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

Plain English Summary

GV1001 Subcutaneous for the Treatment of Moderate to Severe Alzheimer's Disease(AD) is a Phase 3 clinical trial sponsored by Samsung Pharmaceutical Co., Ltd. studying Moderate to Severe Alzheimer's Disease. Tests GV1001, a new subcutaneous treatment, for moderate to severe Alzheimer's disease. For patients aged 55-85 with confirmed Alzheimer's disease and cognitive impairment. Participation involves weekly clinic visits and cognitive tests over 26 weeks. Alternatives include other Alzheimer's medications like donepezil and memantine. The trial aims to enroll 750 participants.

Official 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

Here is what you need to know about eligibility for this trial. Ages 55-85, confirmed Alzheimer's disease, cognitive impairment, no other causes of dementia. No vascular dementia, Parkinson's, or other neurological diseases. No significant psychiatric illness or history of seizures. No serious liver or kidney issues, no recent cancer or alcohol/drug abuse. This trial is studying Moderate to Severe Alzheimer's Disease, so participants generally need a confirmed diagnosis.

What They're Measuring

Measures include cognitive function and daily living abilities, helping patients track improvements. The specific primary outcome measures are: Change from baseline in SIB(Severe Impairment Battery) score after GV1001 administration for 24 weeks (Baseline, Week 26); CIBIC-plus (Clinician Interview-Based Impression of Change-Plus) score after GV1001 administration for 24 weeks (Baseline, Week 26). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.

Why This Trial Matters

This trial aims to fill a gap in treatment options for severe Alzheimer's, offering a new subcutaneous therapy. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Moderate to Severe Alzheimer's Disease, where improved treatment options are needed.

Investor Insight

Addresses a large market, with a competitive landscape and potential for approval based on efficacy. Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage. The large enrollment target of 750 participants suggests significant investment in this program.

Is This Trial Right for Me?

Ask your doctor about your eligibility and the potential benefits of GV1001. Participation involves weekly clinic visits and cognitive tests over 26 weeks. The trial is being conducted at multiple sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: QUADRUPLE
• Enrollment: 750 participants

Interventions

• DRUG: GV1001 Placebo — 0.9% normal saline
• DRUG: GV1001 1.12mg — Lyophilized peptide from hTERT

Primary Outcomes

• Change from baseline in SIB(Severe Impairment Battery) score after GV1001 administration for 24 weeks (Baseline, Week 26)
• CIBIC-plus (Clinician Interview-Based Impression of Change-Plus) score after GV1001 administration for 24 weeks (Baseline, Week 26)

Secondary Outcomes

• 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)

Full Eligibility Criteria

Inclusion Criteria:

1. Subjects aged ≥ 55 to ≤ 85 years
2. Subjects who satisfy diagnostic criteria for dementia in DSM-IV (Diagnostic and Statistical Manual of Mental Disorders Fourth edition)
3. 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
4. Subjects with a K-MMSE (Korea Mini-Mental State Examination) score ≤ 19 at the screening visit
5. Subjects with GDS (Global Deterioration Scale) grade 5 to 6
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
7. 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
8. Subjects who are not illiterate
9. Subjects who can walk with or without assist device to visit hospitals or clinics to undergo cognitive tests and other tests
10. 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
11. Subjects and/or legal representative who voluntarily agreed in written to participate in the clinical trial

Exclusion Criteria:

1. 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.
2. 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
3. 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
4. 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
5. 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.).
6. Subjects who are hypersensitive to the components of the investigational product.
7. Subjects with a history of alcohol and drug abuse or dependence (except nicotine dependence) within the last 2 years.
8. 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)
9. Subjects with renal dysfunction (Creatinine Clearance (Clcr) \< 30 mL/min)
10. Subjects with serious hepatic dysfunction (Alanine aminotransferase or Aspartate aminotransferase ≥ 2.0 normal upper limit)
11. 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.
12. Subjects with previous administration of all clinical trial vaccines for Alzheimer's disease
13. 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, 

Frequently Asked Questions

Related Conditions

• Alzheimer's disease, dementia, cognitive impairment, neurodegenerative diseases, elderly care

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