Clinical Trial Details

NCT ID: NCT01569516
Date Last Changed: April 6, 2012


Research Study Summary

A clinical trial seeking patients for a research study for the treatment of Alzheimer's Disease

Research Study Title

A Phase II, Double Blind, Placebo-controlled, Randomized, Multi-Center, Parallel Group Dose Exploring Study to Evaluate the Efficacy and Safety of Octohydroaminoacridine Succinate Tablets in Patient With Mild to Moderate Alzheimer's Disease


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.

To Learn more

Recruitment Details

Both Male and Female
50 to 85 Years
Overall Status
Lead Sponsor
Changchun Huayang High-tech Co., Ltd
13 Months
Facility Type


Both Male and Female ages 50 Years to 85 Years

Inclusion Criteria:

  1. Clinical diagnosis of probable AD based on DSM-IV and the NINCDS-ADRDA criteria.

  2. Male/female patient aged between 50 and 85.

  3. mild to moderate probable AD :Middle school or above: 11 ≤MMSE ≤ 25, elementary school: 8 ≤ MMSE ≤ 20, illiteracy: 5 ≤ MMSE ≤ 16.

  4. CT or MRI scan excluding another structural brain disease in one year.

  5. Neurologic examination no significant abnormalities.

  6. Hachinski Ischemic Score < 4;Hamilton Depression Scale ≤10. Able to complete the test procedure, audio-visual and physical ability to act to complete the neuropsychological measure.

  7. Stable chaperone, more than 2 hours a day together with the patient or accumulated fewer than 14 hours per week.

  8. Informed consent of the patient (or legal representative) and of the caregiver agreeing to take part in the study.

Exclusion Criteria:

  1. Proven or clinically suspected other type of dementia such as vascular dementia, Lewy body dementia, Parkinson's disease, frontotemporal dementia, g - Jakob disease (spastic pseudo-sclerosis), normal pressure hydrocephalus etc.

  2. Sudden onset of early dementia or with gait disorders, seizures and behavioral changes.

  3. Clinical manifestations of focal neurological signs (hemiparesis, sensory loss, visual field defect) or early extrapyramidal tract signs.

  4. History of cerebrovascular disease and stroke.

  5. Serious lack of folic acid and VitB12, syphilis antibody positive or thyroid dysfunction.

  6. Mechanical intestinal obstruction patient ,Resting pulse less than 60,Severe liver or renal disease.

  7. Patients with mechanical intestinal obstruction.

  8. History of bone marrow transplantation.Mental illness, such as severe depression.

  9. Cognitive damage caused by alcohol or drug abuse. Disable to correctly evaluate the cognitive function.

  10. Critical condition, disable to make the exact evaluation of the efficacy and safety of new drug.

  11. Use of any agent for the treatment of dementia within 4 weeks of randomization.

  12. Be sensitive to ACHEI.

  13. Be sensitive to two or more foods/drugs.

  14. Use of another investigational agent within one months of screening.

Site Locations (13)

Country State City Zip Facility and Contact
China Guangdong Guangzhou Guangzhou Brain Hospital
Hui Li

Muni Tang, MD
Principal Investigator
China Guangxi Guilin Affiliated Hospital of Guilin Medical University
Wei Chen

Kaixiang Liu
Principal Investigator
China Hebei Baoding Hebei mental health center
Qinpu Jiang

Qinpu Jiang
Principal Investigator
China Jiangsu Nanjing Jiangsu Province Hospital
Tianping Li

Weixian Chen
Principal Investigator
China Jilin Changchun The first Affiliated Hospital of Jilin University
Fei Wang

Li Sun, MD
Principal Investigator
China Yunnan Kunming First Affiliated Hospital of Kunming Medical University
Jian Qin

Yan Bai
Principal Investigator
China Zhejiang Hangzhou The First Affiliated Hospital of Medical School of Zhejiang University
Benyan Luo

Benyan Luo
Principal Investigator
China Beijing Beijing HuiLongGuan Hospital
Guanghui Zhang

Lan Shang
Principal Investigator
China Beijing Beijing Shijitan Hospital, EMU
Shumei Wang

Jing Zhang
Principal Investigator
China Shanghai Shanghai
Huafang Li
86-21-64387250 ext. 3128

Shifu Xiao, MD
Principal Investigator

Xia Li, MD
China Shanghai Shanghai Changzheng Hospital
Zhongxin Zhao, MD

Zhongxin Zhao, MD
Principal Investigator

Liuqing Huang
China Shanghai Shanghai First People's Hospital
Xiaohua Li
86-21-63240090 ext. 6410

Xiaoping Wang
Principal Investigator
China Shanghai Shanghai Tenth People's hospital
Jie Yu

Xueyuan Liu
Principal Investigator


Huafang Li, MD
86-21-64387250 ext. 3128

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