Alzheimer's disease
Conditions
Interventions
High-dose group:600 mg benfotiamine
low-dose group:300 mg benfotiamine
placebo:placebo
Sponsors
Huashan hospital of fudan university
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Aged 50-85 years (inclusive), no gender limitation; 2) Subjects have received education in primary school and above and are able to complete protocol specified cognitive ability test and other tests; 3) Probable AD based on the diagnosis criteria of NIA-AA guideline (the U.S. National Institute on Aging and Alzheimer's Association guideline, McKhann et al, 2011 4) Impaired memory for at least 12 months, with a tendency of progressive aggravation; 5) Patients with mild to moderate disease, i.e. 11 =total MMSE score =24 (for subjects with primary school education, 11 =total MMSE score =22);0.5 =CDR score =2; 6) A stable dose of donepezil for 24 weeks prior to enrollment; 7) Total Hachinski Ischemia Scale (HIS) score =4 ; 8) Total Hamilton Depression Scale/17-item (HAMD) score =10; 9) In screening, cranial MRI plain scan and oblique coronal hippocampus scan must be performed, MRI shows highest possibility of Alzheimer's disease (medial temporal lobe atrophy visual rating scale MTA grade =2);If the patient can provide in the first 3 months before screening program meets the requirements of the head MRI film, it can be used as the basis for inclusion. It does not have to repeat the shot; if the researcher can not determine whether the subject's condition changes, cranial MRI plain scan can be done again before the subject recruit to the group 10) Neurological examination shows no significant sign; 11) Subjects should have stable, reliable caregivers, or at least have frequent contact with caregivers (at least 3 days every week, at least 2 h every day), and caregivers will help patients in participation in this study. Caregivers must accompany subjects to participate in study visits and have sufficient interaction and communication with subjects, so as to provide valuable information on NPI, ADCS-ADL, CIBIC-plus scales; 12) Before implementation of any protocol related procedure or examination, both the subjects and legal guardians must sign the informed consent form.If subjects can not sign due to limited cognition, legal guardians should sign on behalf of subjects and meanwhile, legal guardians should also sign the informed consent form.
Exclusion criteria
Exclusion criteria: screening period, MRI examination showed significant focal lesions, one of the following: 1. lacunar infarction lesions with a diameter larger than 2 cm greater than 2, or HIS total score> 4 points; 2. lacunar infarction lesion in vital sites, such as thalamus, hippocampus, entorhinal cortex, paraolfactory cortex, cortex and other subcortical gray matter nuclei; 3. white matter damage Fazekas Scale classification = 3; Dementia due to other causes: vascular dementia, central nervous system infection (e.g. AIDS, syphilis), Creutzfeldt-Jakob disease, Huntington's chorea, Parkinson's disease, dementia with Lewy bodies, traumatic dementia, other physical and chemical factors (e.g. drug poisoning, alcoholism, carbon monoxide poisoning), significant physical illness (e.g. hepatic encephalopathy, pulmonary encephalopathy), intracranial occupying lesion (e.g. subdural hematoma, brain tumor), endocrine disorders (e.g. thyroid disease, parathyroid disease) and dementia caused by vitamin B12,folic acid deficiency or other factors; 4. Previous nervous system disorders (including stroke, optic neuromyelitis, Parkinson's disease, epilepsy); 5. Mental illness, according to DSM-V criteria, including schizophrenia or other mental illness, bipolar disorder, major depression or delirium; 6. Abnormal laboratory values: liver function (ALT, AST)> 2 times of upper limit of normal, Cr> 1.5 times of upper limit of normal,creatine kinase> 2 times of upper limit of normal; 7. Uncontrollable hypertension or hypotension in screening: systolic BP =180 mmHg or <90 mmHg, or diastolic BP =120 mmHg or <60 mmHg; the investigator concludes that systolic or diastolic BP is slightly beyond this range but is not clinically significant should not be ruled out; 8. resting heart rate <50 bpm; 9. Hypoglycemic coma occurred in the first 6 months before screening; 10. Diabetic patients in the first 6 months before screening blood glucose control instability, the researchers judged not suitable for participating in this study; 11. within 3 monthes prior to screening of this study,subjects who with newly diagnosed or ongoing unstable or severe heart, lung, liver, kidney, hematopoietic disorders and do not have clinical research conditions; 12. Highly allergic constitution , non-allergic drug reactions or a history of multiple drug allergic 13. Patients with dyspepsia, esophageal reflux, gastric hemorrhage or peptic ulcer disease within 6 months prior to screening, heartburn recurring (= 1 weekly), or any surgical procedure that may affect drug absorption (eg, gastric partial / total resection, small bowel partial / total resection, cholecystectomy); 14. Alcohol abuse or drug abuse; 15. Ant-HIV and Ant-TP were positive; 16. Within 3 monthes prior to screening of this study,patients take thiamine (vitamin B1) and its derivatives, analogues; 17. Within 3 monthes prior to screening of this study,patients take Cholinease inhibitors other than donepezil hydrochloride, N-methyl-D-aspartate receptor antagonists (NMDA antagonists), nootropic drugs, antiparkinson drugs, Opioid analgesics; 18. Visual or hearing disorder, preventing completion of neuropsychological test and scale evaluation; 19. Pregnant, nursing women or unable to take effective contraceptives or subjects with fertility plans; 20. Participate in another clinical trial within 3 monthes prior to initiation of this study; 21. Investigators consider subjects can not complete this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Alzheimer's Disease Assessment Scale-cognitive subscale(ADAS-cog)/11; | — |
Secondary
| Measure | Time frame |
|---|---|
| Alzheimer's Disease Cooperative Study/Activities of Daily; | — |
Countries
China
Contacts
Public ContactWei Cao
Shanghai Rixin Biological Co.,Ltd
Outcome results
None listed