CClinicalTrials.gg
Sign In
CompletedNCT05869669Updated Sep 3, 2026Results posted

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

A Phase 2 interventional study of Neflamapimod and Placebo in Dementia With Lewy Bodies, sponsored by EIP Pharma Inc. Completed at 40 sites in 3 countries. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2026-09-03.

Sponsored by EIP Pharma Inc · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
159
Allocation
Randomized
Ages
55 Years and older
Sex
All
01

Study 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.

Read the detailed description

This study includes a 16-week blinded treatment period (randomized 1:1 neflamapimod:placebo) and a 32 week open-label extension during which all participants receive neflamapimod.

02

Conditions studied

  • Dementia With Lewy Bodies

Browse trials for

Keywords

  • DLB
03

Who can participate

Ages eligible
55 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.

04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
159 participants (actual)

Study arms

  • Active comparator
    Neflamapimod

    Neflamapimod will be administered with food for 16 weeks in participants with DLB. Participants will receive 3 capsules per day (TID) with food (i.e., with the morning, mid-day and evening meals).

    Drug: Neflamapimod

  • Placebo comparator
    Placebo

    Placebo will be administered with food for 16 weeks in participants with DLB. Participants will receive 3 capsules per day (TID) with food (i.e., with the morning, mid-day and evening meals).

    Drug: Placebo

  • Experimental
    Open-label extension

    Neflamapimod will be administered with food for 32 weeks in participants with DLB who have completed the blinded treatment period. Participants will receive 3 capsules per day (TID) with food (i.e., with the morning, mid-day and evening meals).

    Drug: Neflamapimod

Interventions

  • DrugNeflamapimod

    Neflamapimod is a highly specific inhibitor of the intra-cellular enzyme mitogen-activated protein kinase14 (p38α) provided in 40mg capsules

    Also known as: VX-745

  • DrugPlacebo

    Placebo is a capsule that looks just like neflamapimod but without the active ingredients

05

What researchers measure

Primary outcomes

  1. Change in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) in Neflamapimod-treated Participants Compared to Placebo Recipients (Blinded Treatment Period)

    Evaluate the efficacy of neflamapimod, compared to placebo, as a treatment for DLB, as assessed by the CDR-SB scale. CDR-SB scores range from 0 to 18 with a higher score indicating worsening of cognitive impairment.

    Time frame: 16 weeks

Secondary outcomes

  1. Change in Timed Up and Go Test (TUG) in Neflamapimod-treated Participants Compared to Placebo Recipients (Blinded Treatment Period)

    Evaluate if neflamapimod improves motor function in participants with DLB, compared to placebo, as assessed by the TUG test. TUG scores typically range from 6 to 20 seconds with a higher score indicating worse mobility. A score of \>15 indicates an increased risk of falls.

    Time frame: 16 weeks

  2. Change in the Composite Score of the Neuropsychological Test Battery (NTB), Including Tests of Attention, Executive Function, and Visual Learning in Neflamapimod-treated Participants Compared to Placebo Recipients (Blinded Treatment Period)

    Evaluate if neflamapimod improves cognition, compared to placebo, as assessed by a DLB-specific NTB in participants with DLB. NTB includes Cogstate Detection test (DET), Cogstate Identification test (IDN), Cogstate One Card Learning test (OCL), Cogstate One Back test (ONB). Each score on the individual tests is converted to a z-score, and then a total z-score for the composite is calculated, in which each test is weighted equally. As the analysis is based on z-scores, there is no minimum or maximum value. A z-score of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. A positive change in z-score indicates an improvement in cognition and a negative change in z-score indicates a worsening in cognition.

    Time frame: 16 weeks

  3. Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-GCIC) Score at Week 16 in Neflamapimod-treated Participants Compared to Placebo Recipients (Blinded Treatment Period)

    Evaluate if neflamapimod improves global (cognition, function and behavior) disease status evaluated by a clinician with caregiver input, compared to placebo, in participants with DLB, as assessed ADCS-CGIC score. ADCS-CGIC scores range from 1 to 7, where 1 = marked improvement, 2= moderate improvement, 3 = minimal improvement, 4 = no change, 5 = minimal worsening, 6 = moderate worsening, and 7 = marked worsening.

