Phase 3 Clinical Trial of Wujia Yizhi Granules in the Treatment of Mild-to-moderate Alzheimer's Dementia (Syndrome of Deficiency of Spleen and Kidney)
NCT Number: NCT06534723
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Alzheimer's Dementia
Interventions: DRUG: Wujia Yizhi granules|DRUG: Placebo
Sponsor: Sichuan Jishengtang Pharmaceutical Co., Ltd.
Sex: ALL
Age: OLDER_ADULT
Enrollment: 570
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-28
Completion Date: 2026-12-01

Summary:
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

Primary Outcome Measures: 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
Secondary Outcome Measures: 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|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