Alzheimer's
Conditions
Keywords
Dementia, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Tauopathies, Neurodegenerative Diseases, Neurocognitive Disorders, Mental Disorders, Alzheimer Disease
Brief 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.
Detailed description
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.
Interventions
DEVICESymani Surgical System
Use of Symani Surgical System for performing microsurgical techniques in the deep cervical lymph nodes.
Sponsors
MMI (Medical Microinstruments, Inc.)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Preoperative Inclusion Criteria: 1. Patient aged 50 to \< 80 years 2. 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 3. Patient has an MMSE score≥ 18 4. 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) 5. Patients who are of childbearing potential must agree to use a medically acceptable form of contraception. 6. 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 Intraoperative Inclusion Criteria: 1\. Intraoperative imaging confirms lymphatic nodes/vessels amenable to reconstruction Preoperative
Exclusion criteria
1. Patient (or their legally authorized representative) is unwilling to provide informed consent 2. Patient has suspected dementia of other type, e.g., Lewy body, frontotemporal disorder, vascular, etc. 3. History of head and neck radiation exposure 4. Patient with severe kidney disease (GFR \<30 mL/min/1.73m2) 5. Patient with acute kidney injury 6. Active systemic infection under treatment with intravenous antibiotics 7. Patient has a modified Rankin Score (mRS) of \>4 8. 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 9. Known history of significant bleeding, coagulopathy, or Von Willebrand's disease 10. Patient with an active cancer diagnosis and/or currently receiving treatment for cancer or has received treatment within the past 6 months 11. Patient is currently receiving treatment or has been treated with anti-amyloid-beta monoclonal antibody therapy within the past 6 months 12. Patient has contraindication for MRI 13. Currently enrolled in any other investigational clinical studies that the investigator believes may impact patient safety or study outcomes 14. Patient is ineligible to participate for other reasons in the judgment of the investigator Intraoperative
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device-related serious adverse events at 30-days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Serious Adverse Events (SAEs) through 12 months | The duration of the participants' index procedure through 12-months post index procedure. | 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. |
| Rate of Adverse Events (AEs) at 30 days | The duration of the participants' index procedure through 30-days post index procedure. | 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. |
| Incidence of Post Operative Delirium | From Day 0 visit through 12-24 hours prior to discharge. | Post Operative Delirium occurrence shall be collected from the end of the indexing procedure through discharge, as an AE. |
| Change in Amyloid PET Centiloid Value at 6 and 12- Months | The duration of the participants' pre-procedure visit through 6 and 12-months post index procedure. | 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. |
| Change in Plasma Biomarkers at 3, 6, and 12 Months: amyloidβ-42 and 40, amyloidβ-42/40 ratio, ptau-217, NfL and GFAP | The duration of the participants' pre-procedure visit through 3, 6, and 12-months post index procedure. | 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. |
| Change in Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) Score at 6 and 12 Months | The duration of the participants' pre-procedure visit through 6 and 12-months post index procedure. | 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. |
| Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) Domains at 6 and 12 Months | The duration of the participants' pre-procedure visit through 6 and 12-months post index procedure. | 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. |
| Alzheimer's Disease Assessment Scvale-Cognitive (ADAS-Cog14) at 6 and 12 months | The duration of the participants' pre-procedure visit through 6 and 12-months post index procedure. | 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. |
| Mini-Mental State Examination (MMSE) at 6 and 12 Months | The duration of the participants' pre-procedure visit through 6 and 12-months post index procedure. | 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. |
| Activities of Daily Living (ADSC-ADL) at 6 and 12-Months | The duration of the participants' pre-procedure visit through 6 and 12-months post index procedure. | 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 |
| Change in Zarit Burden Interview (ZBI) at 6 and 12 months | The duration of the participants' pre-procedure visit through 6 and 12-months post index procedure. | 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. |
Contacts
CONTACTClinical Operations
Outcome results
None listed