    Time frame: 16 weeks

Other outcomes

  1. Change in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) in Neflamapimod-treated Participants, DP Batch A Compared to DP Batch B (1st 16 Weeks of Extension Phase)

    Evaluate the efficacy of neflamapimod, in recipients of Drug Product (DP) Batch A compared to Drug Product (DP) Batch B, as a treatment for DLB, as assessed by the CDR-SB scale. CDR-SB scores range from 0 to 18 with a higher score indicating worsening of cognitive impairment.

    Time frame: 16 weeks of the extension phase

  2. Change in Timed Up and Go Test (TUG) in Neflamapimod-treated Participants, DP Batch A Compared to DP Batch B (1st 16 Weeks of Extension Phase)

    Evaluate if neflamapimod improves motor function in participants with DLB, in recipients of Drug Batch A compared to Drug Batch B, as assessed by the TUG test. TUG scores typically range from 6 to 20 seconds with a higher score indicating worse mobility. A score of \>15 indicates an increased risk of falls.

    Time frame: 16 weeks of the extension phase

  3. Change in the Composite Score of the Neuropsychological Test Battery (NTB), Including Tests of Attention, Executive Function, and Visual Learning in Neflamapimod-treated Participants, DP Batch A Compared to DP Batch B (1st 16 Weeks of Extension Phase)

    Evaluate if neflamapimod improves cognition, in recipients of Drug Product (DP) Batch A compared to Drug Product (DP) Batch B as assessed by a DLB-specific NTB in participants with DLB. NTB includes Cogstate Detection test (DET), Cogstate Identification test (IDN), Cogstate One Card Learning test (OCL), Cogstate One Back test (ONB). Each score on the individual tests is converted to a z-score, and then a total z-score for the composite is calculated, in which each test is weighted equally. As the analysis is based on z-scores, there is no minimum or maximum value. A z-score of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. A positive change in z-score indicates an improvement in cognition and a negative change in z-score indicates a worsening in cognition.

    Time frame: 16 weeks of the extension phase

  4. Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) Score at Week 8 in Neflamapimod-treated Participants, DP Batch A Compared to DP Batch B (Extension Phase)

    Evaluate if neflamapimod improves global (cognition, function and behavior) disease status evaluated by a clinician with caregiver input, in recipients of Drug Product (DP) Batch A compared to Drug Product (DP) Batch B, in patients with DLB, as assessed ADCS-CGIC score. ADCS-CGIC scores range from 1 to 7, where 1 = marked improvement, 2= moderate improvement, 3 = minimal improvement, 4 = no change, 5 = minimal worsening, 6 = moderate worsening, and 7 = marked worsening.

    Time frame: 8 weeks

  5. Exploratory Outcome - Plasma Biomarker, Glial Fibrillary Acidic Protein (GFAP), Measurement at Week 32 (Extension Phase)

    Change from Start of Extension Phase in GFAP levels in neflamapimod-treated participants, Drug Product (DP) Batch A compared to Drug Product (DP) Batch B, over 32 weeks. GFAP in plasma is measured in pg/mL (picograms per milliliter) and a reduction in levels is associated with clinical improvement

    Time frame: 32 weeks

06

Results

Posted Sep 3, 2026

Participant flow

From July 2023 to June 2024, 335 participants were recruited for screening, of which 159 were randomized at 40 centers in the United States, United Kingdom, and Netherlands.

