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Wujia Yizhi Granules in mild-to-moderate Alzheimer's dementia
NCT06534723Phase 3
Key facts
- Status
- Recruiting
- Start
- Aug 2024
- Primary completion
- Aug 2026
- Countries
- 1
- Modality
- Botanical Extract
- Drugs
- Wujia Yizhi Granules
- Conditions
- Alzheimer's disease (AD)
01
Overview
Phase 3, randomised, double-blind trial in Alzheimer's disease (AD) comparing Wujia Yizhi Granules with Placebo (2 arms). Primary endpoints: Alzheimer's Disease Assessment Scale-Cognitive Subscale at 12 months and Clinical Dementia Rating-Sum of Boxes at 12 months. Started Aug 2024; status: recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Wujia Yizhi Granules
Experimental arm receiving Wujia Yizhi Granules 6g BID for 12 months
Placebo
Placebo arm receiving Wujia Yizhi granules simulator 6g BID for 12 months
03
Who it enrols
Adults aged 50-80 with mild-to-moderate Alzheimer's disease (MMSE 11-26, CDR-GS 1-2) with TCM syndrome of deficiency of spleen and kidney, with evidence of beta-amyloid deposition, excluding those with other types of dementia, psychiatric disorders, epilepsy, or taking psychotropic medications
04
Endpoints
Primary
Alzheimer's Disease Assessment Scale-Cognitive Subscale
Clinical Dementia Rating-Sum of Boxes
Secondary
Alzheimer's Disease Assessment Scale-Cognitive Subscale
Clinical Dementia Rating-Sum of Boxes
Alzheimer's Disease Cooperative Study-Activities of Daily Living
Mini-Mental State Examination
Neuropsychiatric Inventory
Traditional Chinese Medicine Syndrome Score
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