Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase 2b Clinical Study of the P38 Alpha Kinase Inhibitor Neflamapimod in Patients with Dementia with Lewy Bodies (DLB)

This study is investigating a new medicine called neflamapimod for people who have Dementia with Lewy Bodies (DLB). DLB affects memory, thinking, and movement. The main goal is to find out if neflamapimod can help improve these symptoms over a 16-week period, compared to a placebo (a dummy pill). Researchers will measure changes in memory and daily activities to see if the medicine is effective. It's a Phase 2b study, meaning it's exploring whether the treatment works and is safe. Participants will be aged 55 or over and diagnosed with probable DLB, often confirmed by a special brain scan.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Eip Pharma Inc.

Enrolment target

Start

24 Jul 2023

What is this study about?

This research study is about a new drug called neflamapimod, which is being tested for people who have Dementia with Lewy Bodies, often shortened to DLB. DLB is a type of dementia that can affect memory, thinking, and movement in various ways, and can also cause vivid dreams where you act them out while sleeping.

The main aim of this study is to see if taking neflamapimod can help improve some of these symptoms over 16 weeks. They will be comparing how people taking the new drug do against people taking a 'placebo' – which looks exactly like the study drug but contains no active medicine. This helps researchers work out if any changes are truly due to the new medicine or something else.

Researchers will use special tests to check for changes in memory, thinking, and how well people manage daily tasks. They'll also look at things like walking speed and balance. By understanding how neflamapimod affects these areas, doctors hope to learn if it could become a helpful treatment for people with DLB in the future.

Key takeaways

The study tests a new medicine (neflamapimod) for Dementia with Lewy Bodies (DLB).
It aims to see if the medicine improves memory and thinking over 16 weeks.
Participants will receive either the active medicine or a placebo (dummy pill).
Eligibility requires a diagnosis of probable DLB and specific age/test results.
Regular clinic visits and assessments will be part of taking part.
This is a Phase 2b study, meaning it's still in the early stages of research.

Who may be eligible?

To join this study, you need to be aged 55 or older. You must have received a diagnosis of probable Dementia with Lewy Bodies (DLB) based on specific features that doctors look for. One key way this is confirmed is through a special brain scan called a DaTscan, which helps to identify changes in the brain linked to DLB. Your doctor will know if your DaTscan results meet the study requirements.

If you haven't had a DaTscan, but you have a history of a sleep condition called REM sleep behaviour disorder, confirmed by a sleep study, you might still be able to take part if you also have other signs of DLB. Your doctor will need to check all your medical records to see if you fit these specific criteria.

Additionally, your current level of memory and thinking difficulties will be assessed using a common scale called CDR Global Score, and you would need to score 0.5 or 1.0 on this scale. Your doctor will be able to explain what this means for you.

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 55 years old or older?
Have you been diagnosed with probable Dementia with Lewy Bodies (DLB)?
Have you had a positive DaTscan brain scan, or a confirmed REM sleep behaviour disorder with other DLB signs?
Do you have a CDR Global Score of 0.5 or 1.0 (your doctor can check this)?
Are you able to attend regular clinic visits and take daily medication for 16 weeks?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given either the study medicine (neflamapimod) or a placebo, which looks identical but contains no active drug. You won't know which one you're taking, nor will your study doctor, until the very end. The medicine will come as reddish-orange hard capsules which you'll need to take regularly for 16 weeks.

Throughout these 16 weeks, you will have several visits to the study clinic. During these visits, the study team will carry out various assessments. These will include tests to check your memory, thinking, and daily activities, as well as timing how long it takes you to do certain movements, like walking. They will also assess your overall condition and general health. You will also have follow-up appointments after the 16 weeks of treatment to check on your progress. The total duration of your involvement, including follow-up, will be explained by the study team.

Potential risks and benefits

Taking part in any study has possible benefits and risks. You might benefit from closer medical attention and potentially from the new medicine if it proves effective. However, the medicine may not help you, or you might experience side effects. The study drug is given in capsules, and some people might have reactions to these. The placebo capsules contain common ingredients like lactose, which some people may be sensitive to. Your doctor will discuss all known potential risks and side effects with you in detail. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Netherlands

Common questions

What is Dementia with Lewy Bodies (DLB)?

DLB is a type of memory problem and thinking difficulty that can also affect movement, sleep, and cause hallucinations. It's different from Alzheimer's disease.

What is a placebo?

A placebo is a 'dummy' pill that looks exactly like the study medicine but doesn't contain any active drug. It helps researchers see if the real medicine is truly working.

What does 'Phase 2b' mean for a study?

Phase 2b means this is an early-stage study exploring if the medicine works and is safe. It's not yet approved for general use.

Will I know if I'm getting the real medicine or the placebo?

No, neither you nor your study doctor will know whether you are taking neflamapimod or the placebo until the study is over. This is called 'blinding' and helps ensure fair results.

What is a DaTscan?

A DaTscan is a special brain scan that helps doctors diagnose conditions like DLB by looking at certain chemical pathways in the brain.