BridgeMD
A Phase 2b Clinical Study of the P38 Alpha Kinase Inhibitor Neflamapimod in Patients with Dementia with Lewy Bodies (DLB)
EU CTIS ID: 2023-504373-20-00
What this study is testing
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).
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- Diagnosis of any other ongoing central nervous system (CNS) condition other than DLB).
- History of previous neurosurgery to the brain within the past five years.
- 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.
- Plasma ptau181 result above the threshold that indicates evidence of pathology associated with Alzheimer’s disease at Screening.
- 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.
See the full eligibility criteria
- 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.
- Diagnosis of any other ongoing central nervous system (CNS) condition other than DLB).
- History of previous neurosurgery to the brain within the past five years.
- 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.
- Plasma ptau181 result above the threshold that indicates evidence of pathology associated with Alzheimer’s disease at Screening.
- 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.
- Poorly controlled clinically significant medical illness or other disease that would interfere with assessment of drug safety.
- 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.
- Known human immunodeficiency virus, hepatitis B, or active hepatitis C virus infection.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.