Clinical trial: Octohydroaminoacridine Succinate Tablet for Mild-to-Moderate Alzheimer's Disease (NCT03283059)

Eligibility 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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.
Subject must be at most 85 Years

Patient description (medical language): A 70-year-old man comes to the office accompanied by his wife.  The patient has experienced progressive memory loss over the last years.  He needs help with some of his routine activities, such as paying bills.  The patient's wife says, "He used to be such an independent person, but now he needs help with many things, even finding direction to home!"  Medical history includes hypertension, hyperlipidemia, and type 2 diabetes mellitus.  Family history includes Alzheimer disease in his father.  MRI reveals diffuse cortical and hippocampal atrophy. The diagnosis of AD is made using the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria.

Patient description (patient's own words): I am a 70-year-old man, and I paid a visit to the doctor with my wife the other day. I noticed that I tend to forget small things and that my memory has decreased over the past few years. I even ask my wife to help me out with my daily routine. I used to be the one paying the bills, but now she has to give me a hand. My wife mentioned to the doctor that I used to be independent and that I tend to forget where we live. I suffer from hypertension, high cholesterol, and type 2 diabetes. My poor dad was suffering from Alzheimer disease, so I hope I'm not going to end the same way! I did an MRI and they found out that some part of my brain was decreasing. I also did an Alzheimer test.

Does the patient match the trial criteria? Entailment