Blinded (randomized) Period
Participant flow — Blinded (randomized) Period
MilestoneNeflamapimodPlaceboNeflamapimod Only Extension
Started79800
Completed75770
Not completed430
Extension Phase
Participant flow — Extension Phase
MilestoneNeflamapimodPlaceboNeflamapimod Only Extension
Started00149
Participants who received dp batch a >50% of the weeks, at week 16 in the extension phase0055
Participants who received dp batch b ≥ 50% of the weeks, at week 16 in the extension phase0094
Participants who received only dp batch a in the extension phase0020
Participants who received dp batch b for all or a portion of the extension phase00129
Participants who received dp batch a >50% of the weeks, at week 8 in the extension phase0081
Participants who received dp batch b ≥ 50% of the weeks, at week 8 in the extension phase0068
Completed00122
Not completed0027

Outcome measures

PrimaryChange in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) in Neflamapimod-treated Participants Compared to Placebo Recipients (Blinded Treatment Period)

Evaluate the efficacy of neflamapimod, compared to placebo, as a treatment for DLB, as assessed by the CDR-SB scale. CDR-SB scores range from 0 to 18 with a higher score indicating worsening of cognitive impairment.

Time frame:
16 weeks
Reported as:
Least squares mean · Scores on a scale
Change in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) in Neflamapimod-treated Participants Compared to Placebo Recipients (Blinded Treatment Period)
Scores on a scaleNeflamapimodPlacebo
Change in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) in Neflamapimod-treated Participants Compared to Placebo Recipients (Blinded Treatment Period)0.36 ± 0.1930.34 ± 0.188
Statistical analysis
  • Neflamapimod vs Placebo · Mixed Models Analysis · p = 0.9448 · Mean difference (final values): 0.01 · 95% CI -0.37 to 0.40
Other pre-specifiedChange in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) in Neflamapimod-treated Participants, DP Batch A Compared to DP Batch B (1st 16 Weeks of Extension Phase)

Evaluate the efficacy of neflamapimod, in recipients of Drug Product (DP) Batch A compared to Drug Product (DP) Batch B, as a treatment for DLB, as assessed by the CDR-SB scale. CDR-SB scores range from 0 to 18 with a higher score indicating worsening of cognitive impairment.

Time frame:
16 weeks of the extension phase
Reported as:
Mean · Scores on a scale
Change in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) in Neflamapimod-treated Participants, DP Batch A Compared to DP Batch B (1st 16 Weeks of Extension Phase)
Scores on a scaleExtension Phase Batch AExtension Phase Batch B
Change in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) in Neflamapimod-treated Participants, DP Batch A Compared to DP Batch B (1st 16 Weeks of Extension Phase)1.1 ± 0.290.63 ± 0.21
Statistical analysis
  • Extension Phase Batch A vs Extension Phase Batch B · Mixed Models Analysis · p = 0.007 · Mean difference (final values): -0.57 · 95% CI -0.98 to -0.16
SecondaryChange in Timed Up and Go Test (TUG) in Neflamapimod-treated Participants Compared to Placebo Recipients (Blinded Treatment Period)

Evaluate if neflamapimod improves motor function in participants with DLB, compared to placebo, as assessed by the TUG test. TUG scores typically range from 6 to 20 seconds with a higher score indicating worse mobility. A score of \>15 indicates an increased risk of falls.

Time frame:
16 weeks
Reported as:
Least squares mean · Seconds
Change in Timed Up and Go Test (TUG) in Neflamapimod-treated Participants Compared to Placebo Recipients (Blinded Treatment Period)
SecondsNeflamapimodPlacebo
Change in Timed Up and Go Test (TUG) in Neflamapimod-treated Participants Compared to Placebo Recipients (Blinded Treatment Period)0.28 ± 1.0700.03 ± 1.030
Statistical analysis
  • Neflamapimod vs Placebo · Mixed Models Analysis · p = 0.8195 · Mean difference (final values): 0.25 · 95% CI -1.93 to 2.44
Other pre-specifiedChange in Timed Up and Go Test (TUG) in Neflamapimod-treated Participants, DP Batch A Compared to DP Batch B (1st 16 Weeks of Extension Phase)

Evaluate if neflamapimod improves motor function in participants with DLB, in recipients of Drug Batch A compared to Drug Batch B, as assessed by the TUG test. TUG scores typically range from 6 to 20 seconds with a higher score indicating worse mobility. A score of \>15 indicates an increased risk of falls.

