Health TrialsbyHealthPanel

Deep Cervical Lymphovenous Anastomosis for Moderate Alzheimer's Disease

ConditionAlzheimer's Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-80
SponsorSouthwest Hospital, China

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Deep cervical lymphovenous anastomosis (LVA)

    Procedure/Surgery

    A microsurgical lymphatic drainage procedure performed under operative microscope with ICG lymphography tracing. Bilateral deep cervical lymphovenous anastomosis is conducted to improve cerebral lymphatic clearance in patients with moderate Alzheimer's disease.

  • Routine Treatment

    Other intervention

    Participants receive only standard routine drug treatment for moderate Alzheimer's disease, with no surgical procedure performed.

Treatment groups

296 Participants
are divided into 2 treatment groups
Group A: Intervention Group (Surgery plus routine treatment)Experimental treatment 2 interventions
Group B: Control Group (Routine treatment only)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in CDR-SB score from baseline to 12 months after randomization

Change of Clinical Dementia Rating-Sum of Boxes (CDR-SB) score at 12 months compared with baseline, to evaluate overall cognitive and functional status of patients with moderate Alzheimer's disease.

Time frame
12 months after randomization

Secondary outcomes

1

Change in CDR-SB score at 1 month and 6 months after randomization

Serial changes of CDR-SB score at 1 month and 6 months post randomization.

Time frame
1 month, 6 months after randomization
2

Change in MMSE score

Change of Mini-Mental State Examination (MMSE) score reflecting general cognitive function.

Time frame
1 month, 6 months, 12 months after randomization
3

Change in Zarit Burden Interview (ZBI) score

Change of caregiver burden assessed by Zarit Burden Interview scale.

Time frame
1 month, 6 months, 12 months after randomization
4

Change in Aβ-PET Centiloid value

Variation of cerebral amyloid-beta deposition measured by Aβ-PET imaging.

Time frame
12 months after randomization

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Southwest Hospital, China

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: