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Completed

NCT Number: NCT07351773

Ultrasound-Guided Stellate Ganglion Block for Alzheimer's Disease

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

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Key information

Conditions

Alzheimer's Disease(AD) Alzheimer Disease Anxiety Disorders Behavior Behavioral Symptoms Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Depression Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

55 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taizhou Second People's Hospital

Taizhou, Zhejiang, 317200, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Other names: SGB

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.

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.

Primary outcomes

  1. Mini-Mental State Examination (MMSE) Total Score

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

    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.

Secondary outcomes

  1. Zung Self-Rating Anxiety Scale (SAS) Standard Score

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

    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.

  2. Zung Self-Rating Depression Scale (SDS) Standard Score

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

    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.

  3. Quality of Life in Alzheimer's Disease (QoL-AD) Total Score

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

    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.

  4. Lawton-Brody Instrumental Activities of Daily Living (IADL) Total Score

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

    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.

  5. Procedure-Related Adverse Events

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

    Number of participants with procedure-related adverse events occurring during the stellate ganglion block procedure or within 30 minutes after each session.

Sponsors and collaborators

Lead sponsor

Taizhou Second People's Hospital

Other

Collaborators

  • Taizhou Municipal Bureau of Science and Technology

Registry information

Official study title

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

Acronym: SGB-AD

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 20, 2026
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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