Moderate to Severe Alzheimer's DiseasePhase 3NCT05303701
GV1001 Subcutaneous for the Treatment of Moderate to Severe Alzheimer's Disease(AD)
A Phase 3 study testing GV1001 1.12mg in people with Moderate to Severe Alzheimer's Disease, run by Samsung Pharmaceutical Co., Ltd..
Trial 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). Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Moderate to Severe Alzheimer's Disease
- What is being tested?
- GV1001 1.12mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 750 participants
- Where
- No sites listed yet
- Study dates
- Jul 2027to Jul 2031
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects aged ≥ 55 to ≤ 85 years
- Subjects who satisfy diagnostic criteria for dementia in DSM-IV (Diagnostic and Statistical Manual of Mental Disorders Fourth edition)
- Subjects who are clinically diagnosed with probable Alzheimer's disease as defined in the NINCDS-ADRDA (National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders Association) criteria
- Subjects with a K-MMSE (Korea Mini-Mental State Examination) score ≤ 19 at the screening visit
- Subjects with GDS (Global Deterioration Scale) grade 5 to 6
- Subjects who have no other diseases to cause dementia other than AD as a result of MRI or CT scan within 12 months from the screening visit
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- Subjects who are taking donepezil alone or donepezil and memantine in combination at a stable dose without a dose change over 3 months before screening
- Subjects who are not illiterate
- Subjects who can walk with or without assist device to visit hospitals or clinics to undergo cognitive tests and other tests
- Subjects with caregiver who can accompany all visits with the subjects as scheduled for this trial, supervise subject's compliance for the tests and examination process and provide information about the subject's indications, and who give written consent
- Subjects and/or legal representative who voluntarily agreed in written to participate in the clinical trial
Who cannot join
- Subjects who have other causes of dementia as listed below according to CT/MRI test and neurologic examination within 12 months of screening or at the time of screening.
- Subjects with possible, probable or definite vascular dementia according to NINDS-AIREN (National Institute of Neurological Disorders and Stroke and the Association Internationale pour la Recherche et l'Enseignement en Neurosciences) criteria
- Subjects with other central nervous system diseases that can cause the impairment of cognitive function (cerebrovascular disease including cerebrovascular dementia, Parkinsonism, Huntington's disease, subdural hematoma, normal pressure hydrocephalus, brain tumor, Creutzfeldt-Jakob disease, etc.)
- Subjects with neuropathy such as delusion, delirium, epilepsy, etc.
- Subjects who have abnormal test results which are considered to contribute to the severity of their dementia or be the cause of dementia in the vitamin B12, folic acid, syphilis serology, and the thyroid stimulating hormone (TSH) tests
- Subjects who have a history of significant psychiatric illness such as schizophrenia or bipolar affective disorders which may interfere with the participation of this clinical trial according to the investigator's judgment or who are suffering from depression
Show all 24Show fewer
- Subjects with a history of known or suspected seizures including febrile seizure, recent loss of consciousness which is not explained or history of significant head trauma accompanied by loss of consciousness
- Subjects in any medical condition that may interfere with the evaluation and progression of the clinical trial according to the investigator's judgment (acute or unstable cardiovascular disease, uncontrolled hypertension (>160/100 mmHg) at Visit 1 and Visit 2, insulin-dependent or uncontrolled diabetes at Visit 1 (HbA1c> 8% on screening test), etc.).
- Subjects who are hypersensitive to the components of the investigational product.
- Subjects with a history of alcohol and drug abuse or dependence (except nicotine dependence) within the last 2 years.
- Subjects with a history of cancer within the past 5 years (however, non-metastatic skin basal cell carcinoma and/or skin squamous cell carcinoma, carcinoma in suit of uterine cervix or non-progressive prostate cancer may be acceptable and If cancer is considered to have been treated at the judgement of the investigator, if subjects are not taking anticancer or radiation therapy and are considered that treatment is not required for the next 5 years at the discretion of the investigator, enrollment is possible)
- Subjects with renal dysfunction (Creatinine Clearance (Clcr) < 30 mL/min)
- Subjects with serious hepatic dysfunction (Alanine aminotransferase or Aspartate aminotransferase ≥ 2.0 normal upper limit)
- Subjects currently receiving or expected to receive medications prohibited in this clinical trial during the trial period
- Donepezil, memantine, or other medications for the treatment of Alzheimer's disease (acetylcholinesterase inhibitors (rivastigmine, galantamine), anti-amyloid antibodies (lecanemab, donanemab), etc.) or other medications for the treatment of cognitive impairment.
