Deep Cervical Lymphatic Venous Anastomosis in the Treatment of Alzheimer's Disease: A Multicenter, Prospective, Open-label, Blinded-Endpoint, Randomized Controlled Trial (CLEAN-AD)
Status: Recruiting
Location: See all (9) locations...
Intervention Type: Other, Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This multicenter, prospective, open-label, blinded-endpoint, randomized controlled trial is to evaluate the efficacy and safety of deep cervical lymphatic venous anastomosis (DC-LVA) plus usual care versus usual care in reduing the score of clinical dementia rating-sum of boxes (CDR-SB) at 12 months in patients with moderate-to-severe Alzheimer's Disease (AD).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 80
Healthy Volunteers: f
View:
• Age 50-80 years, male or female.
• Diagnosed with AD according to NIA-AA criteria.
• Moderate-to-severe AD dementia, defined as Clinical Dementia Rating Scale Global Score (CDR-GS) ≥1.
• Mini-Mental State Examination (MMSE) score 10-20.
• The course of AD more than 6 months.
• If receiving an approved AD treatment, must be on a stable drug dose for at least 3 months prior to Baseline. AD Treatment-naïve subjects can be entered into the study.
• Have an identified caregiver (defined as a person able to support the subject for the duration of the study and who spends at least 8 hours per week with the subject). The caregiver must accompany with the participant at all study follow-up visits.
• Signed informed consent (from the participant or their relative, and the caregiver).
Locations
Other Locations
China
Beijing Tiantan Hopital, Capital Medical University
RECRUITING
Beijing
Dongguan Chashan Hospital
RECRUITING
Dongguan
Guangdong Second People's Hospital
RECRUITING
Guangdong
First Affiliated Hospital of Shandong First Medical University
ACTIVE_NOT_RECRUITING
Jinan
Shandong Provincial Public Health Clinical Center
RECRUITING
Jinan
Shandong Provincial Third Hospital
RECRUITING
Jinan
Jining First People's Hospital
RECRUITING
Jining
The First Affiliated Hospital of Ningbo University
RECRUITING
Ningbo
Zhengzhou Central Hospital
RECRUITING
Zhengzhou
Contact Information
Primary
Yuesong Pan
yuesongpan@aliyun.com
0086-010-59975807
Backup
Yilong Wang
yilong528@aliyun.com
0086-010-67092222
Time Frame
Start Date:2026-03-13
Estimated Completion Date:2029-11-30
Participants
Target number of participants:376
Treatments
Experimental: DC-LVA treatment plus usual care
The intervention requires to perform bilateral deep cervical lymphatic venous anastomosis (DC-LVA). The usual care includes patients who were not using or were currently using medications for improving cognitive function.
Active_comparator: Usual care
The usual care group includes patients who were not using or were currently using medications for improving cognitive function.