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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
288

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Alzheimer's Disease Assessment Scale - Cognitive Subscale
Time Frame: 20weeks
20weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Changchun Huayang High-tech Co., Ltd

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Beijing Bionovo Medicine Development Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2011

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2012

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 30, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 3, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 9, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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