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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Brain Research Center Den Bosch B.V.	s-Hertogenbosch	The Netherlands
Brain Research Center Amsterdam B.V.	Amsterdam	The Netherlands
Brain Research Center Zwolle B.V.	Zwolle	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Not recruiting	15.07.2023

Trial locations

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.

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 ID:

2023-504373-20-00

Protocol code:

EIP21-NFD-504

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?