Clinical trial NCT06534723: 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)
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).
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Alzheimer's Dementia
Lead sponsor: Chengdu Kanghong Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-08-02
Enrollment: 570
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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..

Primary outcomes:
measure: Change from baseline to endpoint in Alzheimer's dementia Assessment Scale-Cognitive subscore (ADAS-Cog12).
timeFrame: Change from Baseline to Month 12
measure: Change from baseline to endpoint in Clinical Dementia Rating-Sum of Boxes (CDR-SB).
timeFrame: Change from Baseline to Month 12
Secondary outcomes:
measure: Change from baseline to endpoint in ADAS-Cog12.
timeFrame: Change from Baseline to month 3, 6, and 9
measure: Change from baseline to endpoint in CDR-SB.
timeFrame: Change from Baseline to month 3, 6, and 9
measure: Change from baseline to endpoint in he Alzheimer's dementia Cooperative Study-Activities of Daily Living (ADCS-ADL) scale.
timeFrame: Change from Baseline to month 3, 6, 9 and 12
measure: Change from baseline to endpoint in Mini-Mental State Examination (MMSE).
timeFrame: Change from Baseline to month 3, 6, 9 and 12
measure: Change from baseline to endpoint in Neuropsychiatric Inventory (NPI).
timeFrame: Change from Baseline to month 3, 6, 9 and 12
measure: Change from baseline to endpoint in Traditional Chinese Medicine Syndrome Score
timeFrame: Change from Baseline to month 3, 6, 9 and 12
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Medical University Affiliated Union Hospital
state: Fujian
Study officials:
affiliation: Fujian Medical University Affiliated Union Hospital
name: Xiaochun Chen, Medical Doctor
role: PRINCIPAL_INVESTIGATOR
References: