A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Design, Prospective, 52-Week, Phase 2 Clinical Study to Evaluate the Safety and Efficacy of GV1001 Administered Subcutaneously for the Treatment of Mild to Moderate Alzheimer's Disease
This research study is looking at a new treatment called GV1001 for people living with mild to moderate Alzheimer's disease. For 52 weeks, we want to find out if this medicine, given as an injection under the skin, is safe to use and if it can help with memory and thinking problems. Participants will either receive the active medicine or a 'dummy' injection that looks the same but contains no medicine, to fairly compare the effects. Throughout the study, we will regularly check on participants' health, how their memory and thinking are doing, and any side effects they might experience. This helps us understand if GV1001 could be a helpful future treatment.
At a glance
What is this study about?
This clinical trial is designed to investigate a new potential treatment for Alzheimer's disease, called GV1001. Alzheimer's disease is a condition that affects memory, thinking, and behaviour. Currently, there isn't a cure, but researchers are working hard to find new ways to manage the condition and improve quality of life. This particular study focuses on people who have mild to moderate forms of the disease.
The main aim of this study is to see if GV1001 is safe when given as an injection under the skin. We also want to understand if it can help slow down or improve some of the changes in memory and thinking that happen with Alzheimer's over a period of 52 weeks (about one year). Researchers will be carefully monitoring participants for any changes in their symptoms and overall health.
To make sure the study is fair and accurate, some participants will receive the actual medicine, GV1001, while others will receive a 'placebo.' A placebo is an injection that looks exactly like the study medicine but doesn't contain any active drug. This helps us compare the effects of GV1001 against what would happen without the active treatment. Neither the participants nor their doctors will know who is receiving which, until the end of the study. This helps ensure that everyone's observations are as unbiased as possible.
Key takeaways
- This study is testing a new medicine, GV1001, for mild to moderate Alzheimer's disease.
- It aims to check if GV1001 is safe and helps with memory and thinking.
- The study lasts for 52 weeks (about one year) and involves regular clinic visits.
- Some participants will get the actual medicine, others a dummy injection, without knowing which one.
- Both men and women aged 18 and over with mild to moderate Alzheimer's are welcome.
- You can stop participating at any time if you change your mind.
Who may be eligible?
To take part in this study, you need to be an adult aged 18 years or older. The study is open to both men and women.
Crucially, you must have been diagnosed with mild to moderate Alzheimer's disease to be considered for this trial. The research team will have specific medical criteria to decide if the study is suitable for you.
There may be other specific health requirements or conditions that mean someone cannot join the study, even if they meet the age and diagnosis criteria. These will be discussed in detail by the study team to ensure everyone's safety and that the study can collect accurate information.
- Are you 18 years old or older?
- Have you been diagnosed with mild to moderate Alzheimer's disease?
- Are you able to attend regular clinic appointments for about one year?
- Are you willing to receive injections under your skin?
- Are you comfortable with undergoing various medical tests, like blood tests and ECGs?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you'll be involved for about one year. Participants will receive regular injections of either the study medicine (GV1001) or a dummy injection. These injections are given under the skin. You will have regular visits to the clinic where the study team will carry out various checks.
These checks will include assessments of your memory and thinking, blood and urine tests, heart trace (ECG) measurements, and checks of your blood pressure, pulse, breathing, and temperature. You'll also be asked questions about your mood, including any thoughts or feelings of sadness or self-harm, using a special questionnaire. All these assessments help the researchers understand how the medicine is affecting your health and whether it's making a difference. After your last dose of the study medicine, there will usually be a follow-up visit to ensure everything is okay.
Potential risks and benefits
Locations (7)
- —Italy
- —Portugal
- —Poland
- —France
- —Spain
- —Finland
- —Netherlands
Common questions
What is Alzheimer's disease?
Alzheimer's disease is a brain condition that gradually affects memory, thinking, and daily activities.
What is GV1001?
GV1001 is a new medicine being tested to see if it can help people with mild to moderate Alzheimer's disease.
Will I know if I'm getting the real medicine or a dummy injection?
No, neither you nor your doctor will know if you're receiving the active medicine or the dummy injection until the study ends. This helps keep the results fair.
How long will the study last?
The main part of the study will last for 52 weeks, which is about one year.
What tests will I have during the study?
You will have memory and thinking tests, blood and urine checks, heart scans (ECGs), and regular checks of your vital signs like blood pressure.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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