Department of Neurology, General Hospital of Northern Theater Command
Shenyang, 110016, China
Location status: Recruiting
NCT Number: NCT07294885
Lymphaticovenous anastomosis (LVA) is a microsurgical technique that involves anastomosing fine lymphatic vessels with adjacent veins to reestablish lymphatic drainage pathways. It is used in the treatment of lymphedema-related conditions and is characterized by minimal invasiveness and rapid recovery. Based on findings from animal studies, some physicians in China have attempted deep cervical lymphatic-venous anastomosis to improve intracranial lymphatic drainage in patients with Alzheimer's disease (AD). Most studies, including those from our center, have observed early postoperative improvements in various domains such as mood, memory, executive function, and communication abilities in the majority of patients. However, these symptomatic improvements are not sustained. The reasons for the early improvements remain unclear. Are they due to enhanced lymphatic drainage resulting from the surgery itself, or are they attributable to other factors such as anesthetic effects, vascular release, or modulation of sympathetic nerves? Therefore, it is necessary to conduct a randomized controlled trial with a sham surgery group to clarify the causes of early clinical symptom improvements. Based on this, this project aims to carry out a prospective, single-center, randomized double-blind controlled study to evaluate whether the early symptomatic improvements following deep cervical LVA in AD patients are attributable to the surgical intervention itself or to other aspects of the procedure.
Interested in participating?
Request Info50 year–80 year
All sexes
Interventional
Not applicable
Shenyang, 110016, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
patients will receive deep cervical lymphaticovenous anastomosis
Time frame: 4±1 days
MoCA ranges from 0 to 30, with higher score meaning better outcome
Time frame: 4±1 days
MMSE ranges from 0 to 30, with higher score meaning better outcome
Time frame: 4±1 days
BI ranges from 0 to 100, with higher score meaning better outcome
Time frame: 4±1 days
CIBIC-plus ranges from 1 to 7, with higher score meaning worse outcome
Time frame: 90±7 days; 180±15 days; 270±20 days
MoCA ranges from 0 to 30, with higher score meaning better outcome
Time frame: 90±7 days; 180±15 days; 270±20 days
MMSE ranges from 0 to 30, with higher score meaning better outcome
Time frame: 90±7 days; 180±15 days; 270±20 days
BI ranges from 0 to 100, with higher score meaning better outcome
Time frame: 90±7 days; 180±15 days; 270±20 days
CIBIC-plus ranges from 1 to 7, with higher score meaning worse outcome
Time frame: Perioperative period
General Hospital of Shenyang Military Region
Other
Deep Cervical LymphatIc-Venous Anastomosis for Alzheimer's Disease (CLIVA-AD): a Prospective, Single-center, Randomized, Double Blinded Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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