Back to resultsStudy of Octohydroaminoacridine Succinate Tablets in Patients With Alzheimer's Disease
Primary Purpose
Alzheimer's Disease
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Octohydroaminoacridine Succinate Tablets
Octohydroaminoacridine Succinate Tablets
Octohydroaminoacridine succinate Tablets
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer's Disease focused on measuring Alzheimer's Disease, Octohydroaminoacridine Succinate
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of probable AD based on DSM-IV and the NINCDS-ADRDA criteria.
- Male/female patient aged between 50 and 85.
- mild to moderate probable AD ：Middle school or above: 11 ≤MMSE ≤ 25, elementary school: 8 ≤ MMSE ≤ 20, illiteracy: 5 ≤ MMSE ≤ 16.
- CT or MRI scan excluding another structural brain disease in one year.
- Neurologic examination no significant abnormalities.
- 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.
- Stable chaperone, more than 2 hours a day together with the patient or accumulated fewer than 14 hours per week.
- Informed consent of the patient (or legal representative) and of the caregiver agreeing to take part in the study.
Exclusion Criteria:
- 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.
- Sudden onset of early dementia or with gait disorders, seizures and behavioral changes.
- Clinical manifestations of focal neurological signs (hemiparesis, sensory loss, visual field defect) or early extrapyramidal tract signs.
- History of cerebrovascular disease and stroke.
- Serious lack of folic acid and VitB12, syphilis antibody positive or thyroid dysfunction.
- Mechanical intestinal obstruction patient ,Resting pulse less than 60,Severe liver or renal disease.
- Patients with mechanical intestinal obstruction.
- History of bone marrow transplantation.Mental illness, such as severe depression.
- Cognitive damage caused by alcohol or drug abuse. Disable to correctly evaluate the cognitive function.
- Critical condition, disable to make the exact evaluation of the efficacy and safety of new drug.
- Use of any agent for the treatment of dementia within 4 weeks of randomization.
- Be sensitive to ACHEI.
- Be sensitive to two or more foods/drugs.
- Use of another investigational agent within one months of screening.
Sites / Locations
- Guangzhou Brain HospitalRecruiting
- Affiliated Hospital of Guilin Medical UniversityRecruiting
- Hebei mental health centerRecruiting
- Jiangsu Province HospitalRecruiting
- The first Affiliated Hospital of Jilin UniversityRecruiting
- First Affiliated Hospital of Kunming Medical UniversityRecruiting
- The First Affiliated Hospital of Medical School of Zhejiang UniversityRecruiting
- Beijing HuiLongGuan HospitalRecruiting
- Beijing Shijitan Hospital, EMURecruiting
- Shanghai Changzheng HospitalRecruiting
- Shanghai First People's HospitalRecruiting
- Shanghai Tenth People's hospitalRecruiting
- ShanghaiRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
low dose
Moderate dose
High dose
Placebo
Arm Description
1mg, tid
2mg,tid
4mg,tid
0 mg, tid
Outcomes
Primary Outcome Measures
Alzheimer's Disease Assessment Scale - Cognitive Subscale
Secondary Outcome Measures
Clinician's Interview Based Impression of Change, plus caregiver input
Activities of Daily Living:Activities of Daily Living Scale（ADL)
Mental behavior: neuropsychiatric questionnaire (NPI)
Full Information
NCT ID
NCT01569516
First Posted
March 30, 2012
Last Updated
April 6, 2012
Sponsor
Changchun Huayang High-tech Co., Ltd
Collaborators
Beijing Bionovo Medicine Development Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01569516
Brief Title
Study of Octohydroaminoacridine Succinate Tablets in Patients With Alzheimer's Disease
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Unknown status
Study Start Date
June 2011 (undefined)
Primary Completion Date
July 2012 (Anticipated)
Study Completion Date
October 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Changchun Huayang High-tech Co., Ltd
Collaborators
Beijing Bionovo Medicine Development Co., Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Alzheimer's Disease, Octohydroaminoacridine Succinate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
288 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
low dose
Arm Type
Experimental
Arm Description
1mg, tid
Arm Title
Moderate dose
Arm Type
Experimental
Arm Description
2mg,tid
Arm Title
High dose
Arm Type
Experimental
Arm Description
4mg,tid
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
0 mg, tid
Intervention Type
Drug
Intervention Name(s)
Octohydroaminoacridine Succinate Tablets
Intervention Description
1mg, tid
Intervention Type
Drug
Intervention Name(s)
Octohydroaminoacridine Succinate Tablets
Intervention Description
1st-2nd week, 1mg, tid 3rd -16th week, 2mg, tid
Intervention Type
Drug
Intervention Name(s)
Octohydroaminoacridine succinate Tablets
Intervention Description
1st-2nd week, 1mg, tid, 3rd -4th week, 2mg, tid, 5th-16th week, 4mg, tid
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
0mg, tid
Primary Outcome Measure Information:
Title
Alzheimer's Disease Assessment Scale - Cognitive Subscale
Time Frame
20weeks
Secondary Outcome Measure Information:
Title
Clinician's Interview Based Impression of Change, plus caregiver input
Time Frame
20weeks
Title
Activities of Daily Living:Activities of Daily Living Scale（ADL)
Time Frame
20weeks
Title
Mental behavior: neuropsychiatric questionnaire (NPI)
Time Frame
20weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of probable AD based on DSM-IV and the NINCDS-ADRDA criteria.
