Trial · NCT04001517
Cognitive Effects of Oral p38 Alpha Kinase Inhibitor Neflamapimod in Dementia With Lewy Bodies
NCT04001517, Phase 2, Completed, EIP Pharma Inc; results first posted 2021-11-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Cognitive Effects of Oral p38 Alpha Kinase Inhibitor Neflamapimod in Dementia With Lewy Bodies. Trials, record NCT04001517. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04001517
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cognitive Effects of Oral p38 Alpha Kinase Inhibitor Neflamapimod in Dementia With Lewy Bodies
- NCT number
- NCT04001517
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 91 participants, actual
- Lead sponsor
- EIP Pharma Inc
- Conditions
- Dementia With Lewy Bodies (DLB)
- Interventions
- Neflamapimod
- First posted
- 2019-06-28
- Last updated
- 2023-06-29
- Results first posted
- 2021-11-02
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Composite Z-score of a Study-specific Neuropsychological Test Battery (NTB) Including Tests From Cogstate Battery, Letter Fluency Test and Category Fluency Test | As the analysis was by Mixed Model for Repeated Measures, all time points at which NTB was assessed utilized in the analysis. The difference reported is the mean difference over the entire course of the study. | Change from Baseline to Week 4, Week 8, and Week 16 in the composite z-score of a study-specific Neuropsychological Test Battery (NTB) that included the following six tests: Cogstate Detection test (DET), Cogstate Identification test (IDN), Cogstate One Card Learning test (OCL), Cogstate One Back test (ONB), Letter Fluency Test, and Category Fluency Test (CFT). Each score on the individual tests was converted to a z-score, and then a total z-score for the composite was 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 indicate an improvement in cognition, i.e., a better outcome; and a negative change in z-score indicates a worsening in cognition, i.e., a worse outcome. |
| Secondary | Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) | As the analysis was by Mixed Model for Repeated Measures, both time points at which CDR-SB was assessed (week 8 and 16) was utilized in the analysis. The difference reported is the mean difference over the entire course of the study. | Change in Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) score from Baseline to Week 8 and Week 16 based on semi-quantitative scoring of six domains (i.e., "box": 1) memory, 2) orientation, 3) judgement \& reasoning, 4) home \& hobbies, 5) community affairs, and 6) personal care. The CDR score ranges from 0 (no impairment), 0.5 (questionable impairment), 1 (mild impairment), 2 (moderate impairment), and 3 (severe impairment). The domain (box) scores are then added for a Sum of Boxes score. With six domains, the CDR-SB score then ranges from 0 to 18; with higher scores indicated worse outcomes. |
| Secondary | Mini-Mental State Examination (MMSE) | As the analysis was by Mixed Model for Repeated Measures, both time points at which MMSE was assