Efficacy and Safety of Yangxue Qingnao Pills in the Treatment of Mild to Moderate Alzheimer's Disease

Yangxue Qingnao pills is a traditional Chinese herbal medicine, which is composed of Angelicae Sinensis Radix , Chuanxiong Rhizoma , Paeoniae Radix Alba, Rehmannia glutinosa, Uncaria macrophylla Wall, Caulis spatholobi, Spica Prunellae, Catsia tora Linn , Mater Margarita, Corydalis ambigua and Asarum sieboldii. The function of Yangxue Qingnao pills is nourishing blood and calming liver, promoting blood circulation and dredging collaterals in Chinese traditional medicine theory. This study is a 48-weeks, multicenter, randomized, double-blind, parallel controlled phase II trial being carried out in China. The study population includes mild to moderate Alzheimer's disease (planned a total of 216) aged 65-85 in both gender. Participants will be randomly allocated to Yangxue Qingnao pills high dose group (7.5 g per time,2 times per day) ; and Yangxue Qingnao pills low dose group (5 g per time,2 times per day), or placebo group for a 48-weeks double-blind treatment period. The primary outcome measure is change from baseline in the Alzheimer's Disease Assessment Scale- Cognition Subscale (ADAS-cog) and the clinical dementia rating scale. The secondary outcomes are changes from baseline in the Mini-Mental State Examination(MMSE), Alzheimer's Disease Cooperative Study-Activities of Daily Living scale (ADCS-ADL/24) and Neuropsychiatric Inventory. Besides, the blood biomarkers including Aβ42, Aβ40, T-tau, P-tau181, NfL, TOM1, IL-1R1,IL-1b, IL-6, IL-8, TNF-a, FB, FH, sCR1, MCP-1, eotaxin-1, Ach, ChEI and the hippocampal volume on MRI. Safety is being assessed by observing side effects and adverse reaction during the entire treatment period. Statistical analysis will be conducted according to per-protocol population and intend-to-treat population and the safety will be analyzed in safety set.