Alzheimer DiseaseREMINDNCT07178210
Robotic-Enabled Microsurgical Intervention for Neurodegenerative Disease
A study testing Symani Surgical System in people with Alzheimer Disease and Lymphatic Obstruction, run by MMI (Medical Microinstruments, Inc.) at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Alzheimer Disease, Lymphatic Obstruction
- What is being tested?
- Symani Surgical System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 3 sitesUnited States
- Study dates
- 30 Apr 2026to 30 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 50 to 80 years of age
- Patients who are of childbearing potential must agree to use a medically acceptable form of contraception for the duration of the study
- 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
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- 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
Who cannot join
- 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
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- 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, 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
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
The Research Foundation for State University of New York
Buffalo, New York, 14203
Ellen Carl, ecarl@ubns.com
Adnan H Siddiqui
- Recruiting
Baptist Health Research Institute
Jacksonville, Florida, 32207
Karen Yesensky, 904-202-7091, Karen.Yesensky@bmcjax.com
Ricardo Hanel, MD, PhD
- Recruiting
Stanford Medical Center
Palo Alto, California, 94305
Elizabeth Tadevosyan, etadyan@stanford.edu
Dung Nguyen, MD
About this study
Official title: Robotic-Enabled Microsurgical Intervention for Neurodegenerative Disease - A Global, Prospective, Early Feasibility Study in Alzheimer's Patients
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.
Read the detailed description
A prospective, multi-center, early feasibility study, designed to evaluate the Symani System's safety and feasibility for performing microsurgical techniques in the dCLN region to improve clearance of neurotoxins, such as amyloid-beta and phosphorylated tau, in patients with confirmed mild to moderate Alzheimer's disease and lymphatic abnormalities in the dCLN region.
- Conditions
- Alzheimer Disease, Lymphatic Obstruction
- Being tested
- Symani Surgical System
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Symani Surgical SystemDevice
Use of Symani Surgical System for performing microsurgical techniques in the deep cervical lymph nodes.
| Study group | Role | What they receive |
|---|---|---|
| Alzheimer's Disease | Experimental | Patient with confirmed mild to moderate Alzheimer's Disease according to the National Institute of Aging-Alzheimer's Association (NIA-AA) criteria Receives: Device: Symani Surgical System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device-related serious adverse events at 30-days
All intraoperative and postoperative device-related serious adverse events (SAEs) will be captured from the start of the index procedure through 30 days post-index procedure for each participant. The device-related SAE rate will be reported at 30 days post-index procedure for all evaluable participants.
Measured: The duration of the participants' index procedure through 30-days post index procedure.
Secondary outcomes (7)
Rate of Serious Adverse Events (SAEs) at 6 months
All intraoperative and postoperative SAEs, regardless of device relatedness, will be captured from the start of the index procedure through 6 months days post-index procedure for each participant. The freedom from SAE rate will be reported at 6 months post-index procedure for all evaluable participants.
Measured: The duration of the participants' index procedure through 6-months post index procedure.
Rate of Adverse Events (AEs) at 30 days
All intraoperative and postoperative AEs, regardless of seriousness or device relatedness, will be captured from the start of the index procedure through 3 months days post-index procedure for each participant. The freedom from AE rate will be reported at 3 months post-index procedure for all evaluable participants.
Measured: The duration of the participants' index procedure through 30-days post index procedure.
Anastomosis-Specific Reoperation Rate at 30 Days
An anastomosis-specific reoperation is defined as a reoperation to revise a robotic anastomosis, which may consist of the addition of stitches, the removal of stitches, or any other form of reoperation directly to robotic anastomoses performed in the index procedure. All anastomosis-specific reoperations will be captured from the end of the index procedure through 30 days post-index procedure for each participant. All anastomosis-specific reoperations will be reviewed by a DSMB Charter. The anastomosis-specific reoperation rate will be reported at 30 days post-index procedure for all evaluable participants.
Measured: The duration of the participants' index procedure through 30-days post index procedure.
Change in Amyloid PET Centiloid Value at 6 Months
The centiloid (CL) value of an amyloid positron emission tomography (PET) imaging test will be recorded at the patient's pre-procedure visit and at the 6-month follow-up visit.
