Actively Recruiting
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)
Led by Sichuan Jishengtang Pharmaceutical Co., Ltd. · Updated on 2025-12-29
570
Participants Needed
1
Research Sites
119 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, age range: 50 - 80 years old
- Signed informed consent by patient or legal representative
- Diagnosis of mild-to-moderate Alzheimer's dementia meeting 2018 NIA-AA criteria with disease duration over 6 months
- Evidence of β-amyloid deposition biomarkers if no prior pathological or biomarker confirmation
- Mini-Mental State Examination (MMSE) score between 11 and 26
- Clinical Dementia Rating-Global Score (CDR-GS) score between 1 and 2
You will not qualify if you...
- Diagnosed with non-Alzheimer's dementia or other cognitive impairments like vascular dementia, Parkinson's disease dementia, Lewy body dementia, frontotemporal dementia, or dementia due to endocrine disorders or vitamin deficiencies
- History of epileptic seizures
- Psychiatric disorders including schizophrenia, bipolar disorder, or delirium
- Hamilton Depression Rating Scale (HAMD-17) score 17 or higher
- Hamilton Anxiety Rating Scale (HAMA) score 14 or higher
- Taking antidepressant, anxiolytic, or antipsychotic drugs at screening
- Hachinski Ischemic Score (HIS) 4 or higher
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fujian Medical University Affiliated Union Hospital
Fuzhou, Fujian, China, 350000
Actively Recruiting
Research Team
L
Lin song
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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