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Study on Neflamapimod for Treating Dementia with Lewy Bodies in Patients Aged 55 and Older

Registered drugNo placebo
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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 a condition known as Dementia with Lewy Bodies (DLB). DLB is a type of progressive dementia that leads to a decline in thinking, reasoning, and independent function. The study will use a medication called Neflamapimod, which is taken as a capsule by mouth. Neflamapimod is being tested to see if it can help improve symptoms in people with DLB.

The purpose of the study is to evaluate the effectiveness of Neflamapimod compared to a placebo. Participants in the study will be randomly assigned to receive either Neflamapimod or a placebo. The study will last for several weeks, during which participants will take the medication and attend regular check-ups. These check-ups will help researchers monitor the participants' health and any changes in their condition.

In addition to taking the medication, participants will undergo a special imaging test called a DaTSCAN. This test helps to confirm the diagnosis of DLB by showing changes in the brain. The study aims to see if Neflamapimod can improve scores on a scale that measures dementia symptoms, as well as other tests that assess movement and cognitive abilities. The results of this study will help determine if Neflamapimod is a beneficial treatment for people with DLB.

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

    Initial visit

    Upon joining the study, an initial visit is scheduled. During this visit, eligibility is confirmed based on specific criteria, such as age and medical history.

    A DaTscan may be performed to confirm the diagnosis of dementia with Lewy bodies. If a DaTscan is not possible, a history of certain sleep disorders may also qualify.

  2. Step 2

    Baseline assessments

    Baseline assessments are conducted to evaluate cognitive and functional abilities. These assessments include tests that measure attention, executive function, and visual learning.

    The Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) is used to assess the severity of dementia symptoms.

  3. Step 3

    Medication administration

    Participants are randomly assigned to receive either the study medication, neflamapimod, or a placebo. The medication is provided in capsule form for oral use.

    The dosage is 40 mg, taken twice daily for a duration of 16 weeks.

  4. Step 4

    Follow-up visits

    Regular follow-up visits are scheduled throughout the 16-week period. These visits are used to monitor health, assess any side effects, and ensure adherence to the medication regimen.

    Additional cognitive and functional assessments are conducted to track changes over time.

  5. Step 5

    Final assessment

    At the end of the 16-week period, a final assessment is conducted. This includes repeating the baseline assessments to evaluate any changes in cognitive and functional abilities.

    The results are compared between those who received neflamapimod and those who received the placebo to determine the effectiveness of the treatment.

Who can join the trial?

9 criteria

  • Men and women aged 55 years or older.
  • Willing and able to provide written consent to participate in the study.
  • Have a diagnosis of probable Dementia with Lewy Bodies (DLB) based on specific criteria, which includes a positive DaTscan™ (a type of brain scan). If the DaTscan is negative, a history of REM sleep behavioral disorder (RBD) confirmed by a sleep study can also qualify.
  • Have a CDR Global Score (a measure of dementia severity) of less than 2.0 at the time of screening.
  • If currently taking cholinesterase inhibitor therapy (a type of medication for dementia), must have been on this treatment for more than 3 months and on a stable dose for at least 6 weeks before starting the study. If not taking this medication, it must have been stopped at least 3 months before starting the study.
  • Have normal or corrected vision and hearing abilities to complete all parts of the cognitive and functional tests.
  • No history of learning difficulties that could affect the ability to complete cognitive tests.
  • Must have received a SARS-CoV-19 vaccination unless there is a medical reason not to be vaccinated or have a history of natural infection.
  • Must have a reliable informant or caregiver who can provide information about the participant's condition.

Who cannot join the trial?

5 criteria

  • Patients who are not at least 55 years old.
  • Patients who do not have a diagnosis of probable **Dementia with Lewy Bodies (DLB)**. This is a type of dementia that affects thinking, movement, behavior, and mood.
  • Patients who do not have a positive **DaTscan™**. This is a type of brain scan that helps doctors see how well certain areas of the brain are working.
  • Patients who do not have a **CDR Global Score** of 0.5 or 1.0. This score is used to measure the severity of dementia symptoms.
  • Patients who do not have a history of **REM sleep behavioral disorder (RBD)** verified by **polysomnography (PSG)**. RBD is a sleep disorder where people act out their dreams, and PSG is a test that records brain waves and other body functions during sleep.
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Investigated drugs

Neflamapimod is a medication being studied for its potential to help people with a type of dementia called Dementia with Lewy Bodies (DLB). This medication works by blocking a specific protein in the brain that is thought to be involved in the development of DLB. The goal of using neflamapimod in this study is to see if it can improve symptoms of dementia, such as memory and thinking problems, by slowing down or stopping the damage to brain cells. Participants in the trial will take neflamapimod to see if it can help improve their condition compared to those who do not receive the medication.

What is already known about the treatment

Neflamapimod – Neflamapimod is administered orally and is currently being studied in a Phase 2b clinical trial for its potential use in treating Dementia with Lewy Bodies (DLB), a condition affecting individuals aged 55 and older. The medication works by inhibiting a specific enzyme called P38 Alpha Kinase, which is believed to play a role in the inflammation processes associated with neurodegenerative diseases. Neflamapimod is classified as a kinase inhibitor and aims to improve cognitive function in patients with DLB, as measured by the Clinical Dementia Rating Scale.

Investigated diseases

Dementia with Lewy Bodies – Dementia with Lewy Bodies is a progressive neurological disorder characterized by the presence of abnormal protein deposits called Lewy bodies in the brain. These deposits affect brain regions involved in thinking, memory, and movement. The disease often begins with cognitive decline, including difficulties with attention, executive function, and visual perception. As it progresses, individuals may experience fluctuations in alertness and attention, visual hallucinations, and motor symptoms similar to Parkinson's disease, such as tremors and stiffness. Sleep disturbances, particularly REM sleep behavior disorder, are also common. Over time, these symptoms can become more pronounced, impacting daily activities and quality of life.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-504373-20-00Protocol codeEIP21-NFD-504Estimated enrolment160 patientsSponsorEip Pharma Inc.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).