An open-label Phase 2a clinical study of the P38 alpha kinase inhibitor neflamapimod in patients with dementia with Lewy Bodies
This study is an open-label extension study.
Information about the drug that will be tested in the study
Administration
Capsule twice daily with the morning and evening meals
Is the drug already on the market for another medical condition?
No
Will all participants receive the same drug?
All participants will receive capsules of neflamapimod.
Information about participating in the trial.
What are the researchers trying to find out?
The purpose of the study is to assess the safety and tolerability of neflamapimod for people in the early stages of dementia with Lewy bodies.
How long will the treatment last?
- 24 weeks
What your involvement will entail?
- During the study, participants will be asked to complete tests that will assess their cognition, function, behaviour, daily living activities and hallucinations symptoms (i.e. CDR-SB, MoCA, ADCS- ADL, DCFS, MBI-C, PDAP)
- To undergo brain scans (MRI).
Further information on the procedures, tests and number of visits can be obtained from the study team.
Who can participate in this study?
Who can participate in the study?
To take part in the study, participants must:
- Be aged >55 years old
- Have a diagnosis of probable dementia with Lewy Bodies, according to the McKeith criteria
- Have a score above 18 on the MoCA test
- If the person is taking approved symptomatic medication for dementia (i.e. donepezil, rivastigmine, galantamine or memantine) the dosing regimen must have been stable for at least 6 weeks. If the person received such therapy previously, that therapy must have been discontinued at least 3 months prior to the start of the treatment.
- Have a study partner who has regular contact with the participant is willing to participate in study procedures throughout the study duration.
Who cannot participate in the study?
People cannot take part in the study if they have or have experienced:
- Diagnosis of any other ongoing central nervous system condition other than dementia with Lewy Bodies (e.g., post-stroke dementia, vascular dementia, Alzheimer’s disease, Frontotemporal dementia or Parkinson’s disease)
- Pregnancy or unable to adhere to contraception methods
- Any disease or condition that could, in the opinion of the investigator, interfere with the safety, tolerability and/or study assessments (e.g., psychiatric disorder, hypertension, significant cardiovascular, pulmonary, renal, liver, infectious disease, immune disorder)
- Any alcohol or drug abuse or dependence within the past 2 years
- Known tuberculosis, positive HIV test or Active hepatitis B and/or C
- Participated in a study of an investigational drug less than 6 weeks before enrolment in this study
- History of previous neurosurgery to the brain within the past five years.
The above list is not exhaustive. It includes the most common conditions and diseases that might exclude people from the study.
Information for your doctor
Eu CT Number
2024-511446-39-00
Study contact information
Link to full text
https://euclinicaltrials.eu/ctis-public/view/2024-511446-39-00
The information contained in this document is based on information available on public registries (e.g. clinicaltrials.gov website) in January 2025.
This document has been reviewed by a member of the European Dementia Carers Working Group.
