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)

Launched by SICHUAN JISHENGTANG PHARMACEUTICAL CO., LTD. · Aug 1, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called Wujia Yizhi Granules for people with mild to moderate Alzheimer's dementia. The goal is to see if this herbal remedy is safe and effective in helping those who have been diagnosed with this condition. The trial is currently looking for participants aged between 50 and 80 years old who have been experiencing symptoms of Alzheimer's for more than six months. To qualify, participants should have certain scores on memory tests that show they have mild to moderate dementia.

If you or someone you know fits this description and is interested in participating, you can expect to take part in a double-blind study, meaning neither you nor the researchers will know if you are receiving the actual treatment or a placebo (a harmless dummy treatment). This helps ensure the results are fair and unbiased. Participants will be closely monitored throughout the trial to assess the safety and effectiveness of the treatment. It's important to note that individuals with other types of dementia or specific health issues, like psychiatric disorders, won't be eligible for this study.

Gender

ALL

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..