Clinical Study of Neflamapimod in Patients With Primary Progressive Aphasia
This study is investigating a new medication, neflamapimod, for people living with a specific type of dementia called nonfluent variant primary progressive aphasia (nfvPPA). This condition mainly affects a person's ability to speak and understand language. The main aims of this study are to understand if neflamapimod is safe, how the body handles it, and if it could help with the symptoms of nfvPPA. Participants will receive either the study drug or a placebo (a dummy pill). This is a Phase 2 study, which means it’s an early stage where researchers are exploring its potential effects before larger studies can be done.
At a glance
What is this study about?
This research study is focused on a condition called nonfluent variant primary progressive aphasia, often shortened to nfvPPA. This is a very specific type of dementia that primarily affects a person's language skills, making it difficult for them to speak fluently or form proper sentences. This study is exploring a new drug, neflamapimod, to see if it could be a helpful treatment for people with nfvPPA. At the moment, there aren't many treatments specifically for this condition, so finding new options is really important.
The main goals of this study are to make sure the drug is safe to use and to understand how the body processes it. Researchers will also be looking closely to see if neflamapimod has any positive effects on the language and thinking abilities of people with nfvPPA. Because this is an 'exploratory' study, it means we are in the early stages of learning about this drug's potential.
Participants will be randomly assigned to receive either neflamapimod or a placebo, which looks like the real drug but contains no active medicine. This is a common way to test new treatments fairly. By comparing the results from both groups, researchers can get a clearer picture of whether the drug is truly making a difference.
Key takeaways
- This study investigates a new drug for a specific language-focused dementia called nfvPPA.
- It aims to check the safety and potential benefits of the drug, neflamapimod.
- Participants will receive either the active drug or a placebo.
- A dedicated study partner is required for all appointments.
- The study involves regular visits for health checks and memory/language tests.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
To join this study, you would need to be between 40 and 85 years old. You must have received a diagnosis of nonfluent variant primary progressive aphasia (nfvPPA) from a doctor. This diagnosis typically means you have difficulties with forming sentences or speaking clearly, and that your understanding of simple words is generally good, but complex sentences might be harder to grasp. You’ll also need to have vision and hearing that’s good enough to complete various tests in the study, and be able to speak English well.
It’s also important that you have a reliable study partner, such as a family member or close friend, who can come with you to all your study appointments. This partner must also be able to read, write, and understand English.
However, some things would mean you couldn't take part. For example, if MRI brain scans show something different from nfvPPA, or if you have other brain conditions like Alzheimer's disease, dementia with Lewy bodies, or Parkinson's disease that are more prominent than your language problems, you likely wouldn't be eligible. Also, if movement problems are severe enough to affect your ability to do the study tests, you might not be able to participate.
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.
- Are you between 40 and 85 years old?
- Have you been diagnosed with nonfluent variant primary progressive aphasia (nfvPPA)?
- Do you have a study partner who can attend appointments with you and speaks English?
- Are you able to see and hear well enough for study tests?
- Is your primary brain condition nfvPPA (i.e., no other major brain conditions)?
- Are you comfortable speaking and understanding English?
What does participation involve?
If you decide to take part in this study, you would be given either the study drug, neflamapimod, or a placebo (a dummy pill) for a period. You wouldn't know which one you are receiving. You would need to attend several appointments with the study team, and these visits would include various assessments. These might involve tests of your language and thinking abilities, physical check-ups, and possibly blood tests or brain scans.
Your study partner would need to come with you to all these visits to help with information or observations. The exact number of visits and the total length of time you'd be involved in the study would be explained to you fully before you agree to participate. You would also have regular contact with the study team throughout your involvement.
Potential risks and benefits
Locations (7)
- Northwestern Memorial HospitalVerified postcodeChicago, United States· Active not recruiting
- Mayo ClinicVerified postcodeRochester, United States· Active not recruiting
- Columbia UniversityVerified postcodeNew York, United States· Active not recruiting
- The Ohio State UniversityVerified postcodeColumbus, United States· Active not recruiting
- Hospital of the University of PennsylvaniaVerified postcodePhiladelphia, United States· Active not recruiting
- Windsor Research Unit, Fulbourn HospitalVerified postcodeCambridge, United Kingdom· Recruiting
- Clinical Ageing Research Unit, Campus for Ageing and Vitality, Biomedical Research BuildingVerified postcodeNewcastle upon Tyne, United Kingdom· Recruiting
Common questions
What is nfvPPA?
NfvPPA is a rare form of dementia that mainly affects a person's ability to speak properly and understand complex sentences.
What is neflamapimod?
Neflamapimod is the new experimental drug being tested in this study to see if it can help with nfvPPA symptoms.
What is a placebo?
A placebo is a 'dummy pill' that looks exactly like the study drug but doesn't contain any active medicine. It helps researchers fairly compare the effects of the real drug.
Will I know if I'm getting the drug or the placebo?
No, neither you nor the study doctors will know if you are receiving the active drug or the placebo until after the study is complete. This is to ensure fair results.
Do I need a study partner?
Yes, you must have a reliable study partner who can attend all appointments with you and can communicate well in English.
How to find out more
Amanda Gardner
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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