drugset / Trial / NCT03959553

GV1001 Subcutaneous(SC) for the Treatment of Moderate Alzheimer's Disease (AD)

NCT03959553 ↗

Phase 2 Withdrawn GemVax & Kael
RandomizedParallel-groupQuadruple-blindTreatment

Summary

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 moderate Alzheimer's disease (AD). GV1001 has been shown to inhibit neurotoxicity, apoptosis, and the production of reactive oxygen species induced by amyloid beta 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 has been shown to improve cognitive function and memory, as well as significantly reduce the amount of amyloid beta and tau proteins. The multifunctional effect of GV1001 makes it a promising therapeutic option for the treatment for AD.

Timeline

Start
2019-09-01
Primary completion
2021-08-31
Completion
2022-02-28

Outcome

Outcome not reported

Stopped: “The study was stopped due to protocol amendment and project name change.”

Drugs

EvaluationDrugModalityDoseRoute
Subject TERTOMOTIDE Vaccine 0.56 mg Subcutaneous
Subject TERTOMOTIDE Vaccine 1.12 mg Subcutaneous

Indications