Study of Octohydroaminoacridine Succinate Tablets in Patients With Alzheimer's Disease
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Changchun Huayang High-tech Co., Ltd.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Changchun Huayang High-tech Co., Ltd
Collaborator:
Beijing Bionovo Medicine Development Co., Ltd.
Information provided by (Responsible Party):
Changchun Huayang High-tech Co., Ltd
ClinicalTrials.gov Identifier:
NCT01569516
First received: March 30, 2012
Last updated: April 6, 2012
Last verified: May 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Alzheimer's Disease |
Drug: Octohydroaminoacridine Succinate Tablets Drug: Octohydroaminoacridine succinate Tablets Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
Alzheimer disease
MedlinePlus related topics:
Alzheimer's Disease
Drug Information available for:
Succinic acid
U.S. FDA Resources
Further study details as provided by Changchun Huayang High-tech Co., Ltd:
Primary Outcome Measures:
- Alzheimer's Disease Assessment Scale - Cognitive Subscale [ Time Frame: 20weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Clinician's Interview Based Impression of Change, plus caregiver input [ Time Frame: 20weeks ] [ Designated as safety issue: No ]
- Activities of Daily Living:Activities of Daily Living Scale(ADL) [ Time Frame: 20weeks ] [ Designated as safety issue: No ]
- Mental behavior: neuropsychiatric questionnaire (NPI) [ Time Frame: 20weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 288 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | October 2012 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: low dose
1mg, tid
|
Drug: Octohydroaminoacridine Succinate Tablets
1mg, tid
|
|
Experimental: Moderate dose
2mg,tid
|
Drug: Octohydroaminoacridine Succinate Tablets
1st-2nd week, 1mg, tid 3rd -16th week, 2mg, tid
|
|
Experimental: High dose
4mg,tid
|
Drug: Octohydroaminoacridine succinate Tablets
1st-2nd week, 1mg, tid, 3rd -4th week, 2mg, tid, 5th-16th week, 4mg, tid
|
|
Placebo Comparator: Placebo
0 mg, tid
|
Drug: Placebo
0mg, tid
|
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.
Eligibility| Ages Eligible for Study: | 50 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01569516
Contacts
| Contact: Huafang Li, MD | 86-21-64387250 ext 3128 | lhlh5@yahoo.com.cn |
Locations
| China, Guangdong | |
| Guangzhou Brain Hospital | Recruiting |
| Guangzhou, Guangdong, China | |
| Contact: Hui Li 86-20-81898313 | |
| Principal Investigator: Muni Tang, MD | |
| China, Guangxi | |
| Affiliated Hospital of Guilin Medical University | Recruiting |
| Guilin, Guangxi, China | |
| Contact: Wei Chen 86-13737710329 glfyli@163.com | |
| Principal Investigator: Kaixiang Liu | |
| China, Hebei | |
| Hebei mental health center | Recruiting |
| Baoding, Hebei, China | |
| Contact: Qinpu Jiang JiangQinpu@yahoo.cn | |
| Principal Investigator: Qinpu Jiang | |
| China, Jiangsu | |
| Jiangsu Province Hospital | Recruiting |
| Nanjing, Jiangsu, China | |
| Contact: Tianping Li 86-25-68136221 jsphkj@163.com | |
| Principal Investigator: Weixian Chen | |
| China, Jilin | |
| The first Affiliated Hospital of Jilin University | Recruiting |
| Changchun, Jilin, China | |
| Contact: Fei Wang 13500815780 | |
| Principal Investigator: Li Sun, MD | |
| China, Yunnan | |
| First Affiliated Hospital of Kunming Medical University | Recruiting |
| Kunming, Yunnan, China | |
| Contact: Jian Qin qinjian3337@sina.com | |
| Principal Investigator: Yan Bai | |
| China, Zhejiang | |
| The First Affiliated Hospital of Medical School of Zhejiang University | Recruiting |
| Hangzhou, Zhejiang, China | |
| Contact: Benyan Luo luobenyan@zju.edu.cn | |
| Contact: Min Tang tangmintj@hotmail.com | |
| Principal Investigator: Benyan Luo | |
| China | |
| Beijing HuiLongGuan Hospital | Recruiting |
| Beijing, China | |
| Contact: Guanghui Zhang zhgh1998@126.com | |
| Principal Investigator: Lan Shang | |
| Beijing Shijitan Hospital, EMU | Recruiting |
| Beijing, China | |
| Contact: Shumei Wang 13811830809@126.com | |
| Principal Investigator: Jing Zhang | |
| Shanghai Tenth People's hospital | Recruiting |
| Shanghai, China | |
| Contact: Jie Yu | |
| Principal Investigator: Xueyuan Liu | |
| Shanghai Changzheng Hospital | Recruiting |
| Shanghai, China | |
| Contact: Zhongxin Zhao, MD zhaozx@medmail.com | |
| Contact: Liuqing Huang, MD huangliuqing2008@hotmail.com | |
| Principal Investigator: Zhongxin Zhao, MD | |
| Sub-Investigator: Liuqing Huang | |
| Shanghai | Recruiting |
| Shanghai, China | |
| Contact: Huafang Li 86-21-64387250 ext 3128 Lhly5@yahoo.com.cn | |
| Principal Investigator: Shifu Xiao, MD | |
| Sub-Investigator: Xia Li, MD | |
| Shanghai First People's Hospital | Recruiting |
| Shanghai, China | |
| Contact: Xiaohua Li 86-21-63240090 ext 6410 | |
| Principal Investigator: Xiaoping Wang | |
Sponsors and Collaborators
Changchun Huayang High-tech Co., Ltd
Beijing Bionovo Medicine Development Co., Ltd.
Investigators
| Principal Investigator: | Shifu Xiao, MD | Shanghai Mental Health Center |
More Information
No publications provided
| Responsible Party: | Changchun Huayang High-tech Co., Ltd |
| ClinicalTrials.gov Identifier: | NCT01569516 History of Changes |
| Other Study ID Numbers: | CCHY2010L00161-HPAD2 |
| Study First Received: | March 30, 2012 |
| Last Updated: | April 6, 2012 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Changchun Huayang High-tech Co., Ltd:
|
Alzheimer's Disease Octohydroaminoacridine Succinate |
Additional relevant MeSH terms:
|
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 22, 2013