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Trial record 6 of 47 for:    Alzheimer Disease | China

Octohydroaminoacridine Succinate Tablet for Mild-to-Moderate Alzheimer's Disease

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ClinicalTrials.gov Identifier: NCT03283059
Recruitment Status : Recruiting
First Posted : September 14, 2017
Last Update Posted : October 10, 2017
Sponsor:
Collaborators:
Changchun Huayang High-tech Co., Ltd
Jiangsu Sheneryang High-tech Co., Ltd
Information provided by (Responsible Party):
Shanghai Mental Health Center

Brief Summary:
Inhibition of acetylcholinesterase has been a effective treatment for Alzheimer's disease. Octohydroaminoacridine, a new acetylcholinesterase inhibitor, is a potential treatment for Alzheimer's disease. The investigators conducted a 26 weeks, randomized, double-blind, double-dummy, placebo- and positive- parallel controlled and extended single arm to 54 weeks multicentre phase III clinical trial to investigate the effects of octohydroaminoacridine in patients with mild-to-moderate Alzheimer's disease. Patients were randomized to receive placebo thrice daily, or octohydroaminoacridine 4 mg/TID or ARICEPT 5mg/QD.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Drug: Octohydroaminoacridine Succinate Drug: Aricept Drug: Placebos Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Phase III Trial of Octohydroaminoacridine Succinate Tablet for Mild-to-Moderate Alzheimer's Disease: a 26 Weeks, Randomized, Double-blind, Double-dummy, Placebo- and Positive- Parallel Controlled and Extended Single Arm to 54 Weeks Multicentre Study
Actual Study Start Date : August 16, 2017
Estimated Primary Completion Date : September 16, 2019
Estimated Study Completion Date : February 16, 2020


Arm Intervention/treatment
Experimental: Octohydroaminoacridine Succinate Tablet
Octohydroaminoacridine Succinate Tablet 4mg P.O. tid
Drug: Octohydroaminoacridine Succinate
Octohydroaminoacridine Succinate Tablet:4mg P.O. tid

Active Comparator: Aricept
Aricept 5mg/day P.O.
Drug: Aricept
Aricept 5mg/day, P.O.

Placebo Comparator: Placebo
Placebo P.O. tid
Drug: Placebos
Placebo Tablet: P.O. tid




Primary Outcome Measures :
  1. Alzheimer's Disease Assessment Scale-Cognitive section (ADAS-Cog) [ Time Frame: 26 weeks double-blind study and 28 weeks extention study ]
    The change of ADAS-Cog from baseline to endpoint among three arms.


Secondary Outcome Measures :
  1. Clinician's Interview Based Impression of Change - plus (CIBIC+) [ Time Frame: 26 weeks double-blind study and 28 weeks extention study ]
    The change of CIBIC+ from baseline to endpoint among three arms.

  2. Activities of Daily Living (ADL) [ Time Frame: 26 weeks double-blind study and 28 weeks extention study ]
    The change of ADL from baseline to endpoint among three arms.

  3. Neuropsychiatric Inventory (NPI) [ Time Frame: 26 weeks double-blind study and 28 weeks extention study ]
    The change of NPI from baseline to endpoint among three arms.



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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 50-85 years (including 50 and 85 years old), male or female;
  2. Diagnose probable AD in accordance with the National Institute Aging and Alzheimer's Association (NIA-AA) (2011);
  3. Mild-to-moderate AD patients, MMSE 11-26 (including 11 and 26, primary school education subjects from 11 to 22);
  4. Hachinski Incheinic Score (HIS) less than 4 points;
  5. Hamilton depression scale /17 Version (HAMD) score less than 10 points;
  6. Memory decline at least 12 months, and the decline is progressive;
  7. Brain MRI examination was done within 6 months before screening;
  8. Neurological examination had no obvious signs (except due to AD disease or peripheral injury);
  9. Females were postmenopausal (menopause beyond 24 weeks), or accepted the surgical sterilization, or women of childbearing age agreed to take effective contraceptive measures during the study. Women of childbearing age or menopausal time shorter than 24 weeks must do the urine pregnancy test and results to be negative during the screening period;
  10. Subjects should have stable and reliable caregivers, or have frequent contact with caregivers (at least 4 days per week, at least 2 hours per day), caregivers will help patients to participate in the study. Caregivers must accompany the subjects in the study visit to provide valuable information for the NPI, ADCS-ADL and CIBIC-plus scales assessments;
  11. Subjects have at least primary school education level, and have the ability to complete the determination of cognitive ability assessments and other tests;
  12. The participants and legal guardian must sign informed consent.

