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NCT05189210 · ClinicalTrials.gov registry record · Phase 2
GV1001 Subcutaneous(SC) for the Treatment of Mild to Moderate Alzheimer's Disease (AD)
A Phase 2 study of Mild to Moderate Alzheimer's Disease, sponsored by GemVax & Kael.
- Completed
- Registry status
- Phase 2
- Development phase
- 199
- Enrollment target
- 20
- Study locations
NCT05189210: Completed Phase 2 study of Mild to Moderate Alzheimer's Disease, sponsored by GemVax & Kael.
NCT05189210 is a Phase 2 study of Mild to Moderate Alzheimer's Disease that has completed, run by GemVax & Kael. The registered enrollment target is 199 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05189210, a Phase 2 study of Mild to Moderate Alzheimer's Disease, has completed, sponsored by GemVax & Kael.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 199 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
The Alzheimer's Disease Assessment Scale (ADAS) consists of 2 parts, a cognitive subscale and a behavioral subscale. The 11-item cognitive subscale (ADAS-cog) of the ADAS instrument will be used in this study. The ADAS-cog11 is a widely accepted performance-based assessment of cognition used in clinical studies for the treatment of participants with AD. The ADAS-cog11 (score range) consists of word recall (0-10) and word recognition memory tests (0-12), object and finger naming (0-5), commands
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 |
What the finished NCT05189210 record still lists
NCT05189210 is an interventional study that assigns participants to a tested intervention. The registered 199 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% higher).
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.
NCT05189210 names 20 study sites across 11 states, led by Florida, Other, Georgia.
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.
What interventions are being tested in trial NCT05189210?
The interventions under investigation include: GV1001 Placebo (DRUG), GV1001 0.56mg (DRUG), GV1001 1.12mg (DRUG).
Who is sponsoring clinical trial NCT05189210?
This trial is sponsored by GemVax & Kael, which has 1 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT05189210's enrollment target sits among peer trials
199 349th of 2000 higher than 1,652 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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