Measured: The duration of the participants' pre-procedure visit through 6-months post index procedure.
Change in Plasma Biomarkers at 6 Months: amyloidβ-42 and 40, ptau-217, NfL and GFAP
Blood panel testing for amyloidβ-42 and 40, ptau-217, neurofilament light chain (NfL) and glial fibrillary acidic protein (GFAP) will be taken at the patient's pre-procedure visit and at the 6-month follow-up visit.
Measured: The duration of the participants' pre-procedure visit through 6-months post index procedure.
Anastomosis Patency Prior to Closure
Intraoperative patency of the anastomosis should be assessed prior to closure per site standard of care. This information will be captured for each robotic anastomosis performed during the procedure.
Measured: The duration of the participants' index procedure.
Intraoperative Conversion to Manual Approach
The rate of conversion to manual approach will be measured during the index procedure for each participant. This information will be captured for each robotic anastomosis performed during the procedure.
Measured: The duration of the participants' index procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study start30 Apr 2026
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MMI (Medical Microinstruments, Inc.)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07178210
- Sponsor's protocol ID
- CDC-00157
- Acronym
- REMIND
- Status last verified
- Aug 2026
- First submitted
- 9 Sep 2025
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic-Enabled Microsurgical Intervention for Neurodegenerative Disease - A Global, Prospective, Early Feasibility Study in Alzheimer's Patients
- ClinicalTrials.gov ID
- NCT07178210
- Acronym / sponsor ID
- REMIND / CDC-00157
- Conditions
- Alzheimer Disease, Lymphatic Obstruction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- MMI (Medical Microinstruments, Inc.)Industry (pharma, biotech, devices)
- Study start
- 30 Apr 2026 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Oct 2027 (estimated)
- First posted
- 17 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A prospective, multi-center, early feasibility study, designed to evaluate the Symani System's safety and feasibility for performing microsurgical techniques in the dCLN region to improve clearance of neurotoxins, such as amyloid-beta and phosphorylated tau, in patients with confirmed mild to moderate Alzheimer's disease and lymphatic abnormalities in the dCLN region.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alzheimer's Disease | Experimental | Device: Symani Surgical SystemPatient with confirmed mild to moderate Alzheimer's Disease according to the National Institute of Aging-Alzheimer's Association (NIA-AA) criteria |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 50 to 80 years of age
- Patients who are of childbearing potential must agree to use a medically acceptable form of contraception for the duration of the study
- 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)
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Symani Surgical SystemUse of Symani Surgical System for performing microsurgical techniques in the deep cervical lymph nodes. | Device | Alzheimer's Disease |
Primary outcome
Device-related serious adverse events at 30-days
Time frame: The duration of the participants' index procedure through 30-days post index procedure.
All intraoperative and postoperative device-related serious adverse events (SAEs) will be captured from the start of the index procedure through 30 days post-index procedure for each participant. The device-related SAE rate will be reported at 30 days post-index procedure for all evaluable participants.
7 secondary outcomes
Rate of Serious Adverse Events (SAEs) at 6 months
Time frame: The duration of the participants' index procedure through 6-months post index procedure.
Rate of Adverse Events (AEs) at 30 days
Time frame: The duration of the participants' index procedure through 30-days post index procedure.
Anastomosis-Specific Reoperation Rate at 30 Days
Time frame: The duration of the participants' index procedure through 30-days post index procedure.
Change in Amyloid PET Centiloid Value at 6 Months
Time frame: The duration of the participants' pre-procedure visit through 6-months post index procedure.
Change in Plasma Biomarkers at 6 Months: amyloidβ-42 and 40, ptau-217, NfL and GFAP
Time frame: The duration of the participants' pre-procedure visit through 6-months post index procedure.
Anastomosis Patency Prior to Closure
Time frame: The duration of the participants' index procedure.
Intraoperative Conversion to Manual Approach
Time frame: The duration of the participants' index procedure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Symani Surgical System in people with Alzheimer Disease and Lymphatic Obstruction, run by MMI (Medical Microinstruments, Inc.) at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Operations (8336646276 ext. 5, clinical.ops@mmimicro.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device-related serious adverse events at 30-days (time frame: The duration of the participants' index procedure through 30-days post index procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.