Alzheimer’s Disease
Conditions
Interventions
low dose group in mild AD:MN-08 tablet
middle dose group in mild AD:MN-08 tablet
high dose group in mild AD :MN-08 tablet
placebo group in mild AD:placebo tablet
low dose group in moderate-severe AD:MN-08 tablet
middle dose group in moderate-severe AD:MN-08 tablet
high dose group in moderate-severe AD:MN-08 tablet
placebo group in moderate-severe AD:placebo tablet
Sponsors
Beijing Tiantan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
50 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Male or female aged =50 and =85 years old; 2. Subjects have the ability to complete the cognitive ability and other tests stipulated in study protocol with graduation from primary school or above; 3. Meet the criteria for the likely diagnosis of AD of Version V revised by the Diagnostic and Statistical Manual of Mental Disorders (DSM-V), the working group of the American Society of Neurology, Speech Disorders, and Stroke-Alzheimer's Disease and Related Disorders (NINCDSADRDA) or the National Institute on Aging and the Alzheimer's Disease Association (NIA-AA); 4. Memory loss has lasted for at least 12 months and is progressively worse; 5. MMSE scores of subjects with mild AD range from 21-26 (inclusive) during screening and baseline period; 6. MMSE scores of subjects with moderate-severe AD range from 21-26 (inclusive) during screening and baseline period; 7. The total score of the Hamilton Depression Scale is =10; 8. The score of the Haczynski ischemia Scale (HIS) is =4; 9. The greatest likelihood of AD is observed via MRI during screening. If subjects provide brain MRI films meeting the requirements of the study protocol within 6 months before screening, the result can be used as the basis for enrollment without repeated MRI examination, while an MRI of the forebrain will be conducted if the Investigator is unable to determine whether the condition of the subjects has changed; 10. No obvious focal disorders were observed in the neurological examination; 11. Subjects should have a stable and reliable caregiver, or contact with a caregiver frequently for at least 2 hours a day and 4 days a week, who will help them throughout the study. Caregivers must accompany subjects to visits and have sufficient interaction and communication with subjects to finish scales of ADCS-ADL, CIBIC-plus, NPI, and so on. 12. Male subjects, if accompanied by a female partner of reproductive age, will be required to take effective contraception from 30 days before the first dose to 30 days after the last dose; 13. Female subjects of childbearing age or menopausal less than 24 weeks must have a negative urine pregnancy test during the screening period, and take effective contraception from 30 days before the first dose to 30 days after the last dose; 14. Informed consent form is voluntarily signed by the subject or guardian/family member. the signature of the subject is allowed to be blank and followed by an explanation if the subject cannot sign for cognitive limitations or other reasons, and the guardian/family member shall sign the informed consent and the area of reasonable explanation.
Exclusion criteria
Exclusion criteria: 1.Dementia caused by other reasons, including vascular dementia, central nervous system infection, like HIV/AIDS, syphilis and so on, crew-jakob disease, Huntington's disease, Parkinson's disease, dementia with Lewy bodies, dementia with traumatic brain, other physical and chemical factors, such as drug poisoning, alcoholism, carbon monoxide poisoning and so on, important body disease, such as hepatic encephalopathy, pulmonary encephalopathy and so on, the endocrine system lesion, such as thyroid disease, parathyroid disease, deficiency of vitamin B12 and folic acid, or dementia caused by any other known reasons; 2. Uncorrectable disability of vision and hearing resulting in the assessment of scales affected or difficult to be completed; 3. Unable to tolerate MRI examination or have MRI contraindications, including but not limited to the presence of pacemakers incompatible with MRI, the presence of aneurysm clips, artificial heart valves, ear implants, eye, skin or internal metal implants unsuitable for MRI scanning, or presence of any other clinical history or findings that could lead to potential harm from MRI examination judged by the Investigator; 4. Attacked by central nervous system diseases with clinical significance diagnosed via imaging, including hydrocephalus, stroke, brain occupying lesions, brain infection, and so on; 5. Attacked by a past or existing systemic vascular disease with clinical significance that may affect cognitive function judged by the Investigator, including heart failure, atrial fibrillation, coronary heart disease, aortic dissection, hemangioma, and so on; 6. Attacked by autoimmune diseases, including multiple sclerosis, lupus erythematosus, antiphospholipid antibody syndrome, Bessette's disease, and so on; 7. Psychiatric patients suffering from amnesia, schizophrenia, schizoaffective disorder, bipolar disorder, major depressive episode, panic, or post-traumatic stress disorder according to the DSM-V; 8. Attempt suicide within the 6 months prior to screening, have a history of suicide within the 2 years prior to screening, have a C-SSRS score of 4 or 5 at baseline, or have the tendency to suicide judged by the Investigator; 9. A medical history of chronic heart failure (NYHA III-IV), acute heart failure, unstable angina, acute myocardial infarction, or another serious heart disease within 6 months prior to screening; 10. Severe renal insufficiency or liver insufficiency with creatinine clearance 3 times the upper limit of normal value, or other known serious liver diseases such as acute and chronic hepatitis, cirrhosis; 11. Glycosylated hemoglobin A1c (HbA1C) > 9.0% at screening while retesting is allowed if elevation is mild, or attacked by diabetes with poorly controlled insulin; 12. Poor control of hypertension with decubitus systolic blood pressure =160 mmHg or <90 mmHg, or diastolic Pressure =100 mmHg or <60 mmHg prior to randomization; 13. Attacked by chronic or severe gastrointestinal disease affecting drug absorption at screening; 14. Attacked by any other serious or unstable disease that the Investigator believes may progress, relapse, or worsen to place the subject at special risk resulting in a serious bias in the assessment of the subject's clinical or psychiatric and a bad influence on the subject's ability to complete the study assessment; 15. A history of alcohol an
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Alzheimer's Disease Assessment Scale - Cognitive subscale;Severe Impairment Battery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinician's Interview-Based Impression of Change Plus caregiver input;Alzheimer's Disease Cooperative Study Activities of Daily Living, 23 Items;Alzheimer's Disease Assessment Scale - Cognitive subscale;Neuropsychiatric Inventory Questionnaire;mini-mental state examination;cerebral blood flow;Alzheimer's Disease Cooperative Study Activities of Daily Living, 19 Items; | — |
Countries
China
Contacts
Public ContactJiong Shi
Outcome results
None listed