Clinical trial NCT01569516: Study of Octohydroaminoacridine Succinate Tablets in Patients With Alzheimer's Disease
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Alzheimer's Disease
Keywords: Alzheimer's Disease
Octohydroaminoacridine Succinate
Lead sponsor: Changchun Huayang High-tech Co., Ltd
Sponsor class: INDUSTRY
Collaborators: name: Beijing Bionovo Medicine Development Co., Ltd.
First posted: 2012-04-03
Enrollment: 288
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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.

Primary outcomes:
measure: Alzheimer's Disease Assessment Scale - Cognitive Subscale
timeFrame: 20weeks
Secondary outcomes:
measure: Clinician's Interview Based Impression of Change, plus caregiver input
timeFrame: 20weeks
measure: Activities of Daily Living:Activities of Daily Living Scale（ADL)
timeFrame: 20weeks
measure: Mental behavior: neuropsychiatric questionnaire (NPI)
timeFrame: 20weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou Brain Hospital
state: Guangdong
city: Guilin
country: China
facility: Affiliated Hospital of Guilin Medical University
state: Guangxi
city: Baoding
country: China
facility: Hebei mental health center
state: Hebei
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Changchun
country: China
facility: The first Affiliated Hospital of Jilin University
state: Jilin
city: Kunming
country: China
facility: First Affiliated Hospital of Kunming Medical University
state: Yunnan
city: Hangzhou
country: China
facility: The First Affiliated Hospital of Medical School of Zhejiang University
state: Zhejiang
city: Beijing
country: China
facility: Beijing HuiLongGuan Hospital
city: Beijing
country: China
facility: Beijing Shijitan Hospital, EMU
city: Shanghai
country: China
facility: Shanghai Changzheng Hospital
city: Shanghai
country: China
facility: Shanghai First People's Hospital
city: Shanghai
country: China
facility: Shanghai Tenth People's hospital
city: Shanghai
country: China
facility: Shanghai
Study officials:
affiliation: Shanghai Mental Health Center
name: Shifu Xiao, MD
role: PRINCIPAL_INVESTIGATOR
References: