RewinD-LB - Clinical Study of Neflamapimod in Patients With Dementia With Lewy Bodies
NCT ID: NCT05869669
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
159 participants
INTERVENTIONAL
2023-05-01
2025-06-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Neflamapimod
Neflamapimod will be administered with food for 16 weeks in subjects with DLB. Subjects will receive 3 capsules per day (TID) with food (i.e., with the morning, mid-day and evening meals).
Neflamapimod
Neflamapimod is a highly specific inhibitor of the intra-cellular enzyme mitogen-activated protein kinase14 (p38α) provided in 40mg capsules
Placebo
Placebo will be administered with food for 16 weeks in subjects with DLB. Subjects will receive 3 capsules per day (TID) with food (i.e., with the morning, mid-day and evening meals).
Placebo
Placebo is a capsule that looks just like neflamapimod but without the active ingredients
Interventions
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Neflamapimod
Neflamapimod is a highly specific inhibitor of the intra-cellular enzyme mitogen-activated protein kinase14 (p38α) provided in 40mg capsules
Placebo
Placebo is a capsule that looks just like neflamapimod but without the active ingredients
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subject or subject's legally authorized representative is willing and able to provide written informed consent.
3. 3\. Probable DLB by consensus criteria (McKeith et al, 2017), including a positive DaTscan™. Specifically, the subject must have the presence of dementia in association with:
* At least two (2) core clinical features (fluctuating cognition, visual hallucinations, REM sleep disorder, and/or parkinsonism); or
* One (1) core clinical feature plus an abnormal DaTscan™. Historical polysomnography (PSG)-verified REM sleep behavioral disorder (RBD), FDG-PET imaging, or MIBG myocardial scintigraphy can take the place of an abnormal DaTscan™ in a patient with only one core clinical feature.
4. CDR Global Score 0.5 (very mild dementia) or 1.0 (mild dementia) during Screening
5. Background dementia therapy:
* Not currently receiving cholinesterase inhibitor therapy. If the patient received such therapy previously, that therapy must have been discontinued at least 3 months prior to randomization.
* Receiving cholinesterase inhibitor therapy alone. 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. Except for reducing the dose for tolerability reasons, the dose of cholinesterase inhibitor may not be modified during the study.
* Memantine therapy is allowed, if it had been started at least 3 months prior to randomization and the patient is also receiving cholinesterase inhibitor therapy. If the patient has never been on cholinesterase inhibitor therapy (naïve), then memantine monotherapy is allowed.
6. Normal or corrected eyesight and auditory abilities, sufficient to perform all aspects of the cognitive and functional assessments.
7. No history of learning difficulties that may interfere with their ability to complete the cognitive tests.
8. Received vaccination for SARS-CoV-19 unless medical contraindications prevent being vaccinated, or has a history of natural infection.
9. Must have reliable informant or caregiver.
Exclusion Criteria
2. Plasma ptau181 result above the threshold that indicates evidence of pathology associated with Alzheimer's disease at Screening.
3. Suicidality, defined as active suicidal thoughts within 6 months before Screening or at Baseline, defined as answering yes to items 4 or 5 on the C-SSRS, or history of suicide attempt in previous 2 years, or, in the Investigator's opinion, at serious risk of suicide.
4. 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.
5. Diagnosis of alcohol or drug abuse within the previous 2 years.
6. Poorly controlled clinically significant medical illness, such as hypertension (blood pressure \>180 mmHg systolic or 100 mmHg diastolic); myocardial infarction within 6 months; uncompensated congestive heart failure or other significant cardiovascular, pulmonary, renal, liver, infectious disease, immune disorder, or metabolic/endocrine disorders or other disease that would interfere with assessment of drug safety.
7. 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. If patient is taking blood thinners (e.g., warfarin), and has no known liver issues, INR \>3.
8. Known human immunodeficiency virus, hepatitis B, or active hepatitis C virus infection.
9. 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.
10. History of previous neurosurgery to the brain within the past five years.
11. If male with female partner(s) of child-bearing potential, unwilling or unable to adhere to contraception requirements specified in the protocol.
