GV1001 for Alzheimer's Disease
Trial Summary
Will I have to stop taking my current medications?
If you are taking an approved medication for Alzheimer's disease, you must have been on a stable dose for at least 12 weeks before the study and continue it throughout the study. Some medications like tricyclic antidepressants and MAO inhibitors are not allowed, and the use of anxiolytics, narcotics, or sleep aids should not interfere with cognitive testing.
Is GV1001 safe for humans?
How does the drug GV1001 differ from other Alzheimer's treatments?
What is the purpose of this trial?
The current study is being conducted by the Sponsor to evaluate the efficacy and safety of GV1001 (0.56 mg and 1.12 mg) administered subcutaneously as a treatment for mild to moderate Alzheimer's disease (AD). Studies using in vivo and in vitro AD models have shown that GV1001 inhibits neurotoxicity, apoptosis, and the production of reactive oxygen species induced by amyloid beta (Aβ) in neural stem cells by mimicking the extra-telomeric functions of human telomerase reverse transcriptase (hTERT). In nonclinical studies, using both mild (early stage) and severe (late stage) AD mouse models, GV1001 was shown to improve cognitive function and memory, as well as significantly reduce the amount of Aβ and tau proteins. The multifunctional effect of GV1001 makes it a promising therapeutic option for the treatment for AD. In a completed Phase 2 study conducted in Korea, GV1001 showed significant improvement in change from baseline of Severe Impairment Battery score at Week 24 and demonstrated a clinically acceptable safety profile in patients with moderate to severe AD.
Research Team
Sangjae Kim
Principal Investigator
GemVax & KAEL Co., Ltd.
Eligibility Criteria
This trial is for individuals aged 55-85 with mild to moderate Alzheimer's, as shown by specific memory and cognition tests. They must have had a brain scan within the last two years consistent with Alzheimer's and no other dementia causes. Participants should be on stable Alzheimer's medication for at least three months and not part of another study recently.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive GV1001 or placebo subcutaneously once weekly for 4 weeks, then every 2 weeks through Week 50
End-of-Study (EOS)
Participants undergo final assessments 2 weeks after the last dose of study drug
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- GV1001
Find a Clinic Near You
Who Is Running the Clinical Trial?
GemVax & Kael
Lead Sponsor