Ultrasound-Guided Stellate Ganglion Block for Alzheimer's Disease (SGB-AD)

Autonomic Neuromodulation With Ultrasound-Guided Stellate Ganglion Block in Alzheimer's Disease: A Randomized Controlled Trial

The goal of this clinical trial is to learn if ultrasound-guided stellate ganglion block (SGB), added to standard drug treatment, can improve thinking and memory in people with Alzheimer's disease. It will also learn about the safety of SGB.

The main questions this study aims to answer are:

Do people who receive SGB plus standard drug treatment have better global cognition, measured by the Mini-Mental State Examination (MMSE), 1 month after finishing the treatment course compared with people who receive standard drug treatment alone? How do anxiety, depression, quality of life, and ability to live independently change over 1 month, 3 months, and 6 months after treatment? What medical problems, if any, occur during or after SGB?

Researchers will compare two groups:

SGB plus standard drug treatment Standard drug treatment alone

Participants will:

Be randomly assigned to one of the two groups Receive the assigned treatment Complete study visits and assessments at baseline and at 1 month, 3 months, and 6 months after finishing the treatment course

Study Overview

• Status: Completed
• Conditions: Cognitive Dysfunction; Alzheimer's Disease(AD)
• Intervention / Treatment: Procedure: Ultrasound-Guided Stellate Ganglion Block; Drug: Memantine hydrochloride; Drug: Donepezil hydrochloride

Detailed Description

This is a randomized, parallel-group clinical trial in people with Alzheimer's disease. Participants are assigned to receive either ultrasound-guided stellate ganglion block (SGB) in addition to standard drug treatment or standard drug treatment alone. SGB is a procedure performed under ultrasound guidance in the neck region to temporarily block the stellate ganglion, which may influence autonomic nervous system activity.

The primary outcome is global cognition measured by the Mini-Mental State Examination (MMSE). The prespecified primary endpoint is 1 month after completion of the treatment course to capture a relatively stable post-treatment effect. Secondary outcomes include anxiety symptoms measured by the Zung Self-Rating Anxiety Scale (SAS), depressive symptoms measured by the Zung Self-Rating Depression Scale (SDS), quality of life measured by the Alzheimer's Disease Quality of Life scale (QoL-AD), and independent living ability measured by the Lawton-Brody Instrumental Activities of Daily Living scale (IADL). Outcomes are assessed at baseline and at 1 month, 3 months, and 6 months after completion of the treatment course.

Safety is evaluated by monitoring and recording adverse events related to the procedure and study participation throughout the treatment period and follow-up.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Taizhou, Zhejiang, China, 317200
      • Taizhou Second People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age 55 to 85 years.
2. Diagnosis of Alzheimer's disease (AD) based on the 2011 NIA-AA criteria.
3. Mild to moderate cognitive impairment assessed by the Mini-Mental State Examination (MMSE).
4. Ability to understand study procedures and provide written informed consent by the participant or a legally authorized representative.
5. Ability to complete scheduled follow-up assessments.

Exclusion Criteria:

