NCT07458620Not yet recruitingPhase 1
Prospective Single-Arm Safety Study of Cervical LVA in AD Patients
Prospective Single-Arm Safety Study of Cervical Lymphaticovenular Anastomosis (LVA) in Patients With Alzheimer's Disease
Source: ClinicalTrials.gov · Last updated 9 Mar 2026
Brief summary (registry, in English)
Official Title Prospective Single-Arm Safety Study of Cervical Lymphaticovenular Anastomosis (LVA) in Patients with Alzheimer's Disease Purpose of the Study Researchers are conducting this study to see if a minimally invasive microsurgery, called Cervical Lymphaticovenular Anastomosis (LVA), is safe for people with Alzheimer's Disease. How the Surgery Works Alzheimer's Disease is linked to the buildup of metabolic waste products (certain proteins) in the brain. Recent medical discoveries show that these wastes normally drain through small channels in the neck into the blood system. In this study, surgeons will use high-powered microscopes to connect these drainage channels (lymphatic vessels) in the neck directly to small nearby veins. The goal is to create a "detour" that helps the brain clear out these harmful proteins more effectively. What to Expect Safety First: The main goal is to find out if the surgery is safe and well-tolerated by patients. The Procedure: The surgery is performed under general anesthesia and typically takes 4 to 6 hours. It involves small (about 5 cm) incisions on both sides of the neck. Follow-up: Participants will be monitored for at least 12 months. Researchers will use memory tests, brain scans (MRI and PET), and blood tests to see if the surgery helps with daily activities or slows down memory loss.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 35 (estimated)
- First submitted
- 22 Feb 2026
- Start date
- Mar 2026
- Primary completion date
- May 2027
- Lead sponsor
- Chang Gung Memorial Hospital
- Diseases
- Alzheimer disease
- NCT number
- NCT07458620
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 35
- From Mar 2026 to the primary completion date, May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior Surgical History: Individuals who have previously undergone neck lymphatic dissection, nasopharyngeal surgery, or intracranial surgery are excluded.
- Concurrent Medical Conditions: The trial excludes persons with thyroid disease or chronic heart failure.
Other illness
- Specific Allergies: Candidates with a history of allergies to shellfish or iodine are excluded due to the use of Indocyanine Green (ICG) during the procedure.
- Anesthesia Risks: Individuals deemed medically unfit for general anesthesia-for example, those with severe cardiopulmonary insufficiency or a history of specific anesthetic drug allergies-are ineligible.
Other
- Lack of Informed Consent: Potential participants are excluded if they are unable to exercise autonomy and informed consent cannot be obtained from a legal representative or authorized person.
- Unresolved Concerns: Anyone who has doubts about the trial and cannot receive satisfactory answers is excluded.
Who the study is looking for
- Diagnosis of Alzheimer's Disease: Participants must have a confirmed diagnosis of Alzheimer's Disease as evaluated by a neurologist and a psychiatrist at the hospital.
- Positive Amyloid-PET Scan: The result of a \[18F\] Florbetapir (Amyloid-PET) scan must be positive, indicating the presence of amyloid plaques in the brain.
- Willingness to Consent: Participants or their legal representatives must be willing to sign a written informed consent form.
- Participants must be adults aged 18 years or older
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kaohsiung Chang Gung Memorial Hospital Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.