NCT03184467

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

A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Design, Prospective, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Donepezil and Combined With GV1001 in Alzheimer Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: GemVax & Kael · Industry
• Sex: All
• Age: 55 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

GV1001 0.56 mg, 1.12 mg or placebo is subcutaneously administered once weekly schedule for 4 weeks (4 times) followed by every two weeks until week 24 (10 times). A total number of administration is 14 times. 1. Control group (placebo): 30 subjects 2. Study group 1 (GV1001 0.56 mg): 30 subjects 3. Study group 2 (GV1001 1.12 mg): 30 subjects.

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DRUG	Normal Saline 0.9%	Normal saline 0.9% is subcutaneously administered once weekly schedule for 4 weeks (4 times) followed by every two weeks until week 24 (10 times). A total number of administration is 14 times.
DRUG	GV1001 0.56 mg	GV1001 0.56 mg is subcutaneously administered once weekly schedule for 4 weeks (4 times) followed by every two weeks until week 24 (10 times). A total number of administration is 14 times.
DRUG	GV1001 1.12 mg	GV1001 1.12 mg is subcutaneously administered once weekly schedule for 4 weeks (4 times) followed by every two weeks until week 24 (10 times). A total number of administration is 14 times.

Timeline

• Start date: 2017-09-05
• Primary completion: 2019-09-05
• Completion: 2019-09-19
• First posted: 2017-06-12
• Last updated: 2020-07-09

Locations

1 site across 1 country: South Korea