1. Known allergy to lidocaine, coagulation disorders, or other contraindications to stellate ganglion block (SGB).
2. Severe cardiac, hepatic, or renal disease that could compromise safety.
3. Cranial surgery or major head trauma within the past 6 months.
4. Participation in other interventional trials that could affect study outcomes.
5. Cognitive impairment primarily due to other neurodegenerative diseases or psychiatric disorders.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ultrasound-Guided SGB Plus Standard Drug Treatment; Participants receive ultrasound-guided stellate ganglion block (SGB) in addition to standard-of-care Alzheimer's pharmacotherapy (memantine and/or donepezil) based on pre-existing treatment history; not all participants receive both medications.	Procedure: Ultrasound-Guided Stellate Ganglion Block; Ultrasound-guided stellate ganglion block performed according to a standardized protocol. The procedure was administered as a treatment course consisting of 10 sessions on alternate days.; Other Names: SGB; Drug: Memantine hydrochloride; Background standard-of-care pharmacotherapy for Alzheimer's disease. Participants continued their pre-enrollment memantine regimen as clinically indicated. Treatment could include memantine alone or in combination with donepezil. Dose and schedule were not standardized and were determined by the treating physician based on prior treatment history and routine clinical practice; all medication use and any changes were recorded.; Drug: Donepezil hydrochloride; Background standard-of-care pharmacotherapy for Alzheimer's disease. Participants continued their pre-enrollment donepezil regimen as clinically indicated. Treatment could include donepezil alone or in combination with memantine. Dose and schedule were not standardized and were determined by the treating physician based on prior treatment history and routine clinical practice; all medication use and any changes were recorded.
Active Comparator: Standard Drug Treatment Alone; Participants receive standard drug treatment alone without stellate ganglion block. Participants received standard-of-care Alzheimer's pharmacotherapy (memantine and/or donepezil) based on pre-existing treatment history; not all participants received both medications.	Drug: Memantine hydrochloride; Background standard-of-care pharmacotherapy for Alzheimer's disease. Participants continued their pre-enrollment memantine regimen as clinically indicated. Treatment could include memantine alone or in combination with donepezil. Dose and schedule were not standardized and were determined by the treating physician based on prior treatment history and routine clinical practice; all medication use and any changes were recorded.; Drug: Donepezil hydrochloride; Background standard-of-care pharmacotherapy for Alzheimer's disease. Participants continued their pre-enrollment donepezil regimen as clinically indicated. Treatment could include donepezil alone or in combination with memantine. Dose and schedule were not standardized and were determined by the treating physician based on prior treatment history and routine clinical practice; all medication use and any changes were recorded.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mini-Mental State Examination (MMSE) Total Score	Global cognition assessed using the Mini-Mental State Examination (MMSE). Total score range 0-30; higher scores indicate better cognitive function. The prespecified primary endpoint is 1 month after completion of the treatment course.	Baseline; Day 20 (end of treatment course); and 1, 3, and 6 months after completion of the treatment course.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Zung Self-Rating Anxiety Scale (SAS) Standard Score	Anxiety symptoms assessed using the Zung Self-Rating Anxiety Scale (SAS). The raw total score is multiplied by 1.25 and rounded to obtain a standard score. Score range 25-100; higher scores indicate more severe anxiety.	Baseline; Day 20 (end of treatment course); and 1, 3, and 6 months after treatment completion.
Zung Self-Rating Depression Scale (SDS) Standard Score	Depressive symptoms assessed using the Zung Self-Rating Depression Scale (SDS). The raw total score is multiplied by 1.25 and rounded to obtain a standard score. Score range 25-100; higher scores indicate more severe depressive symptoms.	Baseline; Day 20 (end of treatment course); and 1, 3, and 6 months after treatment completion.
Quality of Life in Alzheimer's Disease (QoL-AD) Total Score	Quality of life assessed using the Quality of Life in Alzheimer's Disease scale (QoL-AD). Total score range 13-52; higher scores indicate better quality of life.	Baseline; Day 20 (end of treatment course); and 1, 3, and 6 months after treatment completion.
Lawton-Brody Instrumental Activities of Daily Living (IADL) Total Score	Independent living ability assessed using the Lawton-Brody Instrumental Activities of Daily Living scale (IADL). Total score range 8-24; lower scores indicate poorer independence and greater care needs.	Baseline; Day 20 (end of treatment course); and 1, 3, and 6 months after treatment completion.
Procedure-Related Adverse Events	Number of participants with procedure-related adverse events occurring during the stellate ganglion block procedure or within 30 minutes after each session.	Periprocedural (Day 1 through Day 20): during each stellate ganglion block session and within 30 minutes after each session.

Collaborators and Investigators

• Sponsor: Taizhou Second People's Hospital
• Collaborators: Taizhou Municipal Bureau of Science and Technology
• Investigators: Principal Investigator: Yanan Ge, Taizhou Second People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2025
• Primary Completion (Actual): June 29, 2025
• Study Completion (Actual): November 29, 2025

Study Registration Dates

• First Submitted: December 30, 2025
• First Submitted That Met QC Criteria: January 10, 2026
• First Posted (Actual): January 20, 2026

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 17, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Depression; Quality of Life; Autonomic Nervous System; Anxiety; Randomized Controlled Trial; Cognition; Instrumental Activities of Daily Living; Mini-Mental State Examination; Stellate Ganglion Block; Ultrasound-Guided
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Neurocognitive Disorders; Cognition Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Behavior; Anxiety Disorders; Cognitive Dysfunction; Alzheimer Disease; Depression; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Hydrocarbons; Hydrocarbons, Cyclic; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Piperidines; Adamantane; Bridged-Ring Compounds; Amantadine; Indans; Indenes; Donepezil; Memantine
• Other Study ID Numbers: TZYE-KY-2024-003; 24ywb104 (Other Grant/Funding Number: Taizhou Municipal Science and Technology Bureau)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared because the dataset contains sensitive clinical information, and public or external sharing is not permitted under the informed consent, ethics approval requirements, and institutional policies. To protect participant privacy and confidentiality, only aggregated, de-identified results will be reported.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No