Mild to moderate Alzheimer's disease
Conditions
Interventions
Group 1:Recombinant human serum albumin injection 20g/day every 3 weeks by IV infusion
Group 2:Recombinant human serum albumin injection 30g/day every 3 weeks by IV infusion
Group 3:Recombinant human serum albumin injection 40g/day every 3 weeks by IV infusion
Sponsors
Shanghai Mental Health Center,
Eligibility
Sex/Gender
All
Age
50 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1) Age 50-85 (inclusive of 50 and 85 years old), regardless of gender; 2) Meet the 2011 National Institute on Aging and Alzheimer's Disease Association (NIA-AA) diagnostic criteria for "probable AD dementia". 2) Meet the 2011 National Institute on Aging and Alzheimer's Association (NIA-AA) "probable AD" diagnostic criteria 3) Patients with mild to moderate disease, i.e., Clinical Dementia Rating Scale (CDR-GS) score of <=2; 4) Hachinski Index of Ischemia Scale (HIS) score <= 4 points; 5) Geriatric Depression Scale (GDS) score of 0-10 (including borderline values); 6) Memory loss of at least 12 months with a progressive worsening trend; 7) Screening with a qualifying cranial MRI slice within 1 month or with a cranial MRI scan and oblique coronal hippocampal scan: fewer than or equal to 2 infarct foci greater than 2 cm in diameter, no infarct foci in key areas such as thalamus, hippocampus, internal olfactory cortex, parafrontal olfactory cortex, angular gyrus, cortex, and other subcortical gray matter nuclei, and the highest likelihood of Alzheimer's disease on MRI (medial temporal lobe atrophy). Visual Rating Scale [MTA] classification of greater than or equal to 2); 8) Female patients who are menopausal (menopausal for at least 24 weeks), or surgically sterilized, or females of childbearing potential and males of childbearing potential agree to use effective contraception for the duration of the trial. Females of childbearing potential or patients who have been menopausal for less than 24 weeks must have a negative pregnancy test during the Screening Period; 9) If the patient is receiving AD therapeutic medications such as cholinesterase inhibitors, glutamate receptor antagonists, and glycopyrrolate sodium capsules prior to the Screening Period, or if the patient is using other medications that may affect cognitive function, such as ginkgo biloba, ginaldo, vitamin E, selegiline, folic acid, estrogens, Chinese herbal medicines and compounded sea serpent capsules, Hidradecan, piracetam, and aniracetam, etc., it is required that the patient be kept on a stable dosage for a period of at least 30 days prior to the screening period. The patient must have been on a stable dose for at least 30 days prior to Screening, as determined by the investigator to be appropriate, and the patient is willing to remain on a stable dose for the duration of the trial; 10) The patient has a stable and reliable caregiver, or at least can be adequately cared for (at least 4 days per week, at least 2 hours per day), who is willing to help the patient participate in the trial, including accompanying him/her to visits and assisting in the scoring of relevant scales; 11) The patient has elementary school education or above, and has the ability to complete the cognitive ability measurement and other tests specified in the protocol; 12) Signed informed consent.
Exclusion criteria
Exclusion criteria: 1) Other causes of dementia: frontotemporal lobe dementia, dementia with Lewy bodies, vascular dementia, dementia due to Parkinson's disease, dementia due to epilepsy, dementia due to craniocerebral injuries, dementia due to CNS infections and immune-related dementia; 2) Persons with a known history of allergy/allergic reaction to yeast or yeast-derived products, or to any component of the study preparation; allergy (multiple drug or food allergies), or a history of allergy to biologics, a history of severe systemic allergic reactions from other causes and who, in the judgment of the investigator, are not suitable for treatment with the test drug; 3) Active cardiovascular disease or history of cardiovascular disease at the time of screening, or other conditions that, in the judgment of the investigator, make treatment with human albumin inappropriate, including, but not limited to, hypertension (systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg unless, in the judgment of the investigator, it is well controlled with medication and is stable), severe anemia, acute cardiac disease, serious heart, lung or structural heart disease, serious Arrhythmia, decompensated heart failure (normovolemic or hypervolemic), unstable angina pectoris, myocardial infarction within the last 6 months prior to Screening, tachycardia/bradycardia requiring medication, third degree AV block; 4) Presence of active metabolic disease or history of active metabolic disease at Screening, or comorbid renal impairment that, in the judgment of the Investigator, makes him/her unsuitable to receive serum albumin therapy; 5) Presence of a serious underlying medical condition at the time of screening that, in the judgment of the investigator, makes participation in this study inappropriate, including, but not limited to, active malignancy, pulmonary edema, hemorrhagic tendencies or active bleeding disorders, uncontrolled infections (including active spontaneous bacterial peritonitis), abnormal thyroid function (according to the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE], version 5.0, grade 3 grade and above), etc; 6) Positive Hepatitis B Surface Antigen (HBs Ag) or positive Hepatitis B Core Antibody (HBc Ab) with quantitative Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) above the lower limit of detection, or positive Hepatitis C Antibody (HCV-Ab) with Hepatitis C Virus Ribonucleic Acid (HCV-RNA) above the lower limit of detection at the time of Screening or positive Human Immunodeficiency Virus Ab or positive Syphilis. Ab) positive, or syphilis spirochete (TP) antibody positive; 7) Abnormal laboratory markers are present at the time of screening to the following extent: ? Liver function: alanine aminotransferase (ALT) > 3 x upper limit of normal (ULN); aspartate aminotransferase (AST) > 3 x ULN; serum bilirubin (TBIL) > 1.5 x ULN or in the judgment of the investigator, unsuitable for trial participation; ? Renal function: creatinine clearance (Ccr) <50 mL/min (Ccr was calculated using the Cockcroft-Gault formula Ccr: Ccr(mL/min)=[(140-age)×body weight (kg)]/[72×Scr(mg/dL)], for females, as calculated × 0.85); ? Bone marrow function: absolute neutrophil count (ANC) <1.5x10^9/L; platelet (PLT) <100x10^9/L; hemoglobin (HGB) <90g/L 8) Neurological disorders such as stroke, optic neuromyelitis optica, Parkinson's disease, epilepsy, etc. at screening or at previous screening; 9) Patients with comorbid psychiatric
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AD Assessment Scale-Cognitive subscale (ADAS-Cog) scores; | — |
Secondary
| Measure | Time frame |
|---|---|
| ADAS-Cog scores ;Clinical Dementia Scale-total score (CDR-GS) scores ;Neuropsychiatric inventory (NPI) scores ;AD Collaborative Study Activities of Daily Living (ADCS-ADL) Ability Assessment scale scores ;the concentration and quality of albumin in blood;the concentration and quality of albumin in cerebrospinal fluid ; | — |
Countries
China
Contacts
Public ContactLi Xia
Shanghai Mental Health Center
Outcome results
None listed