intervene in the brain with high precision. This robotic technology has the potential to improve surgical outcomes by enhancing the accuracy of delicate procedures, possibly leading to better management of the disease's progression.
What evidence suggests that the Symani Surgical System is effective for Alzheimer's Disease?
Researchers are investigating whether the Symani Surgical System, which participants in this trial will receive, can aid in treating Alzheimer's disease by targeting the lymphatic system. The hypothesis is that enhancing the brain's waste drainage might reduce symptoms or slow disease progression. Although this system has shown promise in other surgeries, its effectiveness for Alzheimer's remains under evaluation in this trial. Early research suggests potential benefits, but further studies are necessary to confirm these findings. Initial signs are positive, but definitive results are not yet available.12356
Are You a Good Fit for This Trial?
This trial is for people aged 50 or older with mild to moderate Alzheimer's disease and confirmed lymphatic issues in the head/neck area. Participants must have certain test results, be able to consent (or have a representative), and be considered suitable for robotic-assisted microsurgery by their doctor.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo the index procedure using the Symani System for microsurgical intervention in the dCLN region
Post-Procedure Monitoring
Participants are monitored for device-related serious adverse events and other adverse events
Follow-up
Participants are monitored for safety and effectiveness, including changes in amyloid PET Centiloid value and plasma biomarkers
What Are the Treatments Tested in This Trial?
Interventions
- Symani Surgical System
Trial Overview
The study tests the safety and practicality of using the Symani Surgical System, a robotic device, to perform precise microsurgery on neck lymph nodes in patients with Alzheimer's disease who also have lymphatic abnormalities.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patient with confirmed mild to moderate Alzheimer's Disease according to the National Institute of Aging-Alzheimer's Association (NIA-AA) criteria
Find a Clinic Near You
Who Is Running the Clinical Trial?
MMI (Medical Microinstruments, Inc.)
Lead Sponsor
Citations
MMI's Symani Surgical System Treats First Alzheimer's ...
FDA-IDE approved study enrolls first patient for robotic-assisted surgical intervention for neurodegenerative disease.
MMI Receives IDE Approval from FDA for First Robotic ...
MMI Receives IDE Approval from FDA for First Robotic Microsurgical Study in Alzheimer's Patients ... The primary endpoint of the study is device- ...
Study Details | NCT07178210 | Robotic-Enabled ...
The objective of this investigational device exemption (IDE) study is to evaluate the safety and feasibility of using the Symani System and microsurgical ...
Clinical Studies
A prospective study to evaluate the safety and effectiveness of the Symani Surgical System for microsurgical anastomosis during free tissue transfer surgery and ...
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clinicaltrialsarena.com
clinicaltrialsarena.com/news/mmi-wins-ide-for-surgical-robotic-alzheimer-disease-study/MMI wins IDE for surgical robotic Alzheimer's disease study
MMI's REMIND study will evaluate its Symani surgical robot in reestablishing lymphatic drainage pathways to treat Alzheimer's disease.
Safety and efficacy of Symani robotic-assisted microsurgery
Conclusion: This preclinical study demonstrated the safety of the Symani surgical system. Results suggest equivalence between robotic and manual techniques ...
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