The main purpose of this study is to evaluate the safety and efficacy of Octohydroaminoacridine Succinate tablets and find the optimal dose in patients with mild to moderate Alzheimer's Disease.
The purpose of this study is a preliminary assessment of the Octohydroaminoacridine Succinate tablets in the treatment of mild to moderate Alzheimer's disease and explore the efficacy and safety of the best dose. The 288 patients were randomly assigned to four groups: high dose (4mg / time), moderate dose (2mg / time), low dose (1mg / time) and the placebo group, including four weeks of the trial screening period following 16 weeks double-blind treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
288
1mg, tid
1st-2nd week, 1mg, tid 3rd -16th week, 2mg, tid
1st-2nd week, 1mg, tid, 3rd -4th week, 2mg, tid, 5th-16th week, 4mg, tid
Guangzhou Brain Hospital
Guangzhou, Guangdong, China
RECRUITINGAffiliated Hospital of Guilin Medical University
Guilin, Guangxi, China
RECRUITINGAlzheimer's Disease Assessment Scale - Cognitive Subscale
Time frame: 20weeks
Clinician's Interview Based Impression of Change, plus caregiver input
Time frame: 20weeks
Activities of Daily Living:Activities of Daily Living Scale(ADL)
Time frame: 20weeks
Mental behavior: neuropsychiatric questionnaire (NPI)
Time frame: 20weeks
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0mg, tid
Hebei mental health center
Baoding, Hebei, China
RECRUITINGJiangsu Province Hospital
Nanjing, Jiangsu, China
RECRUITINGThe first Affiliated Hospital of Jilin University
Changchun, Jilin, China
RECRUITINGFirst Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
RECRUITINGThe First Affiliated Hospital of Medical School of Zhejiang University
Hangzhou, Zhejiang, China
RECRUITINGBeijing HuiLongGuan Hospital
Beijing, China
RECRUITINGBeijing Shijitan Hospital, EMU
Beijing, China
RECRUITINGShanghai Changzheng Hospital
Shanghai, China
RECRUITING...and 3 more locations