Testing Wujia Yizhi Granules for Mild-to-Moderate Alzheimer's Dementia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 3 clinical trial is a multi-center, randomized, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of Wujia Yizhi granules in patients with mild-to-moderate Alzheimer's dementia, specifically those classified under the syndrome of deficiency of spleen and kidney. A total of 570 subjects will be recruited and randomly assigned to receive either the experimental treatment or a placebo in a 2:1 ratio. The study aims to provide further evidence on the effectiveness of this traditional Chinese medicine approach for Alzheimer's patients.

Why it matters

Who can join: the full rules

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..

Where it's running

• Fujian Medical University Affiliated Union Hospital
  Fuzhou, Fujian, China Recruiting

Study contacts

• Principal investigator: Xiaochun Chen, Medical Doctor — Fujian Medical University Affiliated Union Hospital
• Study coordinator: Lin song
• Email: 022516@cnkh.com
• Phone: 028-81258178

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.