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)

Официальное название

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).

Обзор

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

Подробное описание

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.

Вмешательства

• Препарат Wujia Yizhi granules
  Drug: Wujia Yizhi granuless
• Препарат Placebo
  Placebo

Первичные конечные точки

• Change from baseline to endpoint in Alzheimer's dementia Assessment Scale-Cognitive subscore (ADAS-Cog12). [Срок оценки: Change from Baseline to Month 12]
• Change from baseline to endpoint in Clinical Dementia Rating-Sum of Boxes (CDR-SB). [Срок оценки: Change from Baseline to Month 12]

Вторичные конечные точки (6)

• Change from baseline to endpoint in ADAS-Cog12. [Срок оценки: Change from Baseline to month 3, 6, and 9]
• Change from baseline to endpoint in CDR-SB. [Срок оценки: 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. [Срок оценки: Change from Baseline to month 3, 6, 9 and 12]
• Change from baseline to endpoint in Mini-Mental State Examination (MMSE). [Срок оценки: Change from Baseline to month 3, 6, 9 and 12]
• Change from baseline to endpoint in Neuropsychiatric Inventory (NPI). [Срок оценки: Change from Baseline to month 3, 6, 9 and 12]
• Change from baseline to endpoint in Traditional Chinese Medicine Syndrome Score [Срок оценки: Change from Baseline to month 3, 6, 9 and 12]

Критерии участия

Критерии включения

• 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 。

Критерии исключения

• 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..

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Fujian Medical University Affiliated Union Hospital — Фучжоу

Идентификаторы

NCT: NCT06534723 · KH110-60101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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