Surgery to reduce protein buildup
- 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
- Surgery to reduce protein buildup
- 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
Aimed at improving brain waste clearance in Alzheimer's and Parkinson's, the trial tests whether surgically connecting deep cervical lymphatic vessels into nearby veins can reduce buildup of proteins like amyloid and alpha-synuclein and slow symptom progression over 24 months. The procedure, a modified deep cervical lymphatic-venous anastomosis, creates a new drainage route so cerebrospinal and interstitial fluid can leave the brain more efficiently, and it would be used alongside, not instead of, standard medications. They are looking for adults in two groups: people with Alzheimer's aged 50 to 75 who have positive amyloid PET scans, and people with Parkinson's aged 50 to 80 with Hoehn and Yahr stage I to IV and at least a couple years of stable symptoms. Candidates must be able to consent and be medically fit for MRI, PET, lumbar puncture, and surgery, and people with serious medical, bleeding, or uncontrolled psychiatric conditions are excluded.
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. Aimed at improving brain waste clearance in Alzheimer's and Parkinson's, the trial tests whether surgically connecting deep cervical lymphatic vessels into nearby veins can reduce buildup of proteins like amyloid and alpha-synuclein and slow symptom progression over 24 months. The procedure, a modified deep cervical lymphatic-venous anastomosis, creates a new drainage route so cerebrospinal and interstitial fluid can leave the brain more efficiently, and it would be used alongside, not instead of, standard medications. They are looking for adults in two groups: people with Alzheimer's aged 50 to 75 who have positive amyloid PET scans, and people with Parkinson's aged 50 to 80 with Hoehn and Yahr stage I to IV and at least a couple years of stable symptoms. Candidates must be able to consent and be medically fit for MRI, PET, lumbar puncture, and surgery, and people with serious medical, bleeding, or uncontrolled psychiatric conditions are excluded.
- 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?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 2 years and 4 months.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- 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.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- 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.