RecruitingPhase 3NCT06534723

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)

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).


Sponsor

Sichuan Jishengtang Pharmaceutical Co., Ltd.

Enrollment

570 participants

Start Date

Aug 20, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 50 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This Phase 3 study tests a traditional Chinese herbal medicine called Wujia Yizhi Granules in people with mild-to-moderate Alzheimer's disease. In Traditional Chinese Medicine, this formula is used to address a pattern called "deficiency of spleen and kidney." Researchers want to find out whether this herbal treatment can slow the progression of Alzheimer's symptoms — such as memory loss and daily functioning — compared to a placebo over a set period. **You may be eligible if...** - You are 50 to 80 years old - You have a confirmed diagnosis of Alzheimer's disease of mild-to-moderate severity (MMSE score 11–26, CDR-GS 1–2) - You have had symptoms for more than 6 months - If you lack prior biomarker testing, you have evidence of amyloid buildup in the brain from either a PET scan or cerebrospinal fluid test - You or your legal representative can provide informed consent **You may NOT be eligible if...** - Your memory problems are caused by something other than Alzheimer's (e.g., vascular dementia, Parkinson's, Lewy body disease, thyroid disease, vitamin deficiency) - You have a history of seizures - You have a psychiatric disorder (such as schizophrenia or bipolar disorder) - Your depression score (HAMD-17) is 17 or higher - You are currently taking antidepressants, anti-anxiety drugs, or antipsychotics Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGWujia Yizhi granules

Drug: Wujia Yizhi granuless

DRUGPlacebo

Placebo


Locations(1)

Fujian Medical University Affiliated Union Hospital

Fuzhou, Fujian, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06534723


Related Trials