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RewinD-LB - Clinical Study of Neflamapimod in Patients With Dementia With Lewy Bodies | Clinical Trials | Clareo Health

COMPLETEDPHASE2

RewinD-LB - Clinical Study of Neflamapimod in Patients With Dementia With Lewy Bodies

A Phase 2b Clinical Study of the P38 Alpha Kinase Inhibitor Neflamapimod in Patients With Dementia With Lewy Bodies

NCT05869669•EIP Pharma Inc

Summary

The purpose of this study is to determine whether neflamapimod can improve learning skills, problem solving skills, and memory loss in people diagnosed with DLB. More specifically, improvement in verbal learning, memory, and attention, as well as cognitive and functional performance will be measured.

Eligibility

Age

55 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Men and women aged ≥55 years.
•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.
+4 more criteria

Exclusion Criteria

•1. Diagnosis of any other ongoing central nervous system (CNS) condition other than DLB, including, but not limited to, post-stroke dementia, vascular dementia, Alzheimer's disease (AD), or Parkinson's disease (PD).
•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.
+4 more criteria

Locations (40)

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

Key Dates

Start Date

May 1, 2023

Primary Completion Date

October 4, 2024

Completion Date

June 16, 2025

Last Updated

January 7, 2026

Enrollment

159

ACTUAL participants

Conditions

Dementia With Lewy Bodies

Interventions

Neflamapimod

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 7, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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RewinD-LB - Clinical Study of Neflamapimod in Patients With Dementia With Lewy Bodies

Inclusion Criteria

Exclusion Criteria

[18F]F-DOPA Imaging in Patients With Autonomic Failure

PET Imaging Evaluation of [11C]SY08

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