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)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Wujia Yizhi granules, Placebo.
- Who it may be relevant to
- Registry conditions: Alzheimer's Dementia. Basic parameters: 50 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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).
Overview
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
Detailed description
This is a multi-center, randomized, double-blind, placebo-controlled phase 3 clinical trial targeting patients with mild-to-moderate Alzheimer's dementia (TCM differentiated as syndrome of deficiency of spleen and kidney). 570 subjects were recruited and randomly assigned to the experimental and placebo groups at a ratio of 2:1.
Interventions
- Drug Wujia Yizhi granules
Drug: Wujia Yizhi granuless - Drug Placebo
Placebo
Primary outcome measures
- Change from baseline to endpoint in Alzheimer's dementia Assessment Scale-Cognitive subscore (ADAS-Cog12). [Time frame: Change from Baseline to Month 12]
- Change from baseline to endpoint in Clinical Dementia Rating-Sum of Boxes (CDR-SB). [Time frame: Change from Baseline to Month 12]
Secondary outcome measures (6)
- Change from baseline to endpoint in ADAS-Cog12. [Time frame: Change from Baseline to month 3, 6, and 9]
- Change from baseline to endpoint in CDR-SB. [Time frame: Change from Baseline to month 3, 6, and 9]
- Change from baseline to endpoint in he Alzheimer's dementia Cooperative Study-Activities of Daily Living (ADCS-ADL) scale. [Time frame: Change from Baseline to month 3, 6, 9 and 12]
- Change from baseline to endpoint in Mini-Mental State Examination (MMSE). [Time frame: Change from Baseline to month 3, 6, 9 and 12]
- Change from baseline to endpoint in Neuropsychiatric Inventory (NPI). [Time frame: Change from Baseline to month 3, 6, 9 and 12]
- Change from baseline to endpoint in Traditional Chinese Medicine Syndrome Score [Time frame: Change from Baseline to month 3, 6, 9 and 12]
Eligibility criteria
Inclusion criteria
- 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 。
Exclusion criteria
- 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.
- HAMA score ≥ 14 points.
- Participants were taking antidepressants, anxieties, and antipsychotic drugs during screening.
- HIS score ≥ 4 points..
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Fujian Medical University Affiliated Union Hospital — Fuzhou
Identifiers
NCT: NCT06534723 · KH110-60101