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
Sponsor:
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

March 30, 2012
April 6, 2012
June 2011
July 2012   (final data collection date for primary outcome measure)
Alzheimer's Disease Assessment Scale - Cognitive Subscale [ Time Frame: 20weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01569516 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Clinician's Interview Based Impression of Change, plus caregiver input [ Time Frame: 20weeks ] [ Designated as safety issue: No ]
  • Neuropsychiatric Inventory Time Frame: week 24 Measure: Activities of Daily Living [ Time Frame: 20weeks ] [ Designated as safety issue: No ]
  • Neuropsychiatric Inventory [ Time Frame: 20weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study of Octohydroaminoacridine Succinate Tablets in Patients With Alzheimer's Disease
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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Alzheimer's Disease
  • Drug: Octohydroaminoacridine Succinate Tablets
    1mg, tid
  • Drug: Octohydroaminoacridine Succinate Tablets
    1st-2nd week, 1mg, tid 3rd -16th week, 2mg, tid
  • Drug: Octohydroaminoacridine succinate Tablets
    1st-2nd week, 1mg, tid, 3rd -4th week, 2mg, tid, 5th-16th week, 4mg, tid
  • Drug: Placebo
    0mg, tid
  • Experimental: low dose
    1mg, tid
    Intervention: Drug: Octohydroaminoacridine Succinate Tablets
  • Experimental: Moderate dose
    2mg,tid
    Intervention: Drug: Octohydroaminoacridine Succinate Tablets
  • Experimental: High dose
    4mg,tid
    Intervention: Drug: Octohydroaminoacridine succinate Tablets
  • Placebo Comparator: Placebo
    0 mg, tid
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
288
October 2012
July 2012   (final data collection date for primary outcome measure)

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.
Both
50 Years to 85 Years
No
Contact: Huafang Li, MD 86-21-64387250 ext 3128 lhlh5@yahoo.com.cn
China
 
NCT01569516
CCHY2010L00161-HPAD2
Yes
Changchun Huayang High-tech Co., Ltd
Changchun Huayang High-tech Co., Ltd
Beijing Bionovo Medicine Development Co., Ltd.
Principal Investigator: Shifu Xiao, MD Shanghai Mental Health Center
Changchun Huayang High-tech Co., Ltd
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP