Ultrasound-Guided Stellate Ganglion Block for Alzheimer's Disease

NCT07351773 | Completed

• 2 other identifiers: TZYE-KY-2024-00324ywb104
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Alzheimer's Disease(AD); Cognitive Dysfunction

Keywords

Stellate Ganglion Block; Ultrasound-Guided; Autonomic Nervous System; Cognition; Mini-Mental State Examination; Randomized Controlled Trial; Quality of Life; Anxiety; Depression; Instrumental Activities of Daily Living

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Zung Self-Rating Anxiety Scale (SAS) Standard Score

  Baseline; Day 20 (end of treatment course); and 1, 3, and 6 months after treatment completion.

• Zung Self-Rating Depression Scale (SDS) Standard Score

  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

  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

  Baseline; Day 20 (end of treatment course); and 1, 3, and 6 months after treatment completion.

• Procedure-Related Adverse Events

  Periprocedural (Day 1 through Day 20): during each stellate ganglion block session and within 30 minutes after each session.

Study Arms (2)

Ultrasound-Guided SGB Plus Standard Drug Treatment

EXPERIMENTAL

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; Drug: Memantine hydrochloride; Drug: Donepezil hydrochloride

Standard Drug Treatment Alone

ACTIVE COMPARATOR

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; Drug: Donepezil hydrochloride

Interventions

Ultrasound-Guided Stellate Ganglion Block PROCEDURE

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.

Also known as: SGB

Ultrasound-Guided SGB Plus Standard Drug Treatment

Memantine hydrochloride DRUG

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.

Standard Drug Treatment Alone; Ultrasound-Guided SGB Plus Standard Drug Treatment

Donepezil hydrochloride DRUG

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.

Standard Drug Treatment Alone; Ultrasound-Guided SGB Plus Standard Drug Treatment

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Taizhou Second People's Hospital: lead
• Taizhou Municipal Bureau of Science and Technology: collaborator

Study Sites (1)

Taizhou Second People's Hospital

Taizhou, Zhejiang, 317200, China

Location

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction; Anxiety Disorders; Depression

Interventions

Memantine; Donepezil

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Amantadine; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Officials

• Yanan Ge

  Taizhou Second People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors were blinded to group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Model Details: Randomized, parallel-group trial comparing ultrasound-guided stellate ganglion block plus standard drug treatment versus standard drug treatment alone.

Study Record Dates

• First Submitted: December 30, 2025
• First Posted: January 20, 2026
• Study Start: January 26, 2025
• Primary Completion: June 29, 2025
• Study Completion: November 29, 2025
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)