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Study on the Effects of GV1001 for Patients with Mild to Moderate Alzheimer's Disease

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying Alzheimer's Disease, a condition that affects memory and thinking skills. The study is testing a treatment called GV1001, which is given as an injection under the skin. The main goal of the study is to evaluate how well GV1001 works in improving memory and thinking abilities in people with mild to moderate Alzheimer's Disease, as well as to assess its safety.

Participants in the study will receive either GV1001 at different doses or a placebo. The study will last for 52 weeks, during which participants will have regular check-ups to monitor their health and any changes in their condition. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo, to ensure unbiased results.

Throughout the study, participants will undergo various assessments to track changes in their cognitive abilities, which refers to their memory and thinking skills. These assessments will help determine the effectiveness of GV1001 in treating Alzheimer's Disease. The safety of the treatment will also be closely monitored through regular health checks, including blood tests and other evaluations. The study aims to provide valuable information on the potential benefits and risks of using GV1001 for this condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the participant will be randomly assigned to receive either the study medication, GV1001, or a placebo. This process is double-blind, meaning neither the participant nor the study team will know which treatment is being administered.

  2. Step 2

    Medication administration

    The study medication, GV1001, is administered as an injection under the skin. The dosage will be either 0.56 mg or 1.12 mg, depending on the group assignment.

    Injections are given according to the study schedule, which spans a total of 52 weeks.

  3. Step 3

    Regular assessments

    Throughout the study, participants will undergo regular assessments to monitor cognitive function and overall health. These assessments include tests like the ADAS-cog11, which measures cognitive abilities.

    Additional evaluations will include laboratory tests, ECGs, and vital sign measurements to ensure safety.

  4. Step 4

    Monitoring and follow-up

    Participants will be monitored for any changes in their condition or any side effects from the medication. This includes regular visits to the study center for assessments at specified intervals: Week 12, Week 26, Week 38, and Week 52.

    The study will also track any adverse events or changes in health status.

  5. Step 5

    Completion of the study

    At the end of the 52-week period, participants will undergo a final assessment to evaluate the effects of the treatment.

    The study aims to determine the efficacy and safety of GV1001 in treating mild to moderate Alzheimer's disease.

Who can join the trial?

10 criteria

  • Participants must be between 55 and 85 years old.
  • Participants must have a diagnosis of probable Alzheimer's Disease (AD) based on specific criteria, which includes memory problems that have been getting worse over more than 6 months.
  • Participants must have mild to moderate dementia, shown by a specific score on a test called the MMSE.
  • If taking medication for Alzheimer's Disease (except certain types), the dose must have been stable for at least 12 weeks before starting the study.
  • If taking over-the-counter supplements for memory, like gingko biloba or omega-3, the dose must not exceed the recommended amount for at least 12 weeks before starting the study.
  • Participants must be able to visit the study center and complete various tests.
  • Participants must have a caregiver who can attend all study visits, help with study procedures, and provide information about the participant's behavior and safety. The caregiver should spend enough time with the participant to notice changes and must be able to understand and speak the language used at the study center.
  • Male participants must agree to use a reliable method of birth control during the study and for 3 months after the last dose, and must not donate sperm during this time.
  • Female participants must not be pregnant or breastfeeding. If they can have children, they must use a reliable method of birth control during the study and for 3 months after the last dose, and have negative pregnancy tests before starting the study.
  • Participants must provide written consent to join the study, either themselves or through a legal representative, along with their caregiver.

Who cannot join the trial?

4 criteria

  • Individuals who do not have a diagnosis of Alzheimer's Disease cannot participate. Alzheimer's Disease is a condition that affects memory and thinking skills.
  • Participants must be within a specific age range, typically adults and older adults.
  • Both males and females are eligible, but certain health conditions may exclude participation.
  • Individuals who are considered part of a vulnerable population may not be eligible. Vulnerable populations include groups that may have additional risks or require special protection.
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Investigated drugs

GV1001 is a medication being studied for its potential to help people with mild to moderate Alzheimer's Disease. It is given as an injection under the skin. The main goal of the study is to see if GV1001 can improve thinking and memory skills in people with Alzheimer's. The study also aims to ensure that GV1001 is safe for the participants to use.

What is already known about the treatment

GV1001 – This medication is administered subcutaneously, meaning it is injected under the skin. It is currently being studied in a Phase 2 clinical trial for its potential use in treating mild to moderate Alzheimer's Disease. The main therapeutic indication for GV1001 is to improve cognitive function in individuals with Alzheimer's. At the molecular level, GV1001 is believed to work by modulating immune responses and reducing inflammation, which may help protect brain cells. It is classified pharmacologically as a peptide-based therapeutic agent.

Investigated diseases

Alzheimer's Disease – Alzheimer's Disease is a progressive neurological disorder that leads to memory loss and cognitive decline. It primarily affects older adults and is characterized by the gradual deterioration of brain cells. Symptoms often begin with mild memory lapses and confusion, eventually progressing to more severe memory impairment, disorientation, and difficulty with language and reasoning. As the disease advances, individuals may experience changes in behavior and personality, and they may require assistance with daily activities. The progression of Alzheimer's Disease varies among individuals, but it typically worsens over time, affecting the ability to perform everyday tasks.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-511610-20-00Protocol codeGV1001-AD-CL2-007Estimated enrolment180 patientsSponsorGemvax & Kael Co. Ltd.

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