Clinical Trial to Evaluate the Efficacy and Safety of GV1001 in Alzheimer Patients

Summary

This clinical study is designed as a multi-center, randomized, double-blind, placebo-controlled, parallel design, prospective, phase II clinical trial. An eligible subject who meets inclusion and exclusion criteria is randomly assigned to three groups: study group 1 (GV1001 0.56 mg), study group 2 (GV1001 1.12 mg) or placebo group. A randomized subject is administered either GV1001 or placebo in a total of 14 times and will be evaluated for the efficacy and safety at week of 24.

Timeline

Start

2017-09-05

Primary completion

2019-09-05

Completion

2019-09-19

Publications

• Kwon HS, Koh SH, Choi SH, Jeong JH, Na HR, Lee CN, Yang Y, Lee AY, Lee JH, Park KW, Han HJ, Kim BC, Park J, Lee JY, Lee KY, Kim S. Effects of GV1001 on Language Dysfunction in Patients With Moderate-to-Severe Alzheimer's Disease: Post Hoc Analysis of Severe Impairment Battery Subscales. Dement Neurocogn Disord. 2023 Jul;22(3):100-108. doi: 10.12779/dnd.2023.22.3.100. Epub 2023 Jul 11.
• Koh SH, Kwon HS, Choi SH, Jeong JH, Na HR, Lee CN, Yang Y, Lee AY, Lee JH, Park KW, Han HJ, Kim BC, Park JS, Lee JY, Kim S, Lee KY. Efficacy and safety of GV1001 in patients with moderate-to-severe Alzheimer's disease already receiving donepezil: a phase 2 randomized, double-blind, placebo-controlled, multicenter clinical trial. Alzheimers Res Ther. 2021 Mar 26;13(1):66. doi: 10.1186/s13195-021-00803-w.

Drugs

Indications