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
Male or female, age range : 50 - 80 years old.
Informed consent signed and dated by patient or legal representative.
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).
MMSE score 11 to 26;CDR-GS score 1 to 2 。
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.
Participants have a history of epileptic seizures.
Participants are psychiatric patients, including but not limited to schizophrenia, affective schizophrenic disorder, bipolar disorder, or delirium.
HAMD-17 score ≥ 17 points.
Parallel
Wujia Yizhi granules
DrugDrug: Wujia Yizhi granuless
Placebo
DrugPlacebo
Change from baseline to endpoint in Alzheimer's dementia Assessment Scale-Cognitive subscore (ADAS-Cog12).
The Alzheimer's Disease Assessment Scale - Cognitive Scale (ADAS-Cog12) is used to assess the cognitive function level of AD subjects. The ADAS-Cog12 score range is 0-75 points, and the higher the score on the scale, the more severe the cognitive impairment.
Change from baseline to endpoint in Clinical Dementia Rating-Sum of Boxes (CDR-SB).
The Alzheimer's Disease Assessment Scale - Cognitive Scale (CDR-SB) is used to assess the cognitive function level of AD subjects. The CDR-SB score range is 0-3 points, and the higher the score on the scale, the more severe the cognitive impairment.
Change from baseline to endpoint in ADAS-Cog12.
The Alzheimer's Disease Assessment Scale - Cognitive Scale (ADAS-Cog12) is used to assess the cognitive function level of AD subjects. The ADAS-Cog12 score range is 0-75 points, and the higher the score on the scale, the more severe the cognitive impairment.
Change from baseline to endpoint in CDR-SB.
The Alzheimer's Disease Assessment Scale - Cognitive Scale (CDR-SB) is used to assess the cognitive function level of AD subjects. The CDR-SB score range is 0-3 points, and the higher the score on the scale, the more severe the cognitive impairment.
Change from baseline to endpoint in he Alzheimer's dementia Cooperative Study-Activities of Daily Living (ADCS-ADL) scale.
The Alzheimer's Disease Collaborative Study Group - Activities of Daily Living Scale (ADCS-ADL) is used to evaluate the daily living abilities of AD subjects. The score range of ADCS-ADL is from 0 to 78, with higher numbers indicating better daily functioning.
Change from baseline to endpoint in Mini-Mental State Examination (MMSE).
The Simple Intelligent State Examination Scale (MMSE) has a total of 19 items, with scores ranging from 0 to 30. In clinical practice, the diagnostic threshold is usually adjusted based on educational level, with university ≤ 26 points, middle school ≤ 24 points, primary school ≤ 23 points, and illiteracy ≤ 22 points, indicating dementia.
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