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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
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.
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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.