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

A 12-month Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, 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).

This study is testing if Wujia Yizhi granules can help people with mild-to-moderate Alzheimer's dementia feel better compared to a placebo.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 570 (estimated)
• Ages: 50 Years to 80 Years
• Sex: All
• Sponsor: Chengdu Kanghong Pharmaceutical Group Co., Ltd. (industry)
• Locations: 1 site (Fuzhou, Fujian)
• Trial ID: NCT06534723 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are males and females aged 50 to 80 with mild-to-moderate Alzheimer's dementia and specific diagnostic criteria met.

Not a fit: Patients with other types of dementia or cognitive impairments not induced by Alzheimer's will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for managing symptoms of mild-to-moderate Alzheimer's dementia.

How similar studies have performed: While this approach is based on traditional Chinese medicine, similar studies have shown promise, but the specific use of Wujia Yizhi granules in this context is less established.

Eligibility criteria

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 this trial is running

Fuzhou, Fujian

• 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

Conditions: Alzheimer's Dementia