Exclusion Criteria:

  1. Brain MRI examination showed significant focal lesions, moderate-to-severe white matter lesions, and key parts lacunar infarction such as the thalamus, hippocampus, entorhinal cortex, cortical and subcortical gray matter nuclei;
  2. Other type of dementia except AD;
  3. Suffered from nervous system diseases (including stroke, optic myelopathy, Parkinson's disease, epilepsy, etc);
  4. Psychotic patients, according to the DSM-5 criteria, include schizophrenia or other psychiatry disorders, bipolar disorder, major depression disorder, or delirium;
  5. Abnormal laboratory test results: HBsAg and HBeAg and/or HbcAb positive and active stage of hepatitis B, liver function (ALT, AST) more than 1.2 times of the upper limit of the normal range, Cr exceeds the upper limit of normal, white blood cell count less than 4 x 109/L or platelet less than 100 x 109/L, hemoglobin less than 100g/L, blood glucose concentration of diabetic subjects (random) is more than 13.9mmol/L;
  6. Systolic pressure was more than 160mmHg or less than 90mmHg, diastolic blood pressure was more than 100mmHg or less than 60mmHg;
  7. With unstable or serious heart, lung, liver, kidney and hematopoietic system diseases (including unstable angina, myocardial infarction, uncontrolled asthma, gastric cancer, et al), or resting heart rate after 10 minutes of rest was less than 60 BPM, or QTc (QTc B (Bazett's correction value) or QTc F (Fridericia's correction value)) was equal or greater than 450msec, or with bundle branch block, the QTc B or QTc F was equal or greater than 480msec, or the researchers estimate there were abnormal EKG results which cannot be randomized to the study;
  8. There was uncorrected of visual and auditory disturbances, and neuropsychological tests and scale assessments cannot be completed by the subject;
  9. Subject was currently using Alzheimer's disease drugs and cannot be terminate the treatment;
  10. Subjects that cannot take the test drug according to the prescription should be excluded;
  11. Alcohol abuse or drug abuse;
  12. Pregnant or lactating women;
  13. Participated in other clinical pharmacological tests within 30 days before screening visit;
  14. The researchers believe that the subject was impossible to complete the study;
  15. Participants were employees of the study and immediate family members, employees of CRO company or sponsor and their immediate family members.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03283059


Contacts
Contact: Shifu Xiao, M.D., Ph.D. +86 21 64387250 ext 73441 xiaoshifu@msn.com
Contact: Tao Wang, M.D., Ph.D. +86 18017311279 wtshhwy@163.com

Locations
China, Shanghai
Shanghai Mental Health Center Recruiting
Shanghai, Shanghai, China, 200030
Contact: Shifu Xiao, M.D., Ph.D.    +86 21 64387250 ext 73441    xiaoshifu@msn.com   
Contact: Tao Wang, M.D., Ph.D.    +86 18017311279    wtshhwy@163.com   
Sponsors and Collaborators
Shanghai Mental Health Center
Changchun Huayang High-tech Co., Ltd
Jiangsu Sheneryang High-tech Co., Ltd
Investigators
Principal Investigator: Shifu Xiao, M.D., Ph.D. Shanghai Mental Health Center

Responsible Party: Shanghai Mental Health Center
ClinicalTrials.gov Identifier: NCT03283059     History of Changes
Other Study ID Numbers: OHAAS-III
First Posted: September 14, 2017    Key Record Dates
Last Update Posted: October 10, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Other researchers should apply to the sponsor.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Dementia
Tauopathies
Donepezil
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents