Not recruiting

Study on Neflamapimod for Patients with Dementia with Lewy Bodies

Verified siteInvestigationalNo 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). This is a type of progressive dementia that leads to a decline in thinking, reasoning, and independent function due to abnormal microscopic deposits that damage brain cells over time. The treatment being tested in this study is a medication called Neflamapimod, which is taken as a capsule by mouth. Neflamapimod is also known by its code name VX-745 and is designed to inhibit a specific enzyme in the brain that may be involved in the progression of DLB.

The purpose of this study is to evaluate the safety and tolerability of Neflamapimod in patients with DLB. Participants in the study will take 80 mg of Neflamapimod twice daily for a period of 24 weeks. Throughout the study, researchers will monitor how the body processes the medication and any effects it may have on the participants' health and cognitive abilities. The study will also assess changes in various cognitive and behavioral measures, such as memory, daily living activities, and any fluctuations in cognitive function.

Participants will undergo several assessments, including tests that measure executive functioning, daily living activities, and cognitive fluctuations. These assessments will help determine any changes from the start of the study to the end of the 24-week period. Additionally, the study will look at changes in brain structure using MRI scans. The overall goal is to gather information that could lead to better understanding and treatment of DLB.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, cognitive abilities, and medical history related to dementia with Lewy bodies.
Participants must have normal or corrected vision and hearing, and no history of learning difficulties that could affect cognitive testing.
Step 2
Medication administration
Participants receive neflamapimod, a medication in capsule form, taken orally.
The dosage is 80 mg, administered twice daily for a duration of 24 weeks.
Step 3
Monitoring and assessments
Throughout the 24-week period, regular monitoring is conducted to evaluate the safety and tolerability of the medication.
Assessments include cognitive and functional tests, such as the Montreal Cognitive Assessment (MOCA) and the Clinical Dementia Rating Sum of Boxes (CDR-SB).
Step 4
Final evaluation
At the end of the 24-week period, a final evaluation is performed to assess changes in cognitive and behavioral measures.
This includes reviewing changes in test scores and any side effects experienced during the trial.

Who can join the trial?

9 criteria

Men and women aged 55 years or older.
The person must be willing and able to provide written informed consent, which means they agree to participate in the study after understanding what it involves.
The person must have a probable diagnosis of Dementia with Lewy Bodies (DLB) according to specific guidelines.
The person must have a MoCA score of 18 or higher during the screening. MoCA is a test that checks memory and thinking skills.
If the person is taking medications called cholinesterase inhibitors or memantine for memory and thinking, they must have been on these medications for more than 3 months and on a stable dose for at least 6 weeks before starting the study. If they are not currently taking these medications but have taken them before, they must have stopped at least 3 months before starting the study.
The person must have normal or corrected eyesight and hearing to be able to complete all parts of the study tests.
The person should not have a history of learning difficulties that could affect their ability to complete the study tests.
The person must have received a COVID-19 vaccination unless there is a medical reason they cannot be vaccinated, or they have had a natural infection.
The person must have a reliable informant or caregiver who can provide information about them.

Who cannot join the trial?

4 criteria

Patients who do not have a diagnosis of Dementia with Lewy Bodies (DLB) cannot participate. DLB is a type of brain disorder that affects memory and thinking.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.
Patients who do not meet other specific health criteria set by the study cannot participate. These criteria ensure the safety and appropriateness of the study for each participant.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Hopital Beaujon
Verified
Clichy, France
Hôpitaux Universitaires Strasbourg - Hôpital de Hautepierre
Verified
STRASBOURG, Alsace, France

Trial locations

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Investigated drugs

Neflamapimod is a medication being studied for its potential to help patients with dementia with Lewy bodies. It works by inhibiting a specific enzyme called P38 alpha kinase, which is thought to play a role in the disease process. The study aims to evaluate how safe and tolerable this medication is for patients, as well as how the body processes it.

Neflamapimod

What is already known about the treatment

Neflamapimod – Neflamapimod is administered orally in the form of tablets, taken twice daily. It is currently being studied in a Phase 2a clinical trial for its potential use in treating Dementia with Lewy Bodies (DLB). The medication works by inhibiting the enzyme P38 alpha kinase, which is believed to play a role in inflammation and neuronal damage associated with DLB. Neflamapimod is classified as a kinase inhibitor, and its development is focused on improving cognitive function and reducing symptoms in patients with this type of dementia.

Investigated diseases

Dementia with Lewy Bodies – Dementia with Lewy Bodies is a progressive brain disorder characterized by the presence of abnormal protein deposits called Lewy bodies in the brain. These deposits affect chemicals in the brain, leading to problems with thinking, movement, behavior, and mood. People with this condition often experience visual hallucinations and changes in alertness and attention. Movement symptoms similar to those seen in Parkinson's disease, such as tremors and stiffness, may also occur. Cognitive fluctuations, where a person's abilities can change from day to day, are common. Over time, symptoms tend to worsen, affecting daily activities and quality of life.