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

NCT05303701 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: GV1001-AD-CL3-S002
• Study Type: interventional
• Target: 750
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Moderate to Severe Alzheimer's Disease

Keywords

Alzheimer's Disease; GV1001

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline, Week 26

Secondary Outcomes (7)

• Change from baseline in SIB(Severe Impairment Battery) score

  Baseline, Week 6, and Week 14

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

  Baseline, Week 6, and Week 14

• Change from baseline in K-MMSE(Korea Mini-Mental State Examination) score after GV1001 administration

  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

  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

  Baseline, Week 6 week, Week 14, and Week 26

Other Outcomes (9)

• Exploratory Assessment

  28, 36, and 48 weeks after administration of IP

• Exploratory Assessment

  28, 36, and 48 weeks after administration of IP

• Exploratory Assessment

  28, 36, and 48 weeks after administration of IP

Study Arms (2)

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).

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.

Drug: GV1001 Placebo; Drug: GV1001 1.12mg

Interventions

GV1001 1.12mg DRUG

Lyophilized peptide from hTERT

Also known as: Tertomotide 1.68mg

GV1001 1.12 mg; GV1001 Placebo

GV1001 Placebo DRUG

0.9% normal saline

Also known as: Normal saline

GV1001 1.12 mg; GV1001 Placebo

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Samsung Pharmaceutical Co., Ltd.: lead

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Kyounghee Seo

  Samsung Pharmaceutical Co., Ltd.

  STUDY DIRECTOR

Central Study Contacts

Kyounghee Seo

CONTACT

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

Soyoung Park

CONTACT

+82 70 4840 9243; soyoung@sspharm.co.kr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2022
• First Posted: March 31, 2022
• Study Start (Estimated): July 1, 2027
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): July 1, 2031
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share