- Subjects with previous administration of all clinical trial vaccines for Alzheimer's disease
- Among subjects who consented to lumbar puncture (LP) for cerebrospinal fluid (CSF) collection, patients meeting the following criteria
- Patients with contraindications for lumbar puncture (e.g., platelet count <100,000/μL, lumbar deformity, etc.) (However, even if a subject has contraindications for lumbar puncture, they may still participate in this clinical trial.)
- Female subjects with childbearing potential who do not agree to contraception using a medically accepted method (complete celibacy; hormonal contraceptives: Levonorgestrel, Intrauterine system of Mirena, and Medroxyprogesterone; and surgical sterilizations: vasectomy, double tubectomy, double tubal ligation) during the clinical trial period and until 90 days after clinical trial end (stop).
- Pregnant or lactating women
- Subjects who participated in another clinical trial within 4 weeks before participation in this clinical trial
- Subjects in less than 12 months after the administration of the Investigational product for this clinical trial
- Subjects who participated in any clinical trial for Alzheimer type dementia treatment within 6 months at screening
- Subjects who are judged by the investigator to be ineligible for participation in this clinical trial
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Design, Prospective, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Subcutaneous Administration of GV1001 1.12 mg/Day in Patients With Moderate to Severe Alzheimer Disease
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).
Read the detailed description
Studies using in vivo and in vitro Alzheimer's Disease (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 (NCT03184467) 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.
This is a multi-center, randomized, double-blinded, placebo-controlled, parallel design, prospective phase 3 study in participants with moderate to severe AD. The study consists of 24 weeks of Double-blind phase and 25 weeks of open-label phase.
- Conditions
- Moderate to Severe Alzheimer's Disease
- Being tested
- GV1001 Placebo, GV1001 1.12mg
- Keywords
- Alzheimer's Disease, GV1001
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GV1001 PlaceboDrug
Also called Normal saline
0.9% normal saline
GV1001 1.12mgDrug
Also called Tertomotide 1.68mg
Lyophilized peptide from hTERT
| Study group | Role | What they receive |
|---|---|---|
| GV1001 Placebo | Placebo comparator | GV1001 placebo (0.9% saline) subcutaneous injection will be administered once a week for 4 weeks and then administered every 2 weeks for 20 weeks in a double-blind phase.
During the open-label extension phase, patients assigned to the GV1001 Placebo arm in the double-blind phase will receive a placebo in the first week, followed by 1.12 mg of GV1001 weekly for 4 weeks and then every 2 weeks until EOT (End of Treatment). Receives: Drug: GV1001 Placebo; Drug: GV1001 1.12mg |
| GV1001 1.12 mg | Experimental | GV1001 1.12 mg subcutaneous injection will be administered once a week for 4 weeks and then administered every 2 weeks for 20 weeks in a double blind phase.
During the open-label extension phase, patients will alternate between 1.12 mg of GV1001 and placebo weekly for the first 5 weeks to maintain double blindness, and then 1.12mg of GV1001 every 2 weeks until EOT. Receives: Drug: GV1001 Placebo; Drug: GV1001 1.12mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in SIB(Severe Impairment Battery) score after GV1001 administration for 24 weeks
SIB includes 51 questions to assess cognition in an individual. SIB consists of nine symptom domains such as attention, language, orientation, memory, praxis, visuospatial perception, construction, social skills and orientating head to name. The possible total scores range from 0 to 100 with a higher score indicating greater cognitive function.
Measured: Baseline, Week 26
CIBIC-plus (Clinician Interview-Based Impression of Change-Plus) score after GV1001 administration for 24 weeks
CIBIC-plus consists of 4 items: "Overall," "Mental and Cognitive Function," "Behavior," and "Daily Function." CIBIS, a 7-point severity assessment, is administered at baseline. CIBIC-plus is implemented at follow-up visits to evaluate the degree of change in overall functional status in 7 levels by referring to the CIBIS results evaluated at baseline. The overall clinical condition of the dementia patient is assessed based on information obtained from semi-structured interviews of patients and caregivers. The rater is independent, has clinical experience, and will evaluate the subjects after completing the training required for this study.
Measured: Baseline, Week 26
Secondary outcomes (7)
Change from baseline in SIB(Severe Impairment Battery) score
SIB includes 51 questions to assess cognition in an individual. SIB consists of nine symptom domains such as attention, language, orientation, memory, praxis, visuospatial perception, construction, social skills and orientating head to name. The possible total scores range from 0 to 100 with a higher score indicating greater cognitive function.
