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)

NCT06534723 | Recruiting Phase 3

• 1 other identifier: KH110-60101
• Study Type: interventional
• Target: 570
• Locations: 1 country
• Sites: 1

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

Conditions

Alzheimer's Dementia

Outcome Measures

Primary Outcomes (2)

• 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 Month 12

• 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 Month 12

Secondary Outcomes (6)

• Change from baseline to endpoint in ADAS-Cog12.

  Change from Baseline to month 3, 6, and 9

• Change from baseline to endpoint in CDR-SB.

  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.

  Change from Baseline to month 3, 6, 9 and 12

• Change from baseline to endpoint in Mini-Mental State Examination (MMSE).

  Change from Baseline to month 3, 6, 9 and 12

• Change from baseline to endpoint in Neuropsychiatric Inventory (NPI).

  Change from Baseline to month 3, 6, 9 and 12

Study Arms (2)

Wujia Yizhi Granules

EXPERIMENTAL

Participants received Wujia Yizhi Granules 6g ,BID,once in the morning and once in the evening, at an interval of more than 8 hours, for up tp 12 months.

Drug: Wujia Yizhi granules

Placebo

PLACEBO COMPARATOR

Participants received Wujia Yizhi granules simulator 6g ,BID,once in the morning and once in the evening, at an interval of more than 8 hours, for up tp 12 months.

Drug: Placebo

Interventions

Wujia Yizhi granules DRUG

Drug: Wujia Yizhi granuless

Wujia Yizhi Granules

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 。

You may not qualify if:

• 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..

Sponsors & Collaborators

• Sichuan Jishengtang Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Fujian Medical University Affiliated Union Hospital

Fuzhou, Fujian, 350000, China

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Xiaochun Chen, Medical Doctor

  Fujian Medical University Affiliated Union Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lin song

CONTACT

028-81258178; 022516@cnkh.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2024
• First Posted: August 2, 2024
• Study Start: August 20, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)