Octohydroaminoacridine Succinate Tablet for Mild-to-Moderate Alzheimer's Disease
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|ClinicalTrials.gov Identifier: NCT03283059|
Recruitment Status : Unknown
Verified October 2019 by Shanghai Mental Health Center.
Recruitment status was: Recruiting
First Posted : September 14, 2017
Last Update Posted : October 22, 2019
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|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|
|Intervention Model:||Parallel Assignment|
|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, 2020|
|Estimated Study Completion Date :||February 16, 2021|
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.
Aricept 5mg/day, P.O.
Placebo Comparator: Placebo
Placebo P.O. tid
Placebo Tablet: P.O. tid
- 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.
- 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.
- 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.
- 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|
- Age 50-85 years (including 50 and 85 years old), male or female;
- Diagnose probable AD in accordance with the National Institute Aging and Alzheimer's Association (NIA-AA) (2011);
- Mild-to-moderate AD patients, MMSE 11-26 (including 11 and 26, primary school education subjects from 11 to 22);
- Hachinski Incheinic Score (HIS) less than 4 points;
- Hamilton depression scale /17 Version (HAMD) score less than 10 points;
- Memory decline at least 12 months, and the decline is progressive;
- Brain MRI examination was done within 6 months before screening;
- Neurological examination had no obvious signs (except due to AD disease or peripheral injury);
- 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;
- 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;
- Subjects have at least primary school education level, and have the ability to complete the determination of cognitive ability assessments and other tests;
- The participants and legal guardian must sign informed consent.
- 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;
- Other type of dementia except AD;
- Suffered from nervous system diseases (including stroke, optic myelopathy, Parkinson's disease, epilepsy, etc);
- Psychotic patients, according to the DSM-5 criteria, include schizophrenia or other psychiatry disorders, bipolar disorder, major depression disorder, or delirium;
- 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;
- Systolic pressure was more than 160mmHg or less than 90mmHg, diastolic blood pressure was more than 100mmHg or less than 60mmHg;
- 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;
- There was uncorrected of visual and auditory disturbances, and neuropsychological tests and scale assessments cannot be completed by the subject;
- Subject was currently using Alzheimer's disease drugs and cannot be terminate the treatment;
- Subjects that cannot take the test drug according to the prescription should be excluded;
- Alcohol abuse or drug abuse;
- Pregnant or lactating women;
- Participated in other clinical pharmacological tests within 30 days before screening visit;
- The researchers believe that the subject was impossible to complete the study;
- Participants were employees of the study and immediate family members, employees of CRO company or sponsor and their immediate family members.
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
|Contact: Shifu Xiao, M.D., Ph.D.||+86 21 64387250 ext email@example.com|
|Contact: Tao Wang, M.D., Ph.D.||+86 firstname.lastname@example.org|
|Shanghai Mental Health Center||Recruiting|
|Shanghai, Shanghai, China, 200030|
|Contact: Shifu Xiao, M.D., Ph.D. +86 21 64387250 ext 73441 email@example.com|
|Contact: Tao Wang, M.D., Ph.D. +86 18017311279 firstname.lastname@example.org|
|Principal Investigator:||Shifu Xiao, M.D., Ph.D.||Shanghai Mental Health Center|
|Responsible Party:||Shanghai Mental Health Center|
|Other Study ID Numbers:||
|First Posted:||September 14, 2017 Key Record Dates|
|Last Update Posted:||October 22, 2019|
|Last Verified:||October 2019|
|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|
Central Nervous System Diseases
Nervous System Diseases
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs