Not Yet RecruitingPhase 3

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

750 participantsStarted 2027-07

Plain-language 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).

Who can participate

Age range

55 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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
. 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

Exclusion criteria

. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is testing a drug called GV1001 given by subcutaneous injection for moderate to severe Alzheimer's — is my loved one's current stage of Alzheimer's the right match for what this trial is looking for?
2Since this is a Phase 3 trial, what do we already know about GV1001's safety and effectiveness from earlier studies, and how does that compare to treatments my loved one is already on or could start now?
3The trial lists its status as 'not yet recruiting' — do you have any idea when it might open for enrollment, and is it worth waiting for this, or would starting an available treatment sooner be a better approach?
4The trial measures cognitive changes using a tool called the SIB over 24 weeks — given where my loved one is right now, is a 24-week study period long enough to know if this treatment is actually making a meaningful difference for someone at their stage?
5What would my loved one need to give up or pause in terms of current Alzheimer's medications or care routines in order to participate in this trial, and could that gap in treatment carry any real risks?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from baseline in SIB(Severe Impairment Battery) score after GV1001 administration for 24 weeks

Timeframe: Baseline, Week 26

CIBIC-plus (Clinician Interview-Based Impression of Change-Plus) score after GV1001 administration for 24 weeks

Timeframe: Baseline, Week 26

Trial details

NCT IDNCT05303701

SponsorSamsung Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-01

Contact for this trial

Kyounghee Seo

+82 31 353 6681 khseo@sspharm.co.kr

View on ClinicalTrials.gov More Moderate to Severe Alzheimer's Disease trials