12. If female who has not has not reached menopause \>1 year previously or has not had a hysterectomy or bilateral oophorectomy/salpingo-oophorectomy, has a positive pregnancy test result during Screening and/or is unwilling or unable to adhere to the contraception requirements specified in the protocol.
13. Weight less than 50kg.
All participants who complete the initial 16-week period of the study will be able to continue in the study and receive neflamapimod for an additional 32 weeks (8 months) regardless of whether they received neflamapimod of placebo during the the first 16 weeks.
55 Years
ALL
No
Sponsors
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National Institute on Aging (NIA)
NIH
Worldwide Clinical Trials
OTHER
CervoMed, Inc
UNKNOWN
EIP Pharma Inc
INDUSTRY
Responsible Party
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Locations
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Belfast Health & Social Care Trust
Belfast, , United Kingdom
South London and Maudsley NHS Foundation Trust
London, , United Kingdom
Re:Cognition Health
London, , United Kingdom
Cambridgeshire and Peterborough NHS Foundation Trust, Fulbourn Hospital - Windsor Research Unit
Cambridge, , United Kingdom
Barrow Neurological Institute
Phoenix, Arizona, United States
Banner Sun Health Research Institute
Sun City, Arizona, United States
Banner Alzheimer's Institute - Edson Family Lewy Body Dementia Center
Tucson, Arizona, United States
UCSD Health Sciences - Movement Disorders Center
La Jolla, California, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
Stanford Neuroscience Health Center
Palo Alto, California, United States
SC3 Research Group
Pasadena, California, United States
University of Colorado - Dept of Neurology
Aurora, Colorado, United States
Georgetown Univ Hospital - Dept of Neurology
Washington D.C., District of Columbia, United States
JEM Research Institute
Lake Worth, Florida, United States
ClinCloud
Melbourne, Florida, United States
AdventHealth Neuroscience Research
Orlando, Florida, United States
Panhandle Research and Medical Clinic
Pensacola, Florida, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Tandem Clinical Research
Marrero, Louisiana, United States
Johns Hopkins School of Medicine - Dept of Neurology
Baltimore, Maryland, United States
Mass General Hospital/Harvard Medical School - Dept of Neurology
Charlestown, Massachusetts, United States
Mayo Clinic - Alzheimer's Disease Research Center
Rochester, Minnesota, United States
University of Nebraska Medical Center - Dept of Neurological Sciences
Omaha, Nebraska, United States
Cleveland Clinic - Lou Ruvo Center for Brain Health
Las Vegas, Nevada, United States
Columbia University - Taub Institute/Neurology Dept
New York, New York, United States
University of North Carolina - Dept of Neurology
Chapel Hill, North Carolina, United States
NeuroScience Research Center
Canton, Ohio, United States
Cleveland Clinic - Center for Brain Health
Cleveland, Ohio, United States
Ohio State University - Dept of Neurology
Columbus, Ohio, United States
Center for Cognitive Health
Portland, Oregon, United States
Houston Methodist Hospital - Stanley Appel Neurology Dept
Houston, Texas, United States
Sana Research
Arlington, Virginia, United States
Virginia Commonwealth University - Parkinson's and Movement Disorders Center
Richmond, Virginia, United States
Brain Research Center - Den Bosch
's-Hertogenbosch, , Netherlands
Brain Research Center - Amsterdam
Amsterdam, , Netherlands
Brain Research Center - Zwolle
Zwolle, , Netherlands
University College London (UCL) Clinical Research Facility, University College London Hospitals NHS Foundation Trust
London, , United Kingdom
Campus Ageing Research Unit (CARU) - Newcastle upon Tyne, CNTW NHS Foundation Trust
Newcastle upon Tyne, , United Kingdom
Cornwall Partnership NHS Foundation Trust (University of Exeter)
Redruth, , United Kingdom
Memory Assessment and Research Centre (MARC) - Moorgreen Hospital
Southampton, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol: EIP21-NFD-504 Ex-US Protocol version
Document Type: Study Protocol: EIP21-NFD-504 US Protocol version
Document Type: Statistical Analysis Plan
Other Identifiers
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2023-504373-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
EIP21-NFD-504
Identifier Type: -
Identifier Source: org_study_id
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