Time frame:
16 weeks of the extension phase
Reported as:
Mean · Seconds
Change in Timed Up and Go Test (TUG) in Neflamapimod-treated Participants, DP Batch A Compared to DP Batch B (1st 16 Weeks of Extension Phase)
SecondsExtension Phase Batch AExtension Phase Batch B
Change in Timed Up and Go Test (TUG) in Neflamapimod-treated Participants, DP Batch A Compared to DP Batch B (1st 16 Weeks of Extension Phase)0.85 ± 0.460.03 ± 0.36
Statistical analysis
  • Extension Phase Batch A vs Extension Phase Batch B · Mixed Models Analysis · p = 0.747 · Mean difference (final values): -0.120 · 95% CI -0.85 to 0.61
SecondaryChange in the Composite Score of the Neuropsychological Test Battery (NTB), Including Tests of Attention, Executive Function, and Visual Learning in Neflamapimod-treated Participants Compared to Placebo Recipients (Blinded Treatment Period)

Evaluate if neflamapimod improves cognition, compared to placebo, as assessed by a DLB-specific NTB in participants with DLB. NTB includes Cogstate Detection test (DET), Cogstate Identification test (IDN), Cogstate One Card Learning test (OCL), Cogstate One Back test (ONB). Each score on the individual tests is converted to a z-score, and then a total z-score for the composite is calculated, in which each test is weighted equally. As the analysis is based on z-scores, there is no minimum or maximum value. A z-score of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. A positive change in z-score indicates an improvement in cognition and a negative change in z-score indicates a worsening in cognition.

Time frame:
16 weeks
Reported as:
Least squares mean · Z-score
Change in the Composite Score of the Neuropsychological Test Battery (NTB), Including Tests of Attention, Executive Function, and Visual Learning in Neflamapimod-treated Participants Compared to Placebo Recipients (Blinded Treatment Period)
Z-scoreNeflamapimodPlacebo
Change in the Composite Score of the Neuropsychological Test Battery (NTB), Including Tests of Attention, Executive Function, and Visual Learning in Neflamapimod-treated Participants Compared to Placebo Recipients (Blinded Treatment Period)0.05 ± 0.0520.07 ± 0.048
Statistical analysis
  • Neflamapimod vs Placebo · Mixed Models Analysis · p = 0.7345 · Mean difference (final values): -0.02 · 95% CI -0.12 to 0.08
Other pre-specifiedChange in the Composite Score of the Neuropsychological Test Battery (NTB), Including Tests of Attention, Executive Function, and Visual Learning in Neflamapimod-treated Participants, DP Batch A Compared to DP Batch B (1st 16 Weeks of Extension Phase)

Evaluate if neflamapimod improves cognition, in recipients of Drug Product (DP) Batch A compared to Drug Product (DP) Batch B as assessed by a DLB-specific NTB in participants with DLB. NTB includes Cogstate Detection test (DET), Cogstate Identification test (IDN), Cogstate One Card Learning test (OCL), Cogstate One Back test (ONB). Each score on the individual tests is converted to a z-score, and then a total z-score for the composite is calculated, in which each test is weighted equally. As the analysis is based on z-scores, there is no minimum or maximum value. A z-score of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. A positive change in z-score indicates an improvement in cognition and a negative change in z-score indicates a worsening in cognition.

