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

Official Summary

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).

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: QUADRUPLE
• Enrollment: 750 participants

Interventions

• DRUG: GV1001 Placebo — 0.9% normal saline
• DRUG: GV1001 1.12mg — Lyophilized peptide from hTERT

Primary Outcomes

• Change from baseline in SIB(Severe Impairment Battery) score after GV1001 administration for 24 weeks (Baseline, Week 26)
• CIBIC-plus (Clinician Interview-Based Impression of Change-Plus) score after GV1001 administration for 24 weeks (Baseline, Week 26)

Secondary Outcomes

• Change from baseline in SIB(Severe Impairment Battery) score (Baseline, Week 6, and Week 14)
• CIBIC-plus (Clinician Interview-Based Impression of Change-Plus) score after GV1001 administration (Baseline, Week 6, and Week 14)
• Change from baseline in K-MMSE(Korea Mini-Mental State Examination) score after GV1001 administration (Baseline, Week 6 week, Week 14, and Week 26)
• Change from baseline in ADCS-ADL-severe(Alzheimer's Disease Cooperative Study-Activities of Daily Living scale-severe) score after GV1001 administration (Baseline, Week 6 week, Week 14, and Week 26)
• Change from baseline in CDR-SOB(Clinical Dementia Rating Scale Sum of Boxes) score after GV1001 administration (Baseline, Week 6 week, Week 14, and Week 26)

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