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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alzheimer's Disease | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Symani Surgical System | Device | Use of Symani Surgical System for performing microsurgical techniques in the deep cervical lymph nodes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | The duration of the participants' index procedure through 30-days post index procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | The duration of the participants' index procedure through 12-months post index procedure. |
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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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Operations | Contact | 8336646276 | 5 | clinical.ops@mmimicro.com |
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| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D000544 | Alzheimer Disease |
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| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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 | 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. | The duration of the participants' pre-procedure visit through 6 and 12-months post index procedure. |