Deep Cervical Lymphatlc-Venous Anastomosis Surgery for the Treatment of Alzheimer's Disease: A Pilot Study (DIVA Study)
Recruiting
Phase 3Interventional Study
Alzheimer's Disease
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
Zhejiang Provincial People's Hospital · Other
Who this trial is looking for
This trial is looking for patients with Alzheimer's disease. Participants will receive either a new type of surgery along with their usual medication or just their usual medication.
Are You a Good Fit for This Trial?
You may be able to join if
I am over 35 years old.
I have been diagnosed with Alzheimer's disease.
I have a MMSE or MOCA score of 26 or less.
I or my family member have signed an informed consent form.
You may not be able to join if
I cannot cooperate with a lumbar puncture.
I have cognitive impairment due to certain infections or diseases.
I have significant organ dysfunction.
I have coagulation disorders or contraindications to surgery.
I cannot fully cooperate with follow-up visits.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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…
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
Trial Locations
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City
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Status
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;
*…
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.
Contacts
No contact information available.
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