Measured: Baseline, Week 6, and Week 14
CIBIC-plus (Clinician Interview-Based Impression of Change-Plus) score after GV1001 administration
CIBIC-plus consists of 4 items: "Overall," "Mental and Cognitive Function," "Behavior," and "Daily Function." CIBIS, a 7-point severity assessment, is administered at baseline. And CIBIC-plus is implemented at follow-up visits to evaluate the degree of change in overall functional status in 7 levels by referring to the CIBIS results evaluated at baseline. The overall clinical condition of the dementia patient is assessed based on information obtained from semi-structured interviews of patients and caregivers. The rater is independent, has clinical experience, and will evaluate the subjects after completing the training required for this study.
Measured: Baseline, Week 6, and Week 14
Change from baseline in K-MMSE(Korea Mini-Mental State Examination) score after GV1001 administration
K-MMSE assesses an individual's cognitive function by asking questions about time orientation, spatial orientation, memory registration, attention and calculation, memory recall, language, and space-time configuration. It creates the possible total score from 0 to 30, with a lower total score indicating greater severity in cognitive impairment.
Measured: Baseline, Week 6 week, Week 14, and Week 26
Change from baseline in ADCS-ADL-severe(Alzheimer's Disease Cooperative Study-Activities of Daily Living scale-severe) score after GV1001 administration
ADCS-ADL-severe consists of 19 items that can access the competence of individuals with AD in activities of daily living. The maximum possible total score is 54, with a higher score indicating lesser severity in AD.
Measured: Baseline, Week 6 week, Week 14, and Week 26
Change from baseline in CDR-SOB(Clinical Dementia Rating Scale Sum of Boxes) score after GV1001 administration
CDR-SOB evaluates cognitive and functional performance in six domains related to AD including memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. Each domain is rated from 0 to 5 points (0, 0.5, 1, 2, 3, 4, and 5) with a lower total score indicating severely impaired cognitive function.
Measured: Baseline, Week 6 week, Week 14, and Week 26
Change from baseline in GDS(Global Deterioration Scale) score after GV1001 administration
GDS provides the stages for the severity of cognitive function of the individual with AD. It is brown down into seven stages (stage1=no cognitive decline and 7=very severe cognitive decline).
Measured: Baseline, Week 6 week, Week 14, and Week 26
Change from baseline in NPI-Q(Neuropsychiatric Inventory Questionnaire) score after GV1001 administration
NPI-Q consists of questions to evaluate degrees of behavioral disturbance in 12 domains. It includes delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, nighttime behaviors, and appetite/eating. The severity scale has scores ranging from 1 to 3 points (1=mild and 3=severe) and the scale for assessing caregiver distress has scores ranging from 0 to 5 points (0=no distress and 5=extreme distress). The higher sum of the NPI-Q severity score represents greater severity of the individual's symptoms, and the higher sum of the NPI-Q distress score indicates greater severity of caregiver's distress associated with the symptoms.
Measured: Baseline, Week 6 week, Week 14, and Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study startJul 2027 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionJul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyounghee Seo, Study director, Samsung Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05303701
- Sponsor's protocol ID
- GV1001-AD-CL3-S002
- Status last verified
- Feb 2026
- First submitted
- 15 Mar 2022
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Design, Prospective, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Subcutaneous Administration of GV1001 1.12 mg/Day in Patients With Moderate to Severe Alzheimer Disease
- ClinicalTrials.gov ID
- NCT05303701
- Acronym / sponsor ID
- GV1001-AD-CL3-S002
- Conditions
- Moderate to Severe Alzheimer's Disease
- Keywords
- Alzheimer's Disease, GV1001
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Samsung Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2027 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jul 2031 (estimated)
- First posted
- 31 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Studies using in vivo and in vitro Alzheimer's Disease (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 (NCT03184467) 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.
This is a multi-center, randomized, double-blinded, placebo-controlled, parallel design, prospective phase 3 study in participants with moderate to severe AD. The study consists of 24 weeks of Double-blind phase and 25 weeks of open-label phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GV1001 Placebo | Placebo comparator | Drug: GV1001 Placebo, Drug: GV1001 1.12mgGV1001 placebo (0.9% saline) subcutaneous injection will be administered once a week for 4 weeks and then administered every 2 weeks for 20 weeks in a double-blind phase. During the open-label extension phase, patients assigned to the GV1001 Placebo arm in the double-blind phase will receive a placebo in the first week, followed by 1.12 mg of GV1001 weekly for 4 weeks and then every 2 weeks until EOT (End of Treatment). |
| GV1001 1.12 mg | Experimental | Drug: GV1001 Placebo, Drug: GV1001 1.12mgGV1001 1.12 mg subcutaneous injection will be administered once a week for 4 weeks and then administered every 2 weeks for 20 weeks in a double blind phase. During the open-label extension phase, patients will alternate between 1.12 mg of GV1001 and placebo weekly for the first 5 weeks to maintain double blindness, and then 1.12mg of GV1001 every 2 weeks until EOT. |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subjects aged ≥ 55 to ≤ 85 years
- Subjects who satisfy diagnostic criteria for dementia in DSM-IV (Diagnostic and Statistical Manual of Mental Disorders Fourth edition)
- Subjects who are clinically diagnosed with probable Alzheimer's disease as defined in the NINCDS-ADRDA (National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders Association) criteria
- Subjects with a K-MMSE (Korea Mini-Mental State Examination) score ≤ 19 at the screening visit
- Subjects with GDS (Global Deterioration Scale) grade 5 to 6
Key exclusion criteria (24 listed)
- Subjects who have other causes of dementia as listed below according to CT/MRI test and neurologic examination within 12 months of screening or at the time of screening.
