Alzheimer's Disease(AD)SGB-ADNCT07351773
Ultrasound-Guided Stellate Ganglion Block for Alzheimer's Disease
A study testing Ultrasound-Guided Stellate Ganglion Block, Memantine hydrochloride and Donepezil hydrochloride in people with Alzheimer's Disease(AD) and Cognitive Dysfunction, run by Taizhou Second People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Alzheimer's Disease(AD), Cognitive Dysfunction
- What is being tested?
- Ultrasound-Guided Stellate Ganglion Block, Memantine hydrochloride and Donepezil hydrochloride
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 26 Jan 2025to 29 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
Read more
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
Read the 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.
- Conditions
- Alzheimer's Disease(AD), Cognitive Dysfunction
- Being tested
- Ultrasound-Guided Stellate Ganglion Block, Memantine hydrochloride, Donepezil hydrochloride
- 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
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-Guided Stellate Ganglion BlockProcedure or surgery
Also called SGB
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.
Memantine hydrochlorideDrug
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 hydrochlorideDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Memantine hydrochloride; Drug: Donepezil hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Periprocedural (Day 1 through Day 20): during each stellate ganglion block session and within 30 minutes after each session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start26 Jan 2025
- Primary completion29 Jun 2025
- Study completion29 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's Disease(AD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, parallel-group trial comparing ultrasound-guided stellate ganglion block plus standard drug treatment versus standard drug treatment alone.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taizhou Second People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Taizhou Municipal Bureau of Science and Technology
- Responsible party
- Principal investigator, Yanan Ge, Taizhou Second People's Hospital
- Investigators
- Yanan Ge, Principal investigator, Taizhou Second People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07351773
- Sponsor's protocol ID
- TZYE-KY-2024-003
- Other IDs
- 24ywb104
- Acronym
- SGB-AD
- Status last verified
- Jan 2026
- First submitted
- 30 Dec 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autonomic Neuromodulation With Ultrasound-Guided Stellate Ganglion Block in Alzheimer's Disease: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07351773
- Acronym / sponsor ID
- SGB-AD / TZYE-KY-2024-003
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Taizhou Second People's HospitalUniversity, hospital or other
- Collaborators
- Taizhou Municipal Bureau of Science and Technology
- Study start
- 26 Jan 2025 (actual)
- Primary completion
- 29 Jun 2025 (actual)
- Study completion
- 29 Nov 2025 (actual)
- First posted
- 20 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, parallel-group trial comparing ultrasound-guided stellate ganglion block plus standard drug treatment versus standard drug treatment alone.
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-Guided SGB Plus Standard Drug Treatment | Experimental | Procedure: Ultrasound-Guided Stellate Ganglion Block, Drug: Memantine hydrochloride, Drug: Donepezil hydrochlorideParticipants 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. |
| Standard Drug Treatment Alone | Active comparator | Drug: Memantine hydrochloride, Drug: Donepezil hydrochlorideParticipants 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. |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound-Guided Stellate Ganglion BlockAlso: SGBUltrasound-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. | Procedure or surgery | Ultrasound-Guided SGB Plus Standard Drug Treatment |
| Memantine hydrochlorideBackground 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 | Standard Drug Treatment Alone, Ultrasound-Guided SGB Plus Standard Drug Treatment |
| Donepezil hydrochlorideBackground 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. | Drug | Standard Drug Treatment Alone, Ultrasound-Guided SGB Plus Standard Drug Treatment |
Primary outcome
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.
5 secondary outcomes
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: No. 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.
Related trials for Alzheimer's Disease(AD)
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
Active, not recruitingPhase 2
A Study to Evaluate the Safety and Biomarker Effects of RO7269162 in Participants at Risk for or at the Prodromal Stage of Alzheimer's Disease (AD)
Alzheimer's Disease
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingObservational study
Community-based Screening for Alzheimer's Disease
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
RecruitingObservational study
InRAD Observational Study
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yanan Ge principal investigator
Taizhou Second People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-Guided Stellate Ganglion Block, Memantine hydrochloride and Donepezil hydrochloride in people with Alzheimer's Disease(AD) and Cognitive Dysfunction, run by Taizhou Second People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.