GV1001 Subcutaneous for the Treatment of Moderate to Severe Alzheimer's Disease(AD)
Status:
Not yet recruiting
Trial end date:
2026-04-30
Target enrollment:
Participant gender:
Summary
The study will be 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 moderate to severe
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.