- Subjects who have abnormal test results which are considered to contribute to the severity of their dementia or be the cause of dementia in the vitamin B12, folic acid, syphilis serology, and the thyroid stimulating hormone (TSH) tests
- Subjects who have a history of significant psychiatric illness such as schizophrenia or bipolar affective disorders which may interfere with the participation of this clinical trial according to the investigator's judgment or who are suffering from depression
- Subjects with a history of known or suspected seizures including febrile seizure, recent loss of consciousness which is not explained or history of significant head trauma accompanied by loss of consciousness
- Subjects in any medical condition that may interfere with the evaluation and progression of the clinical trial according to the investigator's judgment (acute or unstable cardiovascular disease, uncontrolled hypertension (>160/100 mmHg) at Visit 1 and Visit 2, insulin-dependent or uncontrolled diabetes at Visit 1 (HbA1c> 8% on screening test), etc.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GV1001 PlaceboAlso: Normal saline0.9% normal saline | Drug | GV1001 1.12 mg, GV1001 Placebo |
| GV1001 1.12mgAlso: Tertomotide 1.68mgLyophilized peptide from hTERT | Drug | GV1001 1.12 mg, GV1001 Placebo |
Primary outcome
Change from baseline in SIB(Severe Impairment Battery) score after GV1001 administration for 24 weeks
Time frame: Baseline, Week 26
SIB includes 51 questions to assess cognition in an individual. SIB consists of nine symptom domains such as attention, language, orientation, memory, praxis, visuospatial perception, construction, social skills and orientating head to name. The possible total scores range from 0 to 100 with a higher score indicating greater cognitive function.
CIBIC-plus (Clinician Interview-Based Impression of Change-Plus) score after GV1001 administration for 24 weeks
Time frame: Baseline, Week 26
CIBIC-plus consists of 4 items: "Overall," "Mental and Cognitive Function," "Behavior," and "Daily Function." CIBIS, a 7-point severity assessment, is administered at baseline. CIBIC-plus is implemented at follow-up visits to evaluate the degree of change in overall functional status in 7 levels by referring to the CIBIS results evaluated at baseline. The overall clinical condition of the dementia patient is assessed based on information obtained from semi-structured interviews of patients and caregivers. The rater is independent, has clinical experience, and will evaluate the subjects after completing the training required for this study.
7 secondary outcomes
Change from baseline in SIB(Severe Impairment Battery) score
Time frame: Baseline, Week 6, and Week 14
CIBIC-plus (Clinician Interview-Based Impression of Change-Plus) score after GV1001 administration
Time frame: Baseline, Week 6, and Week 14
Change from baseline in K-MMSE(Korea Mini-Mental State Examination) score after GV1001 administration
Time frame: Baseline, Week 6 week, Week 14, and Week 26
Change from baseline in ADCS-ADL-severe(Alzheimer's Disease Cooperative Study-Activities of Daily Living scale-severe) score after GV1001 administration
Time frame: Baseline, Week 6 week, Week 14, and Week 26
Change from baseline in CDR-SOB(Clinical Dementia Rating Scale Sum of Boxes) score after GV1001 administration
Time frame: Baseline, Week 6 week, Week 14, and Week 26
Change from baseline in GDS(Global Deterioration Scale) score after GV1001 administration
Time frame: Baseline, Week 6 week, Week 14, and Week 26
Change from baseline in NPI-Q(Neuropsychiatric Inventory Questionnaire) score after GV1001 administration
Time frame: Baseline, Week 6 week, Week 14, and Week 26
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kyounghee Seo study director
Samsung Pharmaceutical Co., Ltd.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GV1001 1.12mg in people with Moderate to Severe Alzheimer's Disease, run by Samsung Pharmaceutical Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kyounghee Seo (+82 31 353 6681, khseo@sspharm.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in SIB(Severe Impairment Battery) score after GV1001 administration for 24 weeks (time frame: Baseline, Week 26). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.