A Phase 2b Clinical Study of the P38 Alpha Kinase Inhibitor Neflamapimod in Patients with Dementia with Lewy Bodies (DLB)
Key facts
- Where
- 's-Hertogenbosch, Amsterdam és Zwolle, HollandiaSee the 3 sites
- Phase
- 2. fázis
Where in Hollandia
- Brain Research Center Den Bosch B.V.'s-Hertogenbosch, HollandiaNo longer taking part
- Brain Research Center Amsterdam B.V.Amsterdam, HollandiaNo longer taking part
- Brain Research Center Zwolle B.V.Zwolle, HollandiaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Eip Pharma Inc.
- Trial code
- EU 2023-504373-20-00
- Record updated
- 2025. március 25.
- Original description
The primary objective is to demonstrate the efficacy of neflamapimod, compared to placebo, as a treatment for DLB, as assessed by the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB).Read full original descriptionShow less
The primary objective is to demonstrate the efficacy of neflamapimod, compared to placebo, as a treatment for DLB, as assessed by the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB).
Inclusion: Men and women aged ≥55 years; Subject is willing and able to provide written informed consent; Probable DLB by consensus criteria, including a positive DaTscan™. If the DaTscan is negative, but the subject has historical polysomnography (PSG)-verified REM sleep behavioral disorder (RBD), this will also qualify as probable DLB; CDR Global Score less than 2.0 at Screening; If the patient is currently receiving cholinesterase inhibitor therapy, the patient must have received such therapy for greater than 3 months and on a stable dose for at least 6 weeks at the time of randomization. If the patient is not currently receiving cholinesterase inhibitor therapy, that therapy must have been discontinued at least 3 months prior to randomization; Normal or corrected eyesight and auditory abilities, sufficient to perform all aspects of the cognitive and functional assessments; No history of learning difficulties that may interfere with their ability to complete the cognitive tests; Received vaccination for SARS-CoV-19 unless medical contraindications prevent being vaccinated or has a history of natural infection; Must have reliable informant or caregiver.
Exclusion: History of previous neurosurgery to the brain within the past five years; Suicidality, defined as active suicidal thoughts within 6 months before Screening or at Baseline or history of suicide attempt in previous 2 years, or, in the Investigator’s opinion, at serious risk of suicide; Ongoing major and active psychiatric disorder and/or other concurrent medical condition that, in the opinion of the Investigator, might compromise safety and/or compliance with study requirements; Diagnosis of alcohol or drug abuse within the previous 2 years; Participated in a study of an investigational drug less than six weeks or 5 half-lives of an investigational drug, whichever is longer, before enrollment in this study; Diagnosis of any other ongoing central nervous system (CNS) condition other than DLB); Plasma ptau181 result above the threshold that indicates evidence of pathology associated with Alzheimer’s disease at Screening; Poorly controlled clinically significant medical illness or other disease that would interfere with assessment of drug safety; Known human immunodeficiency virus, hepatitis B, or active hepatitis C virus infection; Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2 × the upper limit of normal (ULN), total bilirubin >1.5 × ULN, and/or International Normalized Ratio (INR) >1.5; Unwilling or unable to adhere to contraception requirements specified in the protocol; If female has a positive pregnancy test result during Screening and/or is unwilling or unable to adhere to the contraception requirements specified in the protocol.