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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
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
  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:


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   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01569516

Locations
China, Guangdong
Guangzhou Brain Hospital
Guangzhou, Guangdong, China
China, Guangxi
Affiliated Hospital of Guilin Medical University
Guilin, Guangxi, China
China, Hebei
Hebei mental health center
Baoding, Hebei, China
China, Jiangsu
Jiangsu Province Hospital
Nanjing, Jiangsu, China
China, Jilin
The first Affiliated Hospital of Jilin University
Changchun, Jilin, China
China, Yunnan
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
China, Zhejiang
The First Affiliated Hospital of Medical School of Zhejiang University
Hangzhou, Zhejiang, China
China
Beijing HuiLongGuan Hospital
Beijing, China
Beijing Shijitan Hospital, EMU
Beijing, China
Shanghai Changzheng Hospital
Shanghai, China
Shanghai First People's Hospital
Shanghai, China
Shanghai Tenth People's hospital
Shanghai, China
Shanghai
Shanghai, China
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

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
Neurocognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on December 02, 2016