An Open-label, Parallel-group Exploratory Clinical Trial to Evaluate the Safety and Preliminary Efficacy of Recombinant Human Serum Albumin Injection in the Treatment of Mild to Moderate Alzheimer's Disease
This clinical trial is an open-label, parallel-group, exploratory study of recombinant human serum albumin (rHSA, hereafter referred to as the investigational drug) in patients with mild to moderate Alzheimer's Disease (AD). It aims to enroll 30 subjects who meet the 2011 National Institute on Aging and Alzheimer's Association (NIA-AA) criteria for Probable AD Dementia. Participants will be randomized in a 1:1:1 ratio to receive the investigational drug at doses of 20g, 30g, or 40g, for assessments of safety and preliminary efficacy. Stratification factors will be based on the severity classification (mild; moderate) as indicated by the total score on the Clinical Dementia Rating Scale - Global Score (CDR-GS) during the screening period.
• Aged between 50 and 85 years (inclusive), with no gender restrictions;
• Meet the 2011 National Institute on Aging and Alzheimer's Association (NIA-AA) criteria for Probable AD Dementia;
• Mild to moderate disease stage, as indicated by a Clinical Dementia Rating Scale - Global Score (CDR-GS) ≤ 2;
• Hachinski Ischemia Scale (HIS) ≤ 4;
• Geriatric Depression Scale (GDS) score between 0 and 10 (inclusive);
• Memory impairment present for at least 12 months with evidence of progression;
• Availability of a qualified brain MRI scan within 1 month prior to enrollment, or willingness to undergo an MRI scan, showing: No more than 2 infarcts larger than 2 cm, no infarcts in key areas such as the thalamus, hippocampus, entorhinal cortex, perirhinal cortex, angular gyrus, cortical or subcortical gray matter nuclei, and imaging features highly suggestive of Alzheimer's Disease (Medial Temporal Lobe Atrophy \[MTA\] scale rating ≥ 2);
• Female participants must be postmenopausal for at least 24 weeks, have undergone sterilization surgery, or if of childbearing potential, along with fertile males, agree to use effective contraception during the study. Women of childbearing potential or those postmenopausal for less than 24 weeks require a negative pregnancy test at screening;
• If patients were on Alzheimer's medications such as cholinesterase inhibitors, NMDA receptor antagonists, or Oligomannate capsules, or taking other drugs that could affect cognition (e.g., Ginkgo biloba, Ginkgo leaf extract, Vitamin E, Selegiline, Folic acid, Estrogen, traditional Chinese medicines including compound sea snake capsules, Citicoline, Piracetam, Aniracetam, etc.), they must have been on a stable dose for at least 30 days before screening, with the investigator determining suitability and the patient agreeing to maintain this stable dose throughout the trial;
⁃ Patients must have a stable and dependable caregiver or adequate care arrangements (a minimum of 4 days weekly, 2 hours daily), with the caregiver willing to assist in the patient's full participation in the trial, including accompanying them to visits and helping with assessment scales;
⁃ Patients should have an educational level of primary school completion or above, capable of completing cognitive assessments and other tests as required by the protocol;
⁃ Written informed consent obtained.