Ultrasound-Guided Stellate Ganglion Block for Alzheimer's Disease

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

Interventions

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.

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.

Sponsors & Collaborators

• Taizhou Municipal Bureau of Science and Technology

  collaborator UNKNOWN

• Taizhou Second People's Hospital

  lead OTHER

Principal Investigators

• Yanan Ge · Taizhou Second People's Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

55 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-01-26

Primary Completion

2025-06-29

Completion

2025-11-29

Countries

• China

Study Locations