Recombinant Human Serum Albumin in the Treatment of AD (Alzheimer Disease) Exploratory Clinical Trials
NCT Number: NCT06489015
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Alzheimer's Disease (AD)
Interventions: DRUG: Recombinant Human Serum Albumin
Sponsor: Protgen Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-28
Completion Date: 2025-12
Locations: Shanghai Mental Health Center, Shang'ai, China

Summary:
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.

Primary Outcome Measures: The change in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) score from baseline to Week 25 post-treatment., from baseline to Week 25 post-treatment
Secondary Outcome Measures: The changes in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) scores from baseline at Weeks 7, 16, 29 (if applicable), 37 (if applicable), and 41 (if applicable) post-treatment., The Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) is an instrument used to assess cognitive function in individuals with Alzheimer's disease or other forms of dementia. The scale ranges from 0 to 70, with lower scores indicating better cognitive function and higher scores indicating more severe cognitive impairment. Therefore, the lower the score on the ADAS-Cog, the better the cognitive performance of the individual being assessed. Conversely, a higher score indicates greater cognitive decline. The minimum possible score on the ADAS-Cog is 0, and the maximum possible score is 70., At Weeks 7, 16, 25, 29 (if applicable), 37 (if applicable), and 41 (if applicable)|The changes in Clinical Dementia Rating Scale - Global Score (CDR-GS) from baseline at Weeks 7, 16, 25, 29 (if applicable), 37 (if applicable), and 41 (if applicable) following treatment initiation., The Clinical Dementia Rating - Global Score (CDR-GS) is a tool used by healthcare professionals to assess the severity of dementia in patients. The CDR-GS has a range from 0 to 3, with 0 representing no dementia, 0.5 indicating very mild dementia, 1 indicating mild dementia, 2 indicating moderate dementia, and 3 indicating severe dementia.

Therefore, the lower the score on the CDR-GS, the better the cognitive and functional abilities of the individual being assessed. Conversely, a higher score indicates more severe dementia. The minimum possible score on the CDR-GS is 0, and the maximum possible score is 3., At Weeks 7, 16, 25, 29 (if applicable), 37 (if applicable), and 41 (if applicable)|The changes in Neuropsychiatric Inventory (NPI) scores from baseline at Weeks 7, 16, 25, 29 (if applicable), 37 (if applicable), and 41 (if applicable) after the commencement of treatment., The Neuropsychiatric Inventory (NPI) is a tool used to evaluate neuropsychiatric symptoms in individuals with dementia. A lower score on the NPI indicates fewer or less severe neuropsychiatric symptoms, while a higher score suggests more frequent or severe symptoms. Thus, a lower NPI score is generally considered to be a better outcome. The minimum possible score is 0, and the maximum possible score is 144., At Weeks 7, 16, 25, 29 (if applicable), 37 (if applicable), and 41 (if applicable)|The changes in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) ability assessment scale scores from baseline, The Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) is a tool designed to measure the functional ability of individuals with Alzheimer's disease. The ADCS-ADL has a range from 0 to 78, where 0 indicates complete dependence and 78 indicates complete independence. Higher scores on the ADCS-ADL indicate better functional status and ability to perform daily activities independently.ng the start of treatment., At Weeks 7, 16, 25, 29 (if applicable), 37 (if applicable), and 41 (if applicable)
Other Outcome Measures: blood albumin concentration, Blood samples were collected and the concentration and quality of albumin in the blood were measured at baseline (D0), 12 hours after the 5th dosing (W13D1), and 12 hours after the 9th dosing (W25D1). Cerebrospinal Fluid (CSF) samples were collected during the treatment period (if CSF samples were obtained from the participants 12 hours after drug administration on W13D1 or W25D1, there was no need for repeated blood sampling)., At baseline (D0), 12 hours after the 5th dosing (W13D1), and 12 hours after the 9th dosing (W25D1)、12 hours following CSF collection|oxidation level of serum albumin, including levels of free thiols, sulfonated residues, carbonylation, glycation, and homocysteinylation，These metrics will be compared against those of albumin from healthy individuals, ultimately deriving a paramete, At baseline (D0), 12 hours after the 5th dosing (W13D1), and 12 hours after the 9th dosing (W25D1)、12 hours following CSF collection|cerebrospinal fluid albumin concentration, In each dose group, CSF (Cerebrospinal Fluid) samples are collected from at least 50% of the participants. The collection times are at baseline (D0) and 12 hours following any dosing event between W13D1 and W25D1 during the treatment period., At baseline (D0) and 12 hours following any dosing event between W13D1 and W25D1 during the treatment period|oxidation level of cerebrospinal fluid (CSF) albumin, including levels of free thiols, sulfonated residues, carbonylation, glycation, and homocysteinylation，These metrics will be compared against those of albumin from healthy individuals, ultimately deriving a paramete, At baseline (D0) and 12 hours following any dosing event between W13D1 and W25D1 during the treatment period