Time frame:
16 weeks of the extension phase
Reported as:
Mean · Z-score
Change in the Composite Score of the Neuropsychological Test Battery (NTB), Including Tests of Attention, Executive Function, and Visual Learning in Neflamapimod-treated Participants, DP Batch A Compared to DP Batch B (1st 16 Weeks of Extension Phase)
Z-scoreExtension Phase Batch AExtension Phase Batch B
Change in the Composite Score of the Neuropsychological Test Battery (NTB), Including Tests of Attention, Executive Function, and Visual Learning in Neflamapimod-treated Participants, DP Batch A Compared to DP Batch B (1st 16 Weeks of Extension Phase)-0.09 ± 0.08-0.06 ± 0.05
Statistical analysis
  • Extension Phase Batch A vs Extension Phase Batch B · Mixed Models Analysis · p = 0.425 · Mean difference (final values): 0.05 · 95% CI -0.08 to 0.18
SecondaryAlzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-GCIC) Score at Week 16 in Neflamapimod-treated Participants Compared to Placebo Recipients (Blinded Treatment Period)

Evaluate if neflamapimod improves global (cognition, function and behavior) disease status evaluated by a clinician with caregiver input, compared to placebo, in participants with DLB, as assessed ADCS-CGIC score. ADCS-CGIC scores range from 1 to 7, where 1 = marked improvement, 2= moderate improvement, 3 = minimal improvement, 4 = no change, 5 = minimal worsening, 6 = moderate worsening, and 7 = marked worsening.

Time frame:
16 weeks
Reported as:
Mean · Scores on a scale
Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-GCIC) Score at Week 16 in Neflamapimod-treated Participants Compared to Placebo Recipients (Blinded Treatment Period)
Scores on a scaleNeflamapimodPlacebo
Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-GCIC) Score at Week 16 in Neflamapimod-treated Participants Compared to Placebo Recipients (Blinded Treatment Period)4.4 ± 0.934.5 ± 1.1
Statistical analysis
  • Neflamapimod vs Placebo · Wilcoxon (Mann-Whitney) · p = 0.7418 · Mean difference (final values): -0.3294
Other pre-specifiedAlzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) Score at Week 8 in Neflamapimod-treated Participants, DP Batch A Compared to DP Batch B (Extension Phase)

Evaluate if neflamapimod improves global (cognition, function and behavior) disease status evaluated by a clinician with caregiver input, in recipients of Drug Product (DP) Batch A compared to Drug Product (DP) Batch B, in patients with DLB, as assessed ADCS-CGIC score. ADCS-CGIC scores range from 1 to 7, where 1 = marked improvement, 2= moderate improvement, 3 = minimal improvement, 4 = no change, 5 = minimal worsening, 6 = moderate worsening, and 7 = marked worsening.

Time frame:
8 weeks
Reported as:
Mean · Scores on a scale
Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) Score at Week 8 in Neflamapimod-treated Participants, DP Batch A Compared to DP Batch B (Extension Phase)
Scores on a scaleExtension Phase Batch AExtension Phase Batch B
Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) Score at Week 8 in Neflamapimod-treated Participants, DP Batch A Compared to DP Batch B (Extension Phase)4.42 ± 0.124.02 ± 0.15
Statistical analysis
  • Extension Phase Batch A vs Extension Phase Batch B · Wilcoxon (Mann-Whitney) · p = 0.033 · Mean difference (final values): -0.40 · 95% CI -0.77 to -0.04
Other pre-specifiedExploratory Outcome - Plasma Biomarker, Glial Fibrillary Acidic Protein (GFAP), Measurement at Week 32 (Extension Phase)

Change from Start of Extension Phase in GFAP levels in neflamapimod-treated participants, Drug Product (DP) Batch A compared to Drug Product (DP) Batch B, over 32 weeks. GFAP in plasma is measured in pg/mL (picograms per milliliter) and a reduction in levels is associated with clinical improvement

