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A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Design, Prospective, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Subcutaneous Administration of GV1001 1.12 mg/Day in Patients With Moderate to Severe Alzheimer Disease
The objective of this study is to evaluate the safety and efficacy of GV1001 administered subcutaneously in patients with moderate to severe Alzheimer's disease (AD).
Details
| Lead sponsor | Samsung Pharmaceutical Co., Ltd. |
|---|---|
| Phase | Phase 3 |
| Status | NOT_YET_RECRUITING |
| Enrolment | 750 |
| Start date | 2027-07 |
| Completion | 2031-07 |
Conditions
- Moderate to Severe Alzheimer's Disease
Interventions
- GV1001 Placebo
- GV1001 1.12mg
Primary outcomes
- Change from baseline in SIB(Severe Impairment Battery) score after GV1001 administration for 24 weeks — Baseline, Week 26
SIB includes 51 questions to assess cognition in an individual. SIB consists of nine symptom domains such as attention, language, orientation, memory, praxis, visuospatial perception, construction, social skills and orientating head to name. The possible total scores range from 0 to 100 with a higher score indicating greater cognitive function. - CIBIC-plus (Clinician Interview-Based Impression of Change-Plus) score after GV1001 administration for 24 weeks — Baseline, Week 26
CIBIC-plus consists of 4 items: "Overall," "Mental and Cognitive Function," "Behavior," and "Daily Function." CIBIS, a 7-point severity assessment, is administered at baseline. CIBIC-plus is implemented at follow-up visits to evaluate the degree of change in overall functional status in 7 levels by referring to the CIBIS results evaluated at baseline. The overall clinical condition of the dementia patient is assessed based on information obtained from semi-structured interviews of patients and caregivers. The rater is independent, has clinical experience, and will evaluate the subjects after completing the training required for this study.