Male/female patient aged between 50 and 85.
mild to moderate probable AD ：Middle school or above: 11 ≤MMSE ≤ 25, elementary school: 8 ≤ MMSE ≤ 20, illiteracy: 5 ≤ MMSE ≤ 16.
CT or MRI scan excluding another structural brain disease in one year.
Neurologic examination no significant abnormalities.
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.
Stable chaperone, more than 2 hours a day together with the patient or accumulated fewer than 14 hours per week.
Informed consent of the patient (or legal representative) and of the caregiver agreeing to take part in the study.
Exclusion Criteria:
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.
Sudden onset of early dementia or with gait disorders, seizures and behavioral changes.
Clinical manifestations of focal neurological signs (hemiparesis, sensory loss, visual field defect) or early extrapyramidal tract signs.
History of cerebrovascular disease and stroke.
Serious lack of folic acid and VitB12, syphilis antibody positive or thyroid dysfunction.
Mechanical intestinal obstruction patient ,Resting pulse less than 60,Severe liver or renal disease.
Patients with mechanical intestinal obstruction.
History of bone marrow transplantation.Mental illness, such as severe depression.
Cognitive damage caused by alcohol or drug abuse. Disable to correctly evaluate the cognitive function.
Critical condition, disable to make the exact evaluation of the efficacy and safety of new drug.
Use of any agent for the treatment of dementia within 4 weeks of randomization.
Be sensitive to ACHEI.
Be sensitive to two or more foods/drugs.
Use of another investigational agent within one months of screening.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huafang Li, MD
Phone
86-21-64387250
Ext
3128
Email
lhlh5@yahoo.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shifu Xiao, MD
Organizational Affiliation
Shanghai Mental Health Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangzhou Brain Hospital
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hui Li
Phone
86-20-81898313
First Name & Middle Initial & Last Name & Degree
Muni Tang, MD
Facility Name
Affiliated Hospital of Guilin Medical University
City
Guilin
State/Province
Guangxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Chen
Phone
86-13737710329
Email
glfyli@163.com
First Name & Middle Initial & Last Name & Degree
Kaixiang Liu
Facility Name
Hebei mental health center
City
Baoding
State/Province
Hebei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qinpu Jiang
Email
JiangQinpu@yahoo.cn
First Name & Middle Initial & Last Name & Degree
Qinpu Jiang
Facility Name
Jiangsu Province Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tianping Li
Phone
86-25-68136221
Email
jsphkj@163.com
First Name & Middle Initial & Last Name & Degree
Weixian Chen
Facility Name
The first Affiliated Hospital of Jilin University
City
Changchun
State/Province
Jilin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fei Wang
Phone
13500815780
First Name & Middle Initial & Last Name & Degree
Li Sun, MD
Facility Name
First Affiliated Hospital of Kunming Medical University
City
Kunming
State/Province
Yunnan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jian Qin
Email
qinjian3337@sina.com
First Name & Middle Initial & Last Name & Degree
Yan Bai
Facility Name
The First Affiliated Hospital of Medical School of Zhejiang University
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benyan Luo
Email
luobenyan@zju.edu.cn
First Name & Middle Initial & Last Name & Degree
Min Tang
Email
tangmintj@hotmail.com
First Name & Middle Initial & Last Name & Degree
Benyan Luo
Facility Name
Beijing HuiLongGuan Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guanghui Zhang
Email
zhgh1998@126.com
First Name & Middle Initial & Last Name & Degree
Lan Shang
Facility Name
Beijing Shijitan Hospital, EMU
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shumei Wang
Email
13811830809@126.com
First Name & Middle Initial & Last Name & Degree
Jing Zhang
Facility Name
Shanghai Changzheng Hospital
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhongxin Zhao, MD
Email
zhaozx@medmail.com
First Name & Middle Initial & Last Name & Degree
Liuqing Huang, MD
Email
huangliuqing2008@hotmail.com
First Name & Middle Initial & Last Name & Degree
Zhongxin Zhao, MD
First Name & Middle Initial & Last Name & Degree
Liuqing Huang
Facility Name
Shanghai First People's Hospital
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaohua Li
Phone
86-21-63240090
Ext
6410
First Name & Middle Initial & Last Name & Degree
Xiaoping Wang
Facility Name
Shanghai Tenth People's hospital
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jie Yu
First Name & Middle Initial & Last Name & Degree
Xueyuan Liu
Facility Name
Shanghai
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huafang Li
Phone
86-21-64387250
Ext
3128
Email
Lhly5@yahoo.com.cn
First Name & Middle Initial & Last Name & Degree
Shifu Xiao, MD
First Name & Middle Initial & Last Name & Degree
Xia Li, MD
12. IPD Sharing Statement
Learn more about this trial
Study of Octohydroaminoacridine Succinate Tablets in Patients With Alzheimer's Disease
We'll reach out to this number within 24 hrs