Alzheimer disease
Conditions
Interventions
test:IV 260ug/d for two weeks
Sponsors
Tsinghua University Yuquan Hospital
Eligibility
Sex/Gender
All
Age
50 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Met the National Institute on Aging and Alzheimer's Disease Association (NIA-AA) diagnostic criteria for dementia due to probable AD (2011); (2) patients with mild or moderate disease, that is, 11 =MMSE total score =26 (subjects with primary school education 11 =MMSE total score =22); Further participation in the study had to be discussed with the principal investigator if the MMSE score increased or decreased by more than 2 points between baseline and screening. This was done to exclude subjects for whom treatment effects could not be easily distinguished, as well as enrolled patients with possible diagnostic errors. (3) Hakkinsky ischemic Scale (HIS) score =4; 4. Hamilton Depression Scale / 17-item version (HAMD) score =10; (5) memory decline for at least 12 months with a tendency for progressive deterioration; 6. Head MRI examination was performed within 6 months before screening; 7. No obvious neurological signs (except those caused by AD disease or peripheral injury); 8. Women were either postmenopausal (=24 weeks after menopause), had undergone surgical sterilization, or had consented to use effective contraception for the duration of the trial. Women of reproductive age or those with less than 24 weeks of menopause must have a negative urine pregnancy test during screening; 9. Participants should have a stable and reliable caregiver, or at least have frequent contact with a caregiver (at least 2 hours per day, at least 4 days per week), who will help participants participate in the study. Caregivers must accompany the subjects to participate in the study visit 4, and must have sufficient interaction and communication with the subjects to provide valuable information for the scores of NPI, ADCS-ADL, CIBIC-plus and other scales. 10. Subjects should have primary school education or above and be able to complete the cognitive ability test and other tests specified in the protocol; 11. Subjects must provide written informed consent before performing procedures or examinations related to the protocol. If the subjects could not sign because of limited cognitive ability or other reasons, they were allowed to leave the signature blank and explain the reason, and the legal guardian was required to sign the reason explanation, and the legal guardian was required to sign the informed consent. 12. Age: 50-85 years old.
Exclusion criteria
Exclusion criteria: 1. At the time of screening, CT or MRI examination showed significant focal lesions, moderate to severe white matter lesions, and the presence of critical areas such as colliculus Lacunar infarcts in brain, hippocampus, entorhinal cortex, parorhinal cortex, cortex and other subcortical gray matter nuclei; 2. Dementia caused by other causes: vascular dementia, central nervous system infection (such as AIDS, syphilis, etc.), Creutzfeldt-Jakob Alzheimer's disease, Huntington's disease and Parkinson's disease, dementia with Lewy bodies, traumatic cerebral dementia, other physical and chemical factors (e.g Poisoning, alcohol poisoning, carbon monoxide poisoning, etc.), important physical diseases (such as hepatic encephalopathy, pulmonary encephalopathy, etc.), intracranial Space-occupying lesions (such as subdural hematoma, brain tumor), endocrine system lesions (such as thyroid disease, parathyroid disease Disease) and dementia due to vitamins or any other cause; 3. History of neurological diseases (including stroke, neuromyelitis optica, Parkinson's disease, epilepsy, etc.); 4. Psychiatric patients, according to DSM-5 criteria, including schizophrenia or other psychiatric disorders, bipolar disorder, severe Severe depression or delirium; 5. Abnormal laboratory indicators: two pairs of hepatitis B surface antigen HBsAg and hepatitis Be antigen HBeAg and Or the hepatitis B core antibody HbcAb is positive and the hepatitis is in the active stage, and the liver function (ALT, AST) is above the upper limit of normal range 1.2 times, Cr above the upper limit of normal, white blood cell count < 4.0×109 or platelet < 100×109, hemoglobin < 100g/L, glycosylated hemoglobin A1c (HbA1c) =10% or random blood glucose =13.9; 6. Systolic blood pressure =160mmHg or < 90mmHg, or diastolic blood pressure =100mmHg or < 60 MMHG at screening; 7. Have unstable or severe heart, lung, liver, kidney, hematopoietic system diseases (including unstable angina pectoris, uncontrollable) Asthma, active gastric bleeding, cancer, mechanical intestinal obstruction, history of bone marrow transplantation, etc.), resting heart rate after 10 minutes of rest < 60 beats/min, with ECG abnormalities judged by the investigator to be unsuitable for enrollment; 8. Uncorrectable visual and hearing impairment can not complete neuropsychological tests and scale evaluation; 9. Current use of Alzheimer's disease drugs that cannot be stopped; 5 10. Was unable to receive the trial drug as prescribed during screening, had an allergy to the drug, or had nonadherence The possibility that the trial required medication; 11. Alcohol or drug abusers; 12. Pregnant or lactating women; 13. Had participated in another clinical trial within 30 days before the study screening visit; 14. The researcher thought that the subject could not complete the study; 15. Participants were study investigators and their immediate family members or employees and immediate family members of the sponsor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ADAS-Cog;Incidence rate and severity of adverse events;Incidence of clinically significant symptoms, signs, and abnormal laboratory test results;Plasma concentrations of NFL and TDP43 proteins; | — |
Secondary
| Measure | Time frame |
|---|---|
| CIBIC-plus;ADCS-ADL;NPI;ADAS-Cog/12;CIBIC-plus; | — |
Countries
china
Contacts
Public ContactLiyan Qiao
Tsinghua University Yuquan Hospital
Outcome results
None listed