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

NCT05303701 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 750

Last updated 2026-02-23

No results posted yet for this study

Summary

The objective of this study is to evaluate the safety and efficacy of GV1001 administered subcutaneously in patients with moderate to severe Alzheimer's disease (AD).

Conditions

  • Moderate to Severe Alzheimer's Disease

Interventions

DRUG

GV1001 Placebo

0.9% normal saline

DRUG

GV1001 1.12mg

Lyophilized peptide from hTERT

Sponsors & Collaborators

  • Samsung Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Kyounghee Seo · Samsung Pharmaceutical Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-07-31
Primary Completion
2028-01-31
Completion
2031-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05303701 on ClinicalTrials.gov