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
1 other identifier
interventional
288
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2011
Shorter than P25 for phase_2
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 30, 2012
CompletedFirst Posted
Study publicly available on registry
April 3, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedApril 9, 2012
May 1, 2011
1.1 years
March 30, 2012
April 6, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Alzheimer's Disease Assessment Scale - Cognitive Subscale
20weeks
Secondary Outcomes (3)
Clinician's Interview Based Impression of Change, plus caregiver input
20weeks
Activities of Daily Living:Activities of Daily Living Scale（ADL)
20weeks
Mental behavior: neuropsychiatric questionnaire (NPI)
20weeks
Study Arms (4)
low dose
EXPERIMENTAL1mg, tid
Moderate dose
EXPERIMENTAL2mg,tid
High dose
EXPERIMENTAL4mg,tid
Placebo
PLACEBO COMPARATOR0 mg, tid
Interventions
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of probable AD based on DSM-IV and the NINCDS-ADRDA criteria.
- Male/female patient aged between 50 and 85.
- mild to moderate probable AD ：Middle school or above: 11 ≤MMSE ≤ 25, elementary school: 8 ≤ MMSE ≤ 20, illiteracy: 5 ≤ MMSE ≤ 16.
- CT or MRI scan excluding another structural brain disease in one year.
- Neurologic examination no significant abnormalities.
- 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.
- Stable chaperone, more than 2 hours a day together with the patient or accumulated fewer than 14 hours per week.
- Informed consent of the patient (or legal representative) and of the caregiver agreeing to take part in the study.
You may not qualify if:
- 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.
- Sudden onset of early dementia or with gait disorders, seizures and behavioral changes.
- Clinical manifestations of focal neurological signs (hemiparesis, sensory loss, visual field defect) or early extrapyramidal tract signs.
- History of cerebrovascular disease and stroke.
- Serious lack of folic acid and VitB12, syphilis antibody positive or thyroid dysfunction.
- Mechanical intestinal obstruction patient ,Resting pulse less than 60,Severe liver or renal disease.
- Patients with mechanical intestinal obstruction.
- History of bone marrow transplantation.Mental illness, such as severe depression.
- Cognitive damage caused by alcohol or drug abuse. Disable to correctly evaluate the cognitive function.
- Critical condition, disable to make the exact evaluation of the efficacy and safety of new drug.
- Use of any agent for the treatment of dementia within 4 weeks of randomization.
- Be sensitive to ACHEI.
- Be sensitive to two or more foods/drugs.
- Use of another investigational agent within one months of screening.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Guangzhou Brain Hospital
Guangzhou, Guangdong, China
Affiliated Hospital of Guilin Medical University
Guilin, Guangxi, China
Hebei mental health center
Baoding, Hebei, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
The first Affiliated Hospital of Jilin University
Changchun, Jilin, China
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
The First Affiliated Hospital of Medical School of Zhejiang University
Hangzhou, Zhejiang, 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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shifu Xiao, MD
Shanghai Mental Health Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 30, 2012
First Posted
April 3, 2012
Study Start
June 1, 2011
Primary Completion
July 1, 2012
Study Completion
October 1, 2012
Last Updated
April 9, 2012
Record last verified: 2011-05