Time frame:
32 weeks
Reported as:
Mean · pg/mL
Exploratory Outcome - Plasma Biomarker, Glial Fibrillary Acidic Protein (GFAP), Measurement at Week 32 (Extension Phase)
pg/mLExtension Phase Batch AExtension Phase Batch B
Exploratory Outcome - Plasma Biomarker, Glial Fibrillary Acidic Protein (GFAP), Measurement at Week 32 (Extension Phase)10.49 (-6.472 to 27.45)-18.4 (-26.18 to -10.62)
Statistical analysis
  • Extension Phase Batch A vs Extension Phase Batch B · Wilcoxon (Mann-Whitney) · p = 0.014 · Mean difference (final values): -28.89 · 95% CI -53.1 to -4.69

Adverse events

Collected over Adverse events (AEs) occurring from when the subject signed the informed consent form (ICF) until the last study event were collected, up to 55 weeks in duration.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Neflamapimod0/79 (0%)5/79 (6.3%)58/79 (73.4%)
Placebo2/80 (2.5%)8/80 (10%)58/80 (72.5%)
Open-label Extension2/149 (1.3%)22/149 (14.8%)61/149 (40.9%)
Most frequent serious events
Showing 10 of 37
Most frequent serious events
EventNeflamapimodPlaceboOpen-label Extension
SyncopeNervous system disorders0/790/803/149
Urinary tract infectionInfections and infestations1/791/802/149
Mental status changesPsychiatric disorders0/790/802/149
FallInjury, poisoning and procedural complications0/790/802/149
COVID-19Infections and infestations1/790/801/149
PneumoniaInfections and infestations1/790/800/149
Colitis ischemicGastrointestinal disorders1/790/800/149
DehydrationMetabolism and nutrition disorders1/790/800/149
Pleural effusionRespiratory, thoracic and mediastinal disorders1/790/800/149
AgitationPsychiatric disorders0/791/801/149
Most frequent other events
Showing 10 of 12
Most frequent other events
EventNeflamapimodPlaceboOpen-label Extension
FallInjury, poisoning and procedural complications12/7915/8025/149
HeadacheNervous system disorders5/7910/807/149
COVID-19Infections and infestations8/793/809/149
DiarrheaGastrointestinal disorders6/793/808/149
Urinary tract infectionInfections and infestations5/796/8011/149
FatigueGeneral disorders5/796/807/149
Upper respiratory tract infectionInfections and infestations5/794/806/149
HallucinationPsychiatric disorders2/795/808/149
DizzinessNervous system disorders4/793/807/149
Confusional statePsychiatric disorders4/791/805/149

Baseline characteristics

Baseline characteristics were collected at baseline of the blinded (randomized) period.

Age, Continuous
Age, Continuous(years)NeflamapimodPlaceboTotal
Mean72.1 ± 6.470.7 ± 5.871.4 ± 6.1
Sex: Female, Male
Sex: Female, Male(Participants)NeflamapimodPlaceboTotal
Female101323
Male6967136
Race (NIH/OMB)
Race (NIH/OMB)(Participants)NeflamapimodPlaceboTotal
American Indian or Alaska Native000
Asian101
Native Hawaiian or Other Pacific Islander011
Black or African American224
White7476150
More than one race101
Unknown or Not Reported112
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)NeflamapimodPlaceboTotal
Hispanic or Latino527
Not Hispanic or Latino7478152
Unknown or Not Reported000
07

