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GV1001 Subcutaneous(SC) for the Treatment of Mild to Moderate Alzheimer's Disease (AD)
NCT05189210 · View on ClinicalTrials.gov ↗
Study 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 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.
Conditions Studied
Interventions
- DRUG GV1001 Placebo
- DRUG GV1001 0.56mg
- DRUG GV1001 1.12mg
Study Locations (20)
Florida
- First Choice Neurology - Aventura Neurologic Associates — Adventura
- Finlay Medical Research Corporation - Greenacres — Greenacres City
- Outpatient Psy Care — Miami
- Finlay Medical Research Corporation - Miami Dade — Miami
- Aqualane Clinical Research — Naples
- Palm Beach Neurological Center — Palm Beach Gardens
- Neurostudies - Port Charlotte — Port Charlotte
- Palm Beach Neurology and Premiere Research Institute — West Palm Beach
Other
- Terveystalo Oulu — Oulu
- Casa di Cura iGEA SpA c/o Casa di Cura Privata del Policlinico — Milan
- Brain Research Centre - Den Bosch — Amsterdam
Georgia
- Accel Research Sites (ARS) - NeuroStudies — Decatur
New Jersey
- Global Medical Institutes - Princeton Medical Institute — Princeton
North Carolina
- Flourish Research - Alzheimer's Memory Center/AMC Research, LLC — Charlotte
Tennessee
- Neurology Clinic - Cordova — Cordova
Midi-Pyrenees
- Hôpital La Grave — Toulouse
Rhône
- Hôpital Pierre Wertheimer — Bron
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 199 participants |
| Start Date | 2022-10-05 |
| Est. Completion | 2025-04-16 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05189210
The ClinicalTrials.gov registry entry for NCT05189210 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 199 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GemVax & Kael, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Mild to Moderate Alzheimer's Disease appearing as the primary indexed condition, and to 3 interventions — of which GV1001 Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05189210 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Florida, Other, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05189210 about?
NCT05189210 is a clinical study titled "GV1001 Subcutaneous(SC) for the Treatment of Mild to Moderate Alzheimer's Disease (AD)". 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...
What is the current status of trial NCT05189210?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 199 participants. The study started on 2022-10-05. Estimated completion is 2025-04-16.
What conditions does trial NCT05189210 study?
This clinical trial studies the following conditions: Mild to Moderate Alzheimer's Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05189210?
The interventions under investigation include: GV1001 Placebo (DRUG), GV1001 0.56mg (DRUG), GV1001 1.12mg (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05189210?
This trial is sponsored by GemVax & Kael, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05189210 being conducted?
This trial has 20 study locations across Florida, Georgia, New Jersey, North Carolina, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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