A Study to Assess Safety and Tolerability and to Explore Efficacy of NSC001 in Mild to Moderate Alzheimer's Disease
This study is exploring a new medicine called NSC001 for individuals living with mild to moderate Alzheimer's disease. The main goals are to check if the medicine is safe and well-tolerated, meaning it doesn't cause too many side effects. Researchers also want to see if NSC001 might help improve how people think and remember things. Half the participants will receive NSC001, and the other half will receive a dummy pill (placebo) to fairly compare the effects. This is a very early stage of research, aiming to gather important information before wider use is considered. It's hoped this research could lead to new ways to help manage Alzheimer's symptoms.
At a glance
What is this study about?
This research study is focused on a new medicine called NSC001, which is being tested for people with mild to moderate Alzheimer's disease. Alzheimer's is a condition that affects memory, thinking, and behaviour. The main aims of this study are to find out if NSC001 is safe for people to take and how well their bodies handle it. Researchers will be looking carefully for any side effects.
Alongside safety, the study also wants to see if NSC001 can help improve memory and other mental abilities in people with Alzheimer's. This medicine is designed to work on specific parts of the brain that are involved in thinking and learning. By understanding how NSC001 affects these areas, doctors hope to find new ways to help manage the symptoms of Alzheimer's.
This study involves two groups: one will receive the actual medicine (NSC001), and the other will get a dummy pill (placebo). This is a standard way to test new treatments fairly, as it helps researchers see if any changes are truly due to the medicine or other factors. The information gathered from this study, even at this early stage, is very important for deciding if NSC001 could be a helpful treatment in the future.
Key takeaways
- This study is testing a new medicine (NSC001) for mild to moderate Alzheimer's.
- It aims to check the medicine's safety and whether it improves memory and thinking.
- A 'study partner' (trusted friend/family) is required to help you during participation.
- You might receive the new medicine or a dummy pill (placebo).
- Participation involves regular clinic visits for check-ups and tests.
- You can stop participating at any time without affecting your NHS care.
Who may be eligible?
To join this study, you generally need to be between 50 and 85 years old and have been diagnosed with mild to moderate Alzheimer's disease. It's important that an independent doctor, not connected to the study, confirms you understand what taking part involves.
You'll also need a trusted friend or family member, called a 'study partner' or 'caregiver', who can help you with your pills, come to appointments, and share information about how you're doing. This person needs to spend at least 10 hours a week with you. Researchers will check information like brain scans or special blood tests that support your Alzheimer's diagnosis.
For women, you need to have gone through menopause for at least two years or have had certain surgeries that prevent pregnancy. Men with partners who could become pregnant must agree to use effective contraception during the study and for six months afterwards.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Am I between 50 and 85 years old?
- Do I have a diagnosis of mild to moderate Alzheimer's disease?
- Do I have a trusted friend or family member who can be my study partner and help me?
- For women, have I been through menopause for at least two years or had relevant surgery?
- Am I willing and able to attend all study visits and take the medication as instructed?
What does participation involve?
If you decide to take part, you'll be assigned to either receive the new medicine (NSC001) or a dummy pill (placebo). Neither you nor the study team will know which you are receiving. You'll take the study medication by mouth regularly, as instructed. Your study partner will play a vital role, helping you remember to take your medication and attending appointments with you.
Taking part will involve a number of visits to the study clinic for assessments. These will include check-ups, memory and thinking tests, and possibly blood samples. The full duration of your participation in the study, including all visits and follow-up, will be explained to you by the study team. You will have a chance to ask any questions you have about the schedule and what's involved.
Potential risks and benefits
Locations (10)
- Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft GmbHVerified postcodeSalzburg, Austria· Recruiting
- University Hospital GrazVerified postcodeGraz, Austria· Recruiting
- Medical University InnsbruckVerified postcodeInnsbruck, Austria· Recruiting
- Medical University ViennaVerified postcodeVienna, Austria· Recruiting
- Clinic Altenburger Land GmbHVerified postcodeAltenburg, Germany· Not yet recruiting
- Zentrum fuer klinische Forschung Dr. I. Schoell GmbHVerified postcodeBad Homburg, Germany· Recruiting
- University Clinic KölnVerified postcodeCologne, Germany· Recruiting
- Universitaetsmedizin GoettingenVerified postcodeGöttingen, Germany· Recruiting
- Dynamikos GmbH Institut fuer Studien zur Psychischen GesundheitVerified postcodeMannheim, Germany· Recruiting
- SANOS ClinicVerified postcodeRatingen, Germany· Recruiting
Common questions
What is NSC001?
NSC001 is a new experimental medication being tested to see if it can help improve memory and thinking in people with mild to moderate Alzheimer's disease.
What is a 'placebo'?
A placebo is a dummy pill that looks like the real medication but contains no active medicine. It's used to compare against the new medicine fairly.
Who can be my 'study partner'?
Your study partner needs to be a trusted friend or family member who spends at least 10 hours a week with you and can help you with the study requirements.
Will I know if I'm getting the real medicine?
No, during the study, neither you nor the study team will know if you are receiving NSC001 or the placebo. This helps ensure the study results are fair.
How long does the study last?
The team running the study will tell you the exact duration, including how many visits are needed and any follow-up, during the initial discussions.
How to find out more
Barbara Fridrich, DI
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.