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| ID | Type | Description | Link |
|---|---|---|---|
| 24ywb104 | Other Grant/Funding Number | Taizhou Municipal Science and Technology Bureau |
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| Name | Class |
|---|---|
| Taizhou Municipal Bureau of Science and Technology | UNKNOWN |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yanan Ge | Taizhou Second People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taizhou Second People's Hospital | Taizhou | Zhejiang | 317200 | China |
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.
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D060825 | Cognitive Dysfunction |
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D008559 | Memantine |
| D000077265 | Donepezil |
| ID | Term |
|---|---|
| D000547 | Amantadine |
| D000218 | Adamantane |
| D001952 | Bridged-Ring Compounds |
| D006844 | Hydrocarbons, Cyclic |
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Randomized, parallel-group trial comparing ultrasound-guided stellate ganglion block plus standard drug treatment versus standard drug treatment alone.
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Outcome assessors were blinded to group assignment.
|
| 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. |
|
| 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. |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D007189 | Indans |
| D007192 | Indenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |