NCT06530732 Deep Cervical Lymphatlc-Venous Anastomosis Surgery for the Treatment of Alzheimer's Disease: A Pilot Study (DIVA Study)
| NCT ID | NCT06530732 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Zhejiang Provincial People's Hospital |
| Condition | Alzheimer's Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-07-01 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 60 participants in total. It began in 2024-07-01 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Inability to cooperate with lumbar puncture; * 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; * Inability to fully cooperate with follow-up visits.
Frequently Asked Questions
Who can join the NCT06530732 clinical trial?
This trial is open to participants of all sexes, studying Alzheimer's Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06530732 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 60 participants.
Is NCT06530732 currently recruiting?
Yes, NCT06530732 is actively recruiting participants. Visit ClinicalTrials.gov or contact Zhejiang Provincial People's Hospital to inquire about joining.
Where is the NCT06530732 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT06530732 clinical trial?
NCT06530732 is sponsored by Zhejiang Provincial People's Hospital. The trial plans to enroll 60 participants.
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