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Could this pill boost brain function in lewy body dementia?

NCT ID NCT05869669

Symptom relief Sponsor: EIP Pharma Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 2 times

Summary

This study tested an experimental drug called neflamapimod in 159 people with dementia with Lewy bodies (DLB). The goal was to see if it could improve memory, problem-solving, and attention compared to a placebo. Participants took the drug or a dummy pill for a set period, and researchers measured changes in thinking and daily function.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

159 people

The number who actually took part.

Started

May 2023

Finished

Jun 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

55 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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. 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: 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. 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.

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Conditions

The condition(s) this trial relates to.

Lewy body dementia Lewy Body Disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Dementia with lewy bodies

Contacts and locations

Locations

  • AdventHealth Neuroscience Research

    Orlando, Florida, 32804, United States

  • Banner Alzheimer's Institute - Edson Family Lewy Body Dementia Center

    Tucson, Arizona, 85718, United States

  • Banner Sun Health Research Institute

    Sun City, Arizona, 85351, United States

  • Barrow Neurological Institute

    Phoenix, Arizona, 85013, United States

  • Belfast Health & Social Care Trust

    Belfast, BT12 6BA, United Kingdom

  • Brain Research Center - Amsterdam

    Amsterdam, 1081, Netherlands

  • Brain Research Center - Den Bosch

    's-Hertogenbosch, 5223, Netherlands

  • Brain Research Center - Zwolle

    Zwolle, 8025, Netherlands

  • Cambridgeshire and Peterborough NHS Foundation Trust, Fulbourn Hospital - Windsor Research Unit

    Cambridge, CB215EF, United Kingdom

  • Campus Ageing Research Unit (CARU) - Newcastle upon Tyne, CNTW NHS Foundation Trust

    Newcastle upon Tyne, NE4 5PL, United Kingdom

  • Center for Cognitive Health

    Portland, Oregon, 97225, United States

  • Cleveland Clinic - Center for Brain Health

    Cleveland, Ohio, 44195, United States

  • Cleveland Clinic - Lou Ruvo Center for Brain Health

    Las Vegas, Nevada, 89106, United States

  • ClinCloud

    Melbourne, Florida, 32940, United States

  • Columbia University - Taub Institute/Neurology Dept

    New York, New York, 10032, United States

  • Cornwall Partnership NHS Foundation Trust (University of Exeter)

    Redruth, TR15 3QE, United Kingdom

  • Georgetown Univ Hospital - Dept of Neurology

    Washington D.C., District of Columbia, 20007, United States

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, California, 92663, United States

  • Houston Methodist Hospital - Stanley Appel Neurology Dept

    Houston, Texas, 77030, United States

  • JEM Research Institute

    Lake Worth, Florida, 33462, United States

  • Johns Hopkins School of Medicine - Dept of Neurology

    Baltimore, Maryland, 21287, United States

  • Mass General Hospital/Harvard Medical School - Dept of Neurology

    Charlestown, Massachusetts, 02129, United States

  • Mayo Clinic - Alzheimer's Disease Research Center

    Rochester, Minnesota, 55905, United States

  • Memory Assessment and Research Centre (MARC) - Moorgreen Hospital

    Southampton, SO30 3JB, United Kingdom

  • NeuroScience Research Center

    Canton, Ohio, 44718, United States

  • Ohio State University - Dept of Neurology

    Columbus, Ohio, 43221, United States

  • Panhandle Research and Medical Clinic

    Pensacola, Florida, 32503, United States

  • Re:Cognition Health

    London, W1G9JF, United Kingdom

  • SC3 Research Group

    Pasadena, California, 91105, United States

  • Sana Research

    Arlington, Virginia, 22205, United States

  • South London and Maudsley NHS Foundation Trust

    London, SE5 8AF, United Kingdom

  • Stanford Neuroscience Health Center

    Palo Alto, California, 94304, United States

  • Tandem Clinical Research

    Marrero, Louisiana, 70072, United States

  • UCSD Health Sciences - Movement Disorders Center

    La Jolla, California, 92037, United States

  • University College London (UCL) Clinical Research Facility, University College London Hospitals NHS Foundation Trust

    London, WC1N 3BG, United Kingdom

  • University of Colorado - Dept of Neurology

    Aurora, Colorado, 80045, United States

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160, United States

  • University of Nebraska Medical Center - Dept of Neurological Sciences

    Omaha, Nebraska, 68198, United States

  • University of North Carolina - Dept of Neurology

    Chapel Hill, North Carolina, 27599, United States

  • Virginia Commonwealth University - Parkinson's and Movement Disorders Center

    Richmond, Virginia, 23298, United States

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