A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Design, Prospective, 52-Week, Phase 2 Clinical Study to Evaluate the Safety and Efficacy of GV1001 Administered Subcutaneously for the Treatment of Mild to Moderate Alzheimer's Disease

Alzheimer's Disease

1. Change from baseline in ADAS-Cog11 score at Week 52, 2. Adverse events (AEs), laboratory test results (hematology, serum chemistry, and urinalysis), ECG findings, and vital signs measurements (pulse rate, blood pressure, respiratory rate, body temperature). Suicidal ideation and behavior will be assessed using the Columbia-Suicide Severity Rating Scale (C-SSRS)

Secondary efficacy endpoints: • Clinical worsening, defined as ≥4 points change from baseline in the ADAS-cog11 score at Week 12, Week 26, Week 38, and Week 52, • Change from baseline in A-IADL-Q score at Week 12, Week 26, Week 38 and Week 52, • Change from baseline in NPI score at Week 12, Week 26, Week 38, and Week 52, • Change from baseline in MMSE score at Week 12, Week 26, Week 38, and Week 52, • Change from baseline in CDR-SB score at Week 12, Week 26, Week 38, and Week 52, • Change from baseline in ADCS-CGIC/CIBIC-Plus score at Week 12, Week 26, Week 38, and Week 52, • Change from baseline in QoL-AD score at Week 26 and Week 52

No related papers found yet.

Papers published before 2007-09-01 may not appear yet. Historical indexing is in progress.

Finland, France, Italy, Netherlands, Poland, Portugal, Spain