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| Name | Class |
|---|---|
| Shanghai Minimally Invasive Surgery Center | OTHER |
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The goal of this clinical trial is to learn if acupuncture works to treat mild-to-moderate Alzheimer's disease, as well as the difference of its effect in APOE e4 carriers and non-carriers. It will also learn about the safety of acupuncture.
Researchers will compare acupuncture to a placebo (sham acupuncture) to see if acupuncture works to relieve the cognitive impairment and improve the ability of daily living and the quality of life. In addition, the plasma and neuroimaging biomarkers will be included as objective indexes.
Participants will:
Experience acupuncture or sham acupuncture 3 times per week for 12 weeks, and receive a 52-week follow-up.
Visit the clinic at Week 12, Week 38 and Week 64 for checkups and tests.
This is a two-centre randomized controlled trial. A total of 176 participants with mild-to-moderate Alzheimer's disease, 88 APOE e4 carriers and 88 non-carriers, will be randomly assigned to either an acupuncture combined with donepezil group or a sham acupuncture combined with donepezil group with a ratio of 1:1. The main acupoints are DU 24, EX-HN 3, DU 20, EX-HN 1, GB 12, HT 7, KI 6, GB39. There will be 12 weeks of 3-session treatment for each participant, and a 52-week follow-up in total. The primary outcome is the change and effective rate from baseline in the ADAS-cog score measured at Week 12.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupuncture Treatment | Experimental | Participants in this group will receive acupuncture treatment in combination with donepezil for 12 weeks. |
|
| Sham Acupuncture Treatment | Active Comparator | Participants in this group will receive sham acupuncture treatment in combination with donepezil for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture | Other | The main acupoints are DU 24, EX-HN 3, DU 20, EX-HN 1, GB 12, HT 7, KI 6, GB39, and then selecting other acupoints according to TCM syndrome. There will be 12 weeks of 3-session treatment for each participant in total. |
| Measure | Description | Time Frame |
|---|---|---|
| Alzheimer's Disease Assessment Scale-cognition (ADAS-cog) | The maximum score of the ADAS-cog is 70 including 12 items. The questions in this scale contain word recall task, naming objects and fingers, following commands, constructional praxis, ideational praxis, orientation, word recognition task, remembering test directions, spoken language, word-finding difficulty, comprehension and attention. In general, a normal score for someone who does not have AD or another type of dementia is 5. The higher scores indicate higher degree of cognitive dysfunction. | Change from baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Alzheimer's Disease Assessment Scale-cognition (ADAS-cog) | The maximum score of the ADAS-cog is 70 including 12 items. The questions in this scale contain word recall task, naming objects and fingers, following commands, constructional praxis, ideational praxis, orientation, word recognition task, remembering test directions, spoken language, word-finding difficulty, comprehension and attention. In general, a normal score for someone who does not have AD or another type of dementia is 5. The higher scores indicate higher degree of cognitive dysfunction. |
| Measure | Description | Time Frame |
|---|---|---|
| Phosphorylated tau at threonine 181 (p-tau181) | Plasma p-tau181measured by Single Molecule Array (Simoa) as the plasma biomarker. | Change from baseline to Week 12 and Week 64 (Follow-up 2) |
| Cerebral Blood Flow (CBF) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yijun Zhan | Contact | +8618917699167 | jenniferzhan_lhzj@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yijun Zhan | Shanghai University of Traditional Chinese Medicine | Study Chair |
| Houguang Zhou | Huashan Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Longhua Hospital, Shanghai University of Traditional Chinese Medicine | Recruiting | Shanghai | 200032 | China |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| D000077265 | Donepezil |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D007189 | Indans |
| D007192 | Indenes |
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Streitberger placebo needle will be used as sham acupuncture method to mask the paticipants. The outcome assessors will also be blind to the grouping.
| Sham Acupuncture | Other | The Streitberger placebo needle will be used to simulate an acupuncture procedure without penetrating the skin. The main acupoints are DU 24, EX-HN 3, DU 20, EX-HN 1, GB 12, HT 7, KI 6, GB39, and then selecting other acupoints according to TCM syndrome. There will be 12 weeks of 3-session treatment for each participant in total. |
|
| Donepezil | Drug | Donepezil 5 mg will be given once daily before bed-time for 12 weeks. |
|
| Change from baseline to Week 38 (Follow-up 1) and Week 64 (Follow-up 2) |
| Alzheimer's Disease Cooperative Study-Activity of Daily Living (ADCS-ADL) | The maximum of the ADCS-ADL score is 54 containing 19 domains about assessment of basic and operational ability of daily living. The higher scores indicate higher ability of daily living. | Change from baseline to Week 12, Week 38 (Follow-up 1) and Week 64 (Follow-up 2) |
| Quality of Life-Alzheimer's Disease(QOL-AD) | The QOL-AD score includes 13 items about physical health, mental health, social and financial assessment, and quality of life. The total score ranges from 13 to 52. The higher scores indicate higher quality of life. | Change from baseline to Week 12, Week 38 (Follow-up 1) and Week 64 (Follow-up 2) |
CBF acquired by arterial spin labeling (ASL) magnetic resonance imaging (MRI) technique measures the blood flow condition of the whole brain.
| Change from baseline to Week 12 and Week 64 (Follow-up 2) |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |
| D011084 |
| Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |