Study of Octohydroaminoacridine Succinate Tablets in Patients With Alzheimer's Disease

April 6, 2012 updated by: Changchun Huayang High-tech Co., Ltd

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

288

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Beijing HuiLongGuan Hospital
        • Contact:
        • Principal Investigator:
          • Lan Shang
      • Beijing, China
      • Shanghai, China
        • Recruiting
        • Shanghai Changzheng Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Zhongxin Zhao, MD
        • Sub-Investigator:
          • Liuqing Huang
      • Shanghai, China
        • Recruiting
        • Shanghai Tenth People's Hospital
        • Contact:
          • Jie Yu
        • Principal Investigator:
          • Xueyuan Liu
      • Shanghai, China
        • Recruiting
        • Shanghai First People's Hospital
        • Contact:
          • Xiaohua Li
          • Phone Number: 6410 86-21-63240090
        • Principal Investigator:
          • Xiaoping Wang
      • Shanghai, China
        • Recruiting
        • Shanghai
        • Contact:
        • Principal Investigator:
          • Shifu Xiao, MD
        • Sub-Investigator:
          • Xia Li, MD
    • Guangdong
      • Guangzhou, Guangdong, China
        • Recruiting
        • Guangzhou Brain Hospital
        • Contact:
          • Hui Li
          • Phone Number: 86-20-81898313
        • Principal Investigator:
          • Muni Tang, MD
    • Guangxi
      • Guilin, Guangxi, China
        • Recruiting
        • Affiliated Hospital of Guilin Medical University
        • Contact:
        • Principal Investigator:
          • Kaixiang Liu
    • Hebei
      • Baoding, Hebei, China
        • Recruiting
        • Hebei Mental Health Center
        • Contact:
        • Principal Investigator:
          • Qinpu Jiang
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Recruiting
        • Jiangsu Province Hospital
        • Contact:
        • Principal Investigator:
          • Weixian Chen
    • Jilin
      • Changchun, Jilin, China
        • Recruiting
        • The First Affiliated Hospital of Jilin University
        • Contact:
          • Fei Wang
          • Phone Number: 13500815780
        • Principal Investigator:
          • Li Sun, MD
    • Yunnan
      • Kunming, Yunnan, China
        • Recruiting
        • First Affiliated Hospital of Kunming Medical University
        • Contact:
        • Principal Investigator:
          • Yan Bai
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • The First Affiliated Hospital of Medical School of Zhejiang University
        • Contact:
        • Principal Investigator:
          • Benyan Luo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: low dose
1mg, tid
Drug: Octohydroaminoacridine Succinate Tablets
1mg, tid
Drug: Octohydroaminoacridine Succinate Tablets
1st-2nd week, 1mg, tid 3rd -16th week, 2mg, tid
Experimental: Moderate dose
2mg,tid
Drug: Octohydroaminoacridine Succinate Tablets
1mg, 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Alzheimer's Disease Assessment Scale - Cognitive Subscale
Time Frame: 20weeks
20weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinician's Interview Based Impression of Change, plus caregiver input
Time Frame: 20weeks
20weeks
Activities of Daily Living:Activities of Daily Living Scale（ADL)
Time Frame: 20weeks
20weeks
Mental behavior: neuropsychiatric questionnaire (NPI)
Time Frame: 20weeks
20weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changchun Huayang High-tech Co., Ltd

Collaborators

Beijing Bionovo Medicine Development Co., Ltd.

Investigators

  • Principal Investigator: Shifu Xiao, MD, Shanghai Mental Health Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Anticipated)

July 1, 2012

Study Completion (Anticipated)

October 1, 2012

Study Registration Dates

First Submitted

March 30, 2012

First Submitted That Met QC Criteria

March 30, 2012

First Posted (Estimate)

April 3, 2012

Study Record Updates

Last Update Posted (Estimate)

April 9, 2012

Last Update Submitted That Met QC Criteria

April 6, 2012

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCHY2010L00161-HPAD2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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