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
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.
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.
239 studies on the registry are indexed under Lewy Body Disease; 89 are open to participants now.
This study's enrollment of 159 is above the median of 89 across 152 interventional studies indexed under Lewy Body Disease.
Browse Lewy Body Disease studies →EIP Pharma Inc is the lead sponsor of 9 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 4 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Background dementia therapy:
Exclusion Criteria:
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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
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
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
Placebo is a capsule that looks just like neflamapimod but without the active ingredients
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
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
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
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
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
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
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
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
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
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.
| Milestone | Neflamapimod | Placebo | Neflamapimod Only Extension |
|---|---|---|---|
| Started | 79 | 80 | 0 |
| Completed | 75 | 77 | 0 |
| Not completed | 4 | 3 | 0 |
| Milestone | Neflamapimod | Placebo | Neflamapimod Only Extension |
|---|---|---|---|
| Started | 0 | 0 | 149 |
| Participants who received dp batch a >50% of the weeks, at week 16 in the extension phase | 0 | 0 | 55 |
| Participants who received dp batch b ≥ 50% of the weeks, at week 16 in the extension phase | 0 | 0 | 94 |
| Participants who received only dp batch a in the extension phase | 0 | 0 | 20 |
| Participants who received dp batch b for all or a portion of the extension phase | 0 | 0 | 129 |
| Participants who received dp batch a >50% of the weeks, at week 8 in the extension phase | 0 | 0 | 81 |
| Participants who received dp batch b ≥ 50% of the weeks, at week 8 in the extension phase | 0 | 0 | 68 |
| Completed | 0 | 0 | 122 |
| Not completed | 0 | 0 | 27 |
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.
| Scores on a scale | Neflamapimod | Placebo |
|---|---|---|
| Change in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) in Neflamapimod-treated Participants Compared to Placebo Recipients (Blinded Treatment Period) | 0.36 ± 0.193 | 0.34 ± 0.188 |
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.
| Scores on a scale | Extension Phase Batch A | Extension 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 ± 0.29 | 0.63 ± 0.21 |
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.
| Seconds | Neflamapimod | Placebo |
|---|---|---|
| Change in Timed Up and Go Test (TUG) in Neflamapimod-treated Participants Compared to Placebo Recipients (Blinded Treatment Period) | 0.28 ± 1.070 | 0.03 ± 1.030 |
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.
| Seconds | Extension Phase Batch A | Extension 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 ± 0.46 | 0.03 ± 0.36 |
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.
| Z-score | Neflamapimod | Placebo |
|---|---|---|
| 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 ± 0.052 | 0.07 ± 0.048 |
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.
| Z-score | Extension Phase Batch A | Extension 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 |
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.
| Scores on a scale | Neflamapimod | Placebo |
|---|---|---|
| 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 ± 0.93 | 4.5 ± 1.1 |
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.
| Scores on a scale | Extension Phase Batch A | Extension 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 ± 0.12 | 4.02 ± 0.15 |
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
| pg/mL | Extension Phase Batch A | Extension 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) |
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.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Neflamapimod | 0/79 (0%) | 5/79 (6.3%) | 58/79 (73.4%) |
| Placebo | 2/80 (2.5%) | 8/80 (10%) | 58/80 (72.5%) |
| Open-label Extension | 2/149 (1.3%) | 22/149 (14.8%) | 61/149 (40.9%) |
| Event | Neflamapimod | Placebo | Open-label Extension |
|---|---|---|---|
| SyncopeNervous system disorders | 0/79 | 0/80 | 3/149 |
| Urinary tract infectionInfections and infestations | 1/79 | 1/80 | 2/149 |
| Mental status changesPsychiatric disorders | 0/79 | 0/80 | 2/149 |
| FallInjury, poisoning and procedural complications | 0/79 | 0/80 | 2/149 |
| COVID-19Infections and infestations | 1/79 | 0/80 | 1/149 |
| PneumoniaInfections and infestations | 1/79 | 0/80 | 0/149 |
| Colitis ischemicGastrointestinal disorders | 1/79 | 0/80 | 0/149 |
| DehydrationMetabolism and nutrition disorders | 1/79 | 0/80 | 0/149 |
| Pleural effusionRespiratory, thoracic and mediastinal disorders | 1/79 | 0/80 | 0/149 |
| AgitationPsychiatric disorders | 0/79 | 1/80 | 1/149 |
| Event | Neflamapimod | Placebo | Open-label Extension |
|---|---|---|---|
| FallInjury, poisoning and procedural complications | 12/79 | 15/80 | 25/149 |
| HeadacheNervous system disorders | 5/79 | 10/80 | 7/149 |
| COVID-19Infections and infestations | 8/79 | 3/80 | 9/149 |
| DiarrheaGastrointestinal disorders | 6/79 | 3/80 | 8/149 |
| Urinary tract infectionInfections and infestations | 5/79 | 6/80 | 11/149 |
| FatigueGeneral disorders | 5/79 | 6/80 | 7/149 |
| Upper respiratory tract infectionInfections and infestations | 5/79 | 4/80 | 6/149 |
| HallucinationPsychiatric disorders | 2/79 | 5/80 | 8/149 |
| DizzinessNervous system disorders | 4/79 | 3/80 | 7/149 |
| Confusional statePsychiatric disorders | 4/79 | 1/80 | 5/149 |
Baseline characteristics were collected at baseline of the blinded (randomized) period.
| Age, Continuous(years) | Neflamapimod | Placebo | Total |
|---|---|---|---|
| Mean | 72.1 ± 6.4 | 70.7 ± 5.8 | 71.4 ± 6.1 |
| Sex: Female, Male(Participants) | Neflamapimod | Placebo | Total |
|---|---|---|---|
| Female | 10 | 13 | 23 |
| Male | 69 | 67 | 136 |
| Race (NIH/OMB)(Participants) | Neflamapimod | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Black or African American | 2 | 2 | 4 |
| White | 74 | 76 | 150 |
| More than one race | 1 | 0 | 1 |
| Unknown or Not Reported | 1 | 1 | 2 |
| Ethnicity (NIH/OMB)(Participants) | Neflamapimod | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 5 | 2 | 7 |
| Not Hispanic or Latino | 74 | 78 | 152 |
| Unknown or Not Reported | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
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Studies of the drug tested here: VX-745
EIP Pharma Inc