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Clinical Trials in China / NCT06534723
Recruiting Phase 3

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)

NCT06534723 · tracked via the Priya Life Science China tracker
Sponsor
Sichuan Jishengtang Pharmaceutical Co., Ltd.
Phase
Phase 3
Started
2024-08-20
Last updated
2025-12-29

Condition(s) studied

Alzheimer's Dementia

Investigational drug(s) / intervention(s)

Wujia Yizhi granulesPlacebo

Wujia Yizhi granules: Drug: Wujia Yizhi granuless

Placebo: Placebo

Study 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

Eligibility

Sex
ALL
Min age
50 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: 1. Male or female, age range : 50 - 80 years old. 2. Informed consent signed and dated by patient or legal representative. 3. The participants are mild-to-moderate AD patients who meet the diagnostic criteria for AD proposed by the National Institute on Aging and the Alzheimer's Association (NIA-AA) in 2018 and have a disease course of more than 6 months. If participants lack previous pathological evidence or biomarkers of Alzheimer's dementia, they must have evidence of β-amyloid deposition biomarkers during screening (PET with abnormal amyloid deposition or low cerebrospinal fluid Aβ 42 and Aβ 42/Aβ 40 ratio). 4. MMSE score 11 to 26;CDR-GS score 1 to 2 。 Exclusion Criteria: 1. Participants with non AD induced memory and cognitive impairment, such as diagnosis of other types of dementia, including but not limited to mixed dementia (AD VaD), vascular dementia (VD), Parkinson's disease dementia (PDD), Lewy body dementia (DLB), Huntington's disease related dementia, frontotemporal lobe dementia (FTD), etc; Endocrine system disorders (such as thyroid diseases, parathyroid diseases) and dementia caused by folate, vitamin B12 deficiency, or any other reason; Existence of consciousness disorders, etc. 2. Participants have a history of epileptic seizures. 3. Participants are psychiatric patients, including but not limited to schizophrenia, affective schizophrenic disorder, bipolar disorder, or delirium. 4. HAMD-17 score ≥ 17 points. 5. HAMA score ≥ 14 points. 6. Participants were taking antidepressants, anxieties, and antipsychotic drugs during screening. 7. HIS score ≥ 4 points..

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Fujian Medical University Affiliated Union Hospital Fuzhou Fujian Recruiting

More Sichuan Jishengtang Pharmaceutical Co., Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06534723 on ClinicalTrials.gov ↗ ← All trials in China