Study locations

40 sites
  • Barrow Neurological Institute
    Phoenix, Arizona 85013, United States
  • Banner Sun Health Research Institute
    Sun City, Arizona 85351, United States
  • Banner Alzheimer's Institute - Edson Family Lewy Body Dementia Center
    Tucson, Arizona 85718, United States
  • UCSD Health Sciences - Movement Disorders Center
    La Jolla, California 92037, United States
  • Hoag Memorial Hospital Presbyterian
    Newport Beach, California 92663, United States
  • Stanford Neuroscience Health Center
    Palo Alto, California 94304, United States
  • SC3 Research Group
    Pasadena, California 91105, United States
  • University of Colorado - Dept of Neurology
    Aurora, Colorado 80045, United States
  • Georgetown Univ Hospital - Dept of Neurology
    Washington D.C., District of Columbia 20007, United States
  • JEM Research Institute
    Lake Worth, Florida 33462, United States
  • ClinCloud
    Melbourne, Florida 32940, United States
  • AdventHealth Neuroscience Research
    Orlando, Florida 32804, United States
  • Panhandle Research and Medical Clinic
    Pensacola, Florida 32503, United States
  • University of Kansas Medical Center
    Kansas City, Kansas 66160, United States
  • Tandem Clinical Research
    Marrero, Louisiana 70072, 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
  • University of Nebraska Medical Center - Dept of Neurological Sciences
    Omaha, Nebraska 68198, United States
  • Cleveland Clinic - Lou Ruvo Center for Brain Health
    Las Vegas, Nevada 89106, United States
  • Columbia University - Taub Institute/Neurology Dept
    New York, New York 10032, United States
  • University of North Carolina - Dept of Neurology
    Chapel Hill, North Carolina 27599, United States
  • NeuroScience Research Center
    Canton, Ohio 44718, United States
  • Cleveland Clinic - Center for Brain Health
    Cleveland, Ohio 44195, United States
  • Ohio State University - Dept of Neurology
    Columbus, Ohio 43221, United States
  • Center for Cognitive Health
    Portland, Oregon 97225, United States
  • Houston Methodist Hospital - Stanley Appel Neurology Dept
    Houston, Texas 77030, United States
  • Sana Research
    Arlington, Virginia 22205, United States
  • Virginia Commonwealth University - Parkinson's and Movement Disorders Center
    Richmond, Virginia 23298, United States
  • Brain Research Center - Den Bosch
    's-Hertogenbosch, 5223, Netherlands
  • Brain Research Center - Amsterdam
    Amsterdam, 1081, Netherlands
  • Brain Research Center - Zwolle
    Zwolle, 8025, Netherlands
  • Belfast Health & Social Care Trust
    Belfast, BT12 6BA, United Kingdom
  • Cambridgeshire and Peterborough NHS Foundation Trust, Fulbourn Hospital - Windsor Research Unit
    Cambridge, CB215EF, United Kingdom
  • South London and Maudsley NHS Foundation Trust
    London, SE5 8AF, United Kingdom
  • Re:Cognition Health
    London, W1G9JF, United Kingdom
  • University College London (UCL) Clinical Research Facility, University College London Hospitals NHS Foundation Trust
    London, WC1N 3BG, United Kingdom
  • Campus Ageing Research Unit (CARU) - Newcastle upon Tyne, CNTW NHS Foundation Trust
    Newcastle upon Tyne, NE4 5PL, United Kingdom
  • Cornwall Partnership NHS Foundation Trust (University of Exeter)
    Redruth, TR15 3QE, United Kingdom
  • Memory Assessment and Research Centre (MARC) - Moorgreen Hospital
    Southampton, SO30 3JB, United Kingdom
08

References and documents

Publications

  • Prins ND, de Haan W, Gardner A, Blackburn K, Chu HM, Galvin JE, Alam JJ. Phase 2A Learnings Incorporated into RewinD-LB, a Phase 2B Clinical Trial of Neflamapimod in Dementia with Lewy Bodies. J Prev Alzheimers Dis. 2024;11(3):549-557. doi: 10.14283/jpad.2024.36. PubMed 38706271 ↗

Study documents

  • Study protocol · Jun 20, 2023
  • Study protocol · Dec 15, 2023
  • Statistical analysis plan · Oct 17, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT05869669
Lead sponsor
EIP Pharma Inc
Collaborators
National Institute on Aging (NIA), Worldwide Clinical Trials, CervoMed, Inc.
Responsible party
Sponsor
First posted
May 22, 2023
Start date
May 1, 2023
Primary completion
May 29, 2025
Completion
Jun 16, 2025
Results posted
Sep 3, 2026
Last update
Sep 3, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Lewy Body Disease→

Other studies from this sponsor

EIP Pharma Inc

Start the discussion