An interventional study of Symani Surgical System in Alzheimer's, sponsored by MMI (Medical Microinstruments, Inc.). Not yet recruiting. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-16.
Sponsored by MMI (Medical Microinstruments, Inc.) · Not applicable, Interventional, and Treatment
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.
A prospective, multicenter open label study, designed to evaluate the Symani System's safety and feasibility for performing microsurgical techniques in the dCLNs to improve clearance of neurotoxins, such as amyloid-beta and phosphorylated tau, in patients with confirmed highly probable or probable Alzheimer's Disease, according to the International Working Group (IWG) and a positive core 1 Alzheimer biomarker according to the Alzheimer's Association (AA) criteria.
2,372 studies on the registry are indexed under Dementia; 574 are open to participants now.
This study's planned enrollment of 50 is below the median of 90 across 1,758 interventional studies indexed under Dementia.
Browse Dementia studies →MMI (Medical Microinstruments, Inc.) is the lead sponsor of 8 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Preoperative Inclusion Criteria:
Intraoperative Inclusion Criteria:
1. Intraoperative imaging confirms lymphatic nodes/vessels amenable to reconstruction
Preoperative Exclusion Criteria:
Intraoperative Exclusion Criteria:
1. Any presenting condition discovered intraoperatively that, in the opinion of the investigator, would make participating in this study not in the patient's best interest
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patient with confirmed mild to moderate Alzheimer's Disease according to the International Working Group (IWG) and a positive core 1 Alzheimer biomarker according to the Alzheimer's Association (AA) criteria.
Device: Symani Surgical System
Use of Symani Surgical System for performing microsurgical techniques in the deep cervical lymph nodes.
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.
Time frame: The duration of the participants' index procedure through 30-days post index procedure.
Rate of Serious Adverse Events (SAEs) through 12 months
All intraoperative and postoperative SAEs, regardless of device relatedness, will be captured from the start of the index procedure through 12 months post-index procedure for each participant. The freedom from SAE rate will be reported through 12 months post-index procedure for all evaluable participants.
Time frame: The duration of the participants' index procedure through 12-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 30 days post-index procedure for each participant. The freedom from AE rate will be reported at 30 days post-index procedure for all evaluable participants.
Time frame: The duration of the participants' index procedure through 30-days post index procedure.
Incidence of Post Operative Delirium
Post Operative Delirium occurrence shall be collected from the end of the indexing procedure through discharge, as an AE.
Time frame: From Day 0 visit through 12-24 hours prior to discharge.
Change in Amyloid PET Centiloid Value at 6 and 12- Months
The centiloid (CL) value of an amyloid positron emission tomography (PET) imaging test will be performed at the patient's pre-procedure visit and at the 6 and 12-month follow-up visit for this comparison.
Time frame: The duration of the participants' pre-procedure visit through 6 and 12-months post index procedure.
Change in Plasma Biomarkers at 3, 6, and 12 Months: amyloidβ-42 and 40, amyloidβ-42/40 ratio, ptau-217, NfL and GFAP
Blood panel testing for amyloidβ-42 and 40, amyloidβ-42/40 ratio, 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 3, 6, and 12-month follow-up visits.
Time frame: The duration of the participants' pre-procedure visit through 3, 6, and 12-months post index procedure.
Change in Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) Score at 6 and 12 Months
CDR-SB will be evaluated at the patient's pre-procedure visit and at the 6 and 12-month follow-up visit. The CDR-SB scores can take a value between 0 and 18.
Time frame: The duration of the participants' pre-procedure visit through 6 and 12-months post index procedure.
Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) Domains at 6 and 12 Months
Each of the 6 domains of the CDR-SB -- memory, orientation, judgement, problem solving, community affairs, home and hobbies, and personal care -- will be evaluated at the patient's pre-procedure visit and at the 6 and 12-month follow-up visit.
Time frame: The duration of the participants' pre-procedure visit through 6 and 12-months post index procedure.
Alzheimer's Disease Assessment Scvale-Cognitive (ADAS-Cog14) at 6 and 12 months
ADAS-Cog14 will be evaluated at the patient's pre-procedure visit and at the 6 and 12-month follow-up visit. The scores range from 0 to 70.
Time frame: The duration of the participants' pre-procedure visit through 6 and 12-months post index procedure.
Mini-Mental State Examination (MMSE) at 6 and 12 Months
MMSE will be evaluated at the patient's pre-procedure visit and at the 6 and 12-month follow-up visit. The scores range from 0 to 30.
Time frame: The duration of the participants' pre-procedure visit through 6 and 12-months post index procedure.
Activities of Daily Living (ADSC-ADL) at 6 and 12-Months
ADSC-ADL will be evaluated at the patient's pre-procedure visit and at the 6-month follow-up visit. The scores range from 0 to 78. Questions are asked of the patient's caregiver/family member to best gauge the patient's ability to complete basic and instrumental activities of daily living
Time frame: The duration of the participants' pre-procedure visit through 6 and 12-months post index procedure.
Change in Zarit Burden Interview (ZBI) at 6 and 12 months
The ZBI shall be administered at the patient's pre-procedural visit and at the 6 and 12-month visits. This 22-item scale is administered to the patient's caregiver/family member to assess the caregiver's burden.
Time frame: The duration of the participants' pre-procedure visit through 6 and 12-months post index procedure.
No study locations are listed for this record.
Start is estimated for Oct 2026; primary completion for Apr 2028, 18 months later.
Of 46 industry-sponsored interventional studies with no phase under Dementia, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 35. This study's planned 18 months is close to that.
Counting every sponsor, half of 901 studies reached it within 25 months; a quarter within 11 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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MMI (Medical Microinstruments, Inc.)