Alzheimer's DiseasePhase 2NCT01569516
Study of Octohydroaminoacridine Succinate Tablets in Patients With Alzheimer's Disease
A Phase 2 study testing Octohydroaminoacridine Succinate Tablets in people with Alzheimer's Disease, run by Changchun Huayang High-tech Co., Ltd at 13 sites in China.
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. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Octohydroaminoacridine Succinate Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 288 participants
- Where
- 13 sitesChina
- Study dates
- Jun 2011to Oct 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
China13 sites, 13 recruiting
- Recruiting
Hebei mental health center
Baoding, Hebei
Qinpu Jiang, JiangQinpu@yahoo.cn
Qinpu Jiang
- Recruiting
Beijing HuiLongGuan Hospital
Beijing
Guanghui Zhang, zhgh1998@126.com
Lan Shang
- Recruiting
Beijing Shijitan Hospital, EMU
Beijing
Shumei Wang, 13811830809@126.com
Jing Zhang
- Recruiting
The first Affiliated Hospital of Jilin University
Changchun, Jilin
Fei Wang, 13500815780
Li Sun, MD
- Recruiting
Guangzhou Brain Hospital
Guangzhou, Guangdong
Hui Li, 86-20-81898313
Muni Tang, MD
- Recruiting
Affiliated Hospital of Guilin Medical University
Guilin, Guangxi
Wei Chen, 86-13737710329, glfyli@163.com
Kaixiang Liu
- Recruiting
The First Affiliated Hospital of Medical School of Zhejiang University
Hangzhou, Zhejiang
Benyan Luo, luobenyan@zju.edu.cn
Min Tang, tangmintj@hotmail.com
- Recruiting
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan
Jian Qin, qinjian3337@sina.com
Yan Bai
- Recruiting
Jiangsu Province Hospital
Nanjing, Jiangsu
Tianping Li, 86-25-68136221, jsphkj@163.com
Weixian Chen
- Recruiting
Shanghai Changzheng Hospital
Shanghai
Zhongxin Zhao, MD, zhaozx@medmail.com
Liuqing Huang, MD, huangliuqing2008@hotmail.com
- Recruiting
Shanghai First People's Hospital
Shanghai
Xiaohua Li, 86-21-63240090 ext. 6410
Xiaoping Wang
- Recruiting
Shanghai Tenth People's hospital
Shanghai
Jie Yu
Xueyuan Liu
- Recruiting
Shanghai
Shanghai
Huafang Li, 86-21-64387250 ext. 3128, Lhly5@yahoo.com.cn
Shifu Xiao, MD
About this study
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
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.
Read the 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.
- Conditions
- Alzheimer's Disease
- Being tested
- Octohydroaminoacridine Succinate Tablets, Placebo
- Keywords
- Alzheimer's Disease, Octohydroaminoacridine Succinate
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Octohydroaminoacridine Succinate TabletsDrug
1mg, tid
Octohydroaminoacridine Succinate TabletsDrug
1st-2nd week, 1mg, tid 3rd -16th week, 2mg, tid
Octohydroaminoacridine succinate TabletsDrug
1st-2nd week, 1mg, tid, 3rd -4th week, 2mg, tid, 5th-16th week, 4mg, tid
PlaceboDrug
0mg, tid
| Study group | Role | What they receive |
|---|---|---|
| low dose | Experimental | 1mg, tid Receives: Drug: Octohydroaminoacridine Succinate Tablets |
| Moderate dose | Experimental | 2mg,tid Receives: Drug: Octohydroaminoacridine Succinate Tablets |
| High dose | Experimental | 4mg,tid Receives: Drug: Octohydroaminoacridine succinate Tablets |
| Placebo | Placebo comparator | 0 mg, tid Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alzheimer's Disease Assessment Scale - Cognitive Subscale
Measured: 20weeks
Secondary outcomes (3)
Clinician's Interview Based Impression of Change, plus caregiver input
Measured: 20weeks
Activities of Daily Living:Activities of Daily Living Scale（ADL)
Measured: 20weeks
Mental behavior: neuropsychiatric questionnaire (NPI)
Measured: 20weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2012 (estimated)
- Study startJun 2011
- Primary completionJul 2012 (estimated)
- Study completionOct 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 288 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changchun Huayang High-tech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Beijing Bionovo Medicine Development Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Shifu Xiao, MD, Principal investigator, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01569516
- Sponsor's protocol ID
- CCHY2010L00161-HPAD2
- Status last verified
- May 2011
- First submitted
- 30 Mar 2012
- Last updated
- 9 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01569516
- Acronym / sponsor ID
- CCHY2010L00161-HPAD2
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's Disease, Octohydroaminoacridine Succinate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 288 participants (estimated)
- Lead sponsor
- Changchun Huayang High-tech Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Beijing Bionovo Medicine Development Co., Ltd.
- Study start
- Jun 2011
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Oct 2012 (estimated)
- First posted
- 3 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| low dose | Experimental | Drug: Octohydroaminoacridine Succinate Tablets1mg, tid |
| Moderate dose | Experimental | Drug: Octohydroaminoacridine Succinate Tablets2mg,tid |
| High dose | Experimental | Drug: Octohydroaminoacridine succinate Tablets4mg,tid |
| Placebo | Placebo comparator | Drug: Placebo0 mg, tid |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Octohydroaminoacridine Succinate Tablets1mg, tid | Drug | low dose |
| Octohydroaminoacridine Succinate Tablets1st-2nd week, 1mg, tid 3rd -16th week, 2mg, tid | Drug | Moderate dose |
| Octohydroaminoacridine succinate Tablets1st-2nd week, 1mg, tid, 3rd -4th week, 2mg, tid, 5th-16th week, 4mg, tid | Drug | High dose |
| Placebo0mg, tid | Drug | Placebo |
Primary outcome
Alzheimer's Disease Assessment Scale - Cognitive Subscale
Time frame: 20weeks
3 secondary outcomes
Clinician's Interview Based Impression of Change, plus caregiver input
Time frame: 20weeks
Activities of Daily Living:Activities of Daily Living Scale（ADL)
Time frame: 20weeks
Mental behavior: neuropsychiatric questionnaire (NPI)
Time frame: 20weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shifu Xiao, MD principal investigator
Shanghai Mental Health Center
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Octohydroaminoacridine Succinate Tablets in people with Alzheimer's Disease, run by Changchun Huayang High-tech Co., Ltd at 13 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huafang Li, MD (86-21-64387250 ext. 3128, lhlh5@yahoo.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alzheimer's Disease Assessment Scale - Cognitive Subscale (time frame: 20weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2012.