GV1001 Subcutaneous(SC) for the Treatment of Mild to Moderate Alzheimer's Disease (AD)
Public ClinicalTrials.gov record NCT05189210. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Prospective, 52-Week, Phase 2 Clinical Study to Evaluate the Safety and Efficacy of GV1001 Administered Subcutaneously for the Treatment of Mild to Moderate AD
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05189210
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 199 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 55 Years to 85 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 4, 2022
- Primary completion
- Apr 2, 2025
- Completion
- Apr 15, 2025
- Last update posted
- Sep 3, 2025
2022 – 2025
United States locations
- U.S. sites
- 12
- U.S. states
- 5
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| First Choice Neurology - Aventura Neurologic Associates | Adventura | Florida | 33180 | — |
| Finlay Medical Research Corporation - Greenacres | Greenacres City | Florida | 33467 | — |
| Outpatient Psy Care | Miami | Florida | 33125 | — |
| Finlay Medical Research Corporation - Miami Dade | Miami | Florida | 33126 | — |
| Aqualane Clinical Research | Naples | Florida | 34105 | — |
| Palm Beach Neurological Center | Palm Beach Gardens | Florida | 33410 | — |
| Neurostudies - Port Charlotte | Port Charlotte | Florida | 33952 | — |
| Palm Beach Neurology and Premiere Research Institute | West Palm Beach | Florida | 33407 | — |
| Accel Research Sites (ARS) - NeuroStudies | Decatur | Georgia | 30033 | — |
| Global Medical Institutes - Princeton Medical Institute | Princeton | New Jersey | 08540 | — |
| Flourish Research - Alzheimer's Memory Center/AMC Research, LLC | Charlotte | North Carolina | 28270 | — |
| Neurology Clinic - Cordova | Cordova | Tennessee | 38018 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 23 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05189210, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 3, 2025 · Synced Sep 5, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05189210 live on ClinicalTrials.gov.