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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)

RecruitingPhase 3Ages 50 Years - 80 YearsAllSichuan Jishengtang Pharmaceutical Co., Ltd.
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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..
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What it tests

  • Wujia Yizhi granules
  • Placebo
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Where

1 site
Fujian Medical University Affiliated Union Hospital
Fuzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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