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)

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 criteriafor 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 participantslack previous pathological evidence or biomarkers of Alzheimer's dementia, they musthave evidence of β-amyloid deposition biomarkers during screening (PET with abnormalamyloid 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 diagnosisof 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) anddementia caused by folate, vitamin B12 deficiency, or any other reason; Existence ofconsciousness 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 duringscreening.

7. HIS score ≥ 4 points..