NCT07658430Not yet recruiting
Deep Cervical Lymphovenous Anastomosis for Moderate Alzheimer's Disease
The Efficacy and Safety of Deep Cervical LYMphatic-Venous Anastomosis for Moderate Alzheimer's Disease: A Multicenter, Prospective, Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 22 Jun 2026
Brief summary (registry, in English)
This is a multicenter, prospective, open-label, endpoint-blinded randomized controlled clinical study. We aim to evaluate the safety and efficacy of deep cervical lymphovenous anastomosis (LVA) combined with routine treatment for patients with moderate Alzheimer's disease, compared with routine treatment alone. A total of 296 eligible participants aged 50 to 80 years with moderate Alzheimer's disease will be enrolled and randomly divided into two groups at a 1:1 ratio. One group will receive deep cervical lymphovenous anastomosis plus standard routine treatment, while the other group will only receive standard routine treatment for Alzheimer's disease. All participants will be followed up for 12 months after randomization. We will assess cognitive function using MMSE and CDR-SB scales, evaluate caregiver burden via ZBI scale, and detect changes in Alzheimer's disease related biomarkers including blood amyloid-beta and tau protein, as well as Aβ-PET imaging indicators. The main goal is to observe whether this surgical procedure can improve patients' neurological function and clear abnormal protein deposits in the brain, and confirm its long-term safety. This study strictly follows ethical principles. Every participant or their legal representative will sign a written informed consent before enrollment. During the whole study period, we will closely monitor all adverse events to ensure the safety of participants.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 296 (estimated)
- First submitted
- 13 Jun 2026
- Start date
- 1 Jul 2026
- Primary completion date
- 30 Jun 2028
- Lead sponsor
- Southwest Hospital, China
- Diseases
- Alzheimer disease
- NCT number
- NCT07658430
What you commit to
- Study type: Interventional
- Planned participants: 296
- From 1 Jul 2026 to the primary completion date, 30 Jun 2028
- 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.
Prior treatment
- Participation in other interventional clinical trials within 3 months before enrollment.
Other illness
- Severe cardiac, hepatic, renal, respiratory or hematopoietic system dysfunction unable to tolerate surgery or anesthesia.
- A history of intracranial surgery, severe craniocerebral trauma, stroke, brain tumor or other central nervous system diseases.
- Other types of dementia, including vascular dementia, frontotemporal dementia, Lewy body dementia, or mixed dementia.
- Psychiatric disorders requiring long-term medication that may affect cognitive assessment results.
- Contraindications for PET imaging or contrast agent allergy.
- Active infection, malignant tumor or severe wasting disease.
- Any other condition judged inappropriate for enrollment by the investigator.
Other
- Pregnancy or breastfeeding status.
- Poor compliance or inability to complete scheduled follow-up.
Who the study is looking for
- Aged 50 to 80 years old, male or female.
- Clinically diagnosed with moderate probable Alzheimer's disease according to the NIA-AA criteria.
- Baseline Mini-Mental State Examination (MMSE) score between 10 and 20 points.
- Clinical cognitive decline duration of at least 6 months.
- Stable routine anti-dementia drug treatment for more than 6 months without obvious clinical improvement.
- Able to complete neuropsychological scale assessments, blood biomarker detection and Aβ-PET examination.
- Have a reliable caregiver who can accompany follow-up visits and assist in completing evaluations.
- The participant or legal surrogate voluntarily signs the written informed consent.
Age in the registry: 50 years to 80 years · 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 |
|---|---|---|---|
| The First Affiliated Hospital of Army Medical University (Southwest Hospital) Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.