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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.
Details
| Lead sponsor | Protgen Ltd |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | ACTIVE_NOT_RECRUITING |
| Enrolment | 30 |
| Start date | 2024-06-28 |
| Completion | 2026-12 |
Conditions
- Alzheimer's Disease (AD)
Interventions
- Recombinant Human Serum Albumin
Primary outcomes
- 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
Countries
China