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

Alzheimer's Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01569516
• Other study ID #: CCHY2010L00161-HPAD2
• Status: Recruiting
• Phase: Phase 2
• First received: March 30, 2012
• Last updated: April 6, 2012
• Start date: June 2011
• Est. completion date: October 2012

Study information

• Verified date: May 2011
• Source: Changchun Huayang High-tech Co., Ltd
• Contact: Huafang Li, MD
• Phone: 86-21-64387250
• Email: lhlh5[@]yahoo.com.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 288
• Est. completion date: October 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• Octohydroaminoacridine Succinate Tablets
1mg, tid
• Octohydroaminoacridine Succinate Tablets
1st-2nd week, 1mg, tid 3rd -16th week, 2mg, tid
• Octohydroaminoacridine succinate Tablets
1st-2nd week, 1mg, tid, 3rd -4th week, 2mg, tid, 5th-16th week, 4mg, tid
• Placebo
0mg, tid

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Changchun Huayang High-tech Co., Ltd	Beijing Bionovo Medicine Development Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alzheimer's Disease Assessment Scale - Cognitive Subscale		20weeks	No
Secondary	Clinician's Interview Based Impression of Change, plus caregiver input		20weeks	No
Secondary	Activities of Daily Living:Activities of Daily Living Scale(ADL)		20weeks	No
Secondary	Mental behavior: neuropsychiatric questionnaire (NPI)		20weeks	No