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This study is a randomized, double-blind, placebo-controlled phase 3 design aimed at further verifying the safety and efficacy of Wujia Yizhi granules for mild-to-moderate Alzheimer's dementia
This is a multi-center, randomized, double-blind, placebo-controlled phase 3 clinical trial targeting patients with mild-to-moderate Alzheimer's dementia (TCM differentiated as syndrome of deficiency of spleen and kidney). 570 subjects were recruited and randomly assigned to the experimental and placebo groups at a ratio of 2:1.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wujia Yizhi Granules | Experimental | Participants received Wujia Yizhi Granules 6g ,BID,once in the morning and once in the evening, at an interval of more than 8 hours, for up tp 12 months. |
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| Placebo | Placebo Comparator | Participants received Wujia Yizhi granules simulator 6g ,BID,once in the morning and once in the evening, at an interval of more than 8 hours, for up tp 12 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wujia Yizhi granules | Drug | Drug: Wujia Yizhi granuless |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to endpoint in Alzheimer's dementia Assessment Scale-Cognitive subscore (ADAS-Cog12). | The Alzheimer's Disease Assessment Scale - Cognitive Scale (ADAS-Cog12) is used to assess the cognitive function level of AD subjects. The ADAS-Cog12 score range is 0-75 points, and the higher the score on the scale, the more severe the cognitive impairment. | Change from Baseline to Month 12 |
| Change from baseline to endpoint in Clinical Dementia Rating-Sum of Boxes (CDR-SB). | The Alzheimer's Disease Assessment Scale - Cognitive Scale (CDR-SB) is used to assess the cognitive function level of AD subjects. The CDR-SB score range is 0-3 points, and the higher the score on the scale, the more severe the cognitive impairment. | Change from Baseline to Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to endpoint in ADAS-Cog12. | The Alzheimer's Disease Assessment Scale - Cognitive Scale (ADAS-Cog12) is used to assess the cognitive function level of AD subjects. The ADAS-Cog12 score range is 0-75 points, and the higher the score on the scale, the more severe the cognitive impairment. | Change from Baseline to month 3, 6, and 9 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lin song | Contact | 028-81258178 | 022516@cnkh.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiaochun Chen, Medical Doctor | Fujian Medical University Affiliated Union Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Medical University Affiliated Union Hospital | Recruiting | Fuzhou | Fujian | 350000 | China |
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| Placebo |
| Drug |
Placebo |
|
| Change from baseline to endpoint in CDR-SB. | The Alzheimer's Disease Assessment Scale - Cognitive Scale (CDR-SB) is used to assess the cognitive function level of AD subjects. The CDR-SB score range is 0-3 points, and the higher the score on the scale, the more severe the cognitive impairment. | Change from Baseline to month 3, 6, and 9 |
| Change from baseline to endpoint in he Alzheimer's dementia Cooperative Study-Activities of Daily Living (ADCS-ADL) scale. | The Alzheimer's Disease Collaborative Study Group - Activities of Daily Living Scale (ADCS-ADL) is used to evaluate the daily living abilities of AD subjects. The score range of ADCS-ADL is from 0 to 78, with higher numbers indicating better daily functioning. | Change from Baseline to month 3, 6, 9 and 12 |
| Change from baseline to endpoint in Mini-Mental State Examination (MMSE). | The Simple Intelligent State Examination Scale (MMSE) has a total of 19 items, with scores ranging from 0 to 30. In clinical practice, the diagnostic threshold is usually adjusted based on educational level, with university ≤ 26 points, middle school ≤ 24 points, primary school ≤ 23 points, and illiteracy ≤ 22 points, indicating dementia. | Change from Baseline to month 3, 6, 9 and 12 |
| Change from baseline to endpoint in Neuropsychiatric Inventory (NPI). | The Neuropsychiatric Inventory (NPI) includes a total of 12 items in 10 behavioral domains and 2 autonomic nervous system domains, with a score range of 0-144. The caregiver distress rating is 0-60, where 0 represents the best, and the higher the score, the higher the level of distress. | Change from Baseline to month 3, 6, 9 and 12 |
| Change from baseline to endpoint in Traditional Chinese Medicine Syndrome Score | TCM syndrome scale was used to evaluate the changes of TCM symptoms and signs before and after treatment. | Change from Baseline to month 3, 6, 9 and 12 |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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