Modified deep cervical Lymphatic-V… for Parkinson's (NCT06852352)
Neck drainage surgery slows progression
- Trial ID
- NCT06852352
- Official Title
- A Prospective, Single-center, Single-arm, Exploratory, 24-Month Study to Confirm Efficacy of Modified Deep Cervical Lymphovenous Anastomosis (LVA) in Subjects With Alzheimer's Disease/ Parkinson's Disease
- Goal
- Neck drainage surgery slows progression
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Zhejiang Provincial People's Hospital
- Study Type
- INTERVENTIONAL
- Enrollment
- 160 participants
- Conditions
- Alzheimer Disease, Parkinson Disease
- Interventions
- Modified deep cervical Lymphatic-Venous Anastomosis
Summary For Families
The study is testing whether improving lymphatic drainage from the neck can help the brain clear the harmful protein clumps that build up in Parkinson's and Alzheimer's, with the goal of slowing disease progression and improving quality of life. The approach is a modified deep cervical lymphovenous anastomosis, a surgical connection between neck lymphatic vessels and a vein that has been used to restore drainage in limb swelling, and participants will be followed for two years with brain scans (magnetic resonance imaging and PET-CT), spinal fluid and blood tests, and clinical assessments. Investigators propose the surgery will lower pressure differences inside the skull, increase meningeal lymph flow, and speed removal of brain waste, which could reduce inflammation and nerve-cell injury. The trial is recruiting adults 50 to 75 years old with confirmed Alzheimer's (positive amyloid PET and mild cognitive impairment or dementia) and adults 50 to 80 with Parkinson's who have had the disease for more than two years and are in early to mid stages; participants must be medically fit for surgery and able to undergo imaging and lumbar puncture.
Locations
- Zhejiang Provincial People's Hospital, Hangzhou, Zhejiang, China
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Modified deep cervical Lymphatic-Venous Anastomosis. The study is testing whether improving lymphatic drainage from the neck can help the brain clear the harmful protein clumps that build up in Parkinson's and Alzheimer's, with the goal of slowing disease progression and improving quality of life. The approach is a modified deep cervical lymphovenous anastomosis, a surgical connection between neck lymphatic vessels and a vein that has been used to restore drainage in limb swelling, and participants will be followed for two years with brain scans (magnetic resonance imaging and PET-CT), spinal fluid and blood tests, and clinical assessments. Investigators propose the surgery will lower pressure differences inside the skull, increase meningeal lymph flow, and speed removal of brain waste, which could reduce inflammation and nerve-cell injury. The trial is recruiting adults 50 to 75 years old with confirmed Alzheimer's (positive amyloid PET and mild cognitive impairment or dementia) and adults 50 to 80 with Parkinson's who have had the disease for more than two years and are in early to mid stages; participants must be medically fit for surgery and able to undergo imaging and lumbar puncture.
- Who can participate?
- Participants must be between 50 Years and 80 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This trial is estimated to last approximately 2 years and 4 months.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
- Will I get a placebo in this trial?
- Everyone in this trial receives the experimental treatment. There is no placebo group.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Lumbar puncture (spinal tap) (invasive); MRI scan (non-invasive). Confirm the full schedule with the study coordinator.