Surgery to improve treatment for Alzheimer's disease
Deep Cervical Lymphatlc-Venous Anastomosis Surgery for the Treatment of Alzheimer's Disease: A Pilot Study (DIVA Study)
This study is testing if a new type of surgery, combined with regular medication, can help improve brain function in people with Alzheimer's disease.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Sex | All |
| Sponsor | Zhejiang Provincial People's Hospital Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06530732 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and efficacy of deep cervical lymphatic-venous anastomosis (dcLVA) surgery in patients diagnosed with Alzheimer's disease. Participants will be randomly assigned to receive either the dcLVA surgery combined with standard medication or standard medication alone. The study will involve cognitive assessments, brain MRI scans, and lumbar punctures to measure changes in cognitive function and glymphatic clearance over a 12-month period. The primary outcome will be assessed using the Clinical Dementia Rating Scale scores.
Who should consider this trial
Good fit: Ideal candidates are adults over 35 years old diagnosed with Alzheimer's disease and exhibiting specific cognitive impairment.
Not a fit: Patients with cognitive impairment due to other neurological infections or significant organ dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new surgical option to improve cognitive function in Alzheimer's patients.
How similar studies have performed: While this approach is novel, other studies have explored surgical interventions for neurological conditions, but specific outcomes for this method in Alzheimer's disease are untested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Hangzhou, Zhejiang
- Zhejiang Provincial People's Hospital — Hangzhou, Zhejiang, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.