NCT06530732RecruitingPhase 3
Deep Cervical Lymphatlc-Venous Anastomosis Surgery for the Treatment of Alzheimer's Disease: A Pilot Study (DIVA Study)
Source: ClinicalTrials.gov · Last updated 16 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The goal of this clinical trial is to To demonstrate the Safety and Efficacy of dcLVA Surgery for the Treatment of Alzheimer's Disease. Patients who meet the inclusion and exclusion criteria and consent to participate will be randomly assigned to either the experimental group (receiving dcLVA surgery plus standard medication) or the control group (receiving standard medication alone) Participants will: Undergo cognitive assessment and brain MRI assessment; Undergo a lumbar puncture; Undergo an injection of 20ml of gadodiamide contrast agent at a concentration of 0.5 mmol/L (1ml gadodiamide: 20ml 0.9% saline). Primary Outcome Measures: The change in the sum of Clinical Dementia Rating Scale (CDR) scores at 12-month in relative to baseline
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 28 Jul 2024
- Start date
- 1 Jul 2024
- Primary completion date
- 30 Jun 2026
- Lead sponsor
- Zhejiang Provincial People's Hospital
- Diseases
- Alzheimer disease
- NCT number
- NCT06530732
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 60
- From 1 Jul 2024 to the primary completion date, 30 Jun 2026
- 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.
Other illness
- Cognitive impairment due to neurological infections (e.g., HIV, neurosyphilis, autoimmune encephalitis) or systemic diseases (e.g., diabetes, thyroid dysfunction);
- Significant organ dysfunction (heart, lung, liver, kidney);
- Coagulation disorders or contraindications to surgery;
Other
- Inability to cooperate with lumbar puncture;
- Inability to fully cooperate with follow-up visits.
Who the study is looking for
- Diagnosed as an AD patient according to biological markers and clinical symptoms;
- Over 35 years old and with an MMSE or MOCA score ≤ 26;
- The patient or family member has signed an informed consent form.
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 |
|---|---|---|---|
| Zhejiang Provincial People's Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
Related publications
- Surgical Protocols for Deep Cervical Lymphovenous Anastomosis in a Rat Model: Lymph Node and Lymphatic Vessel Anastomoses.J Vis Exp · 2025 · PMID 41325201
This page is information, not medical advice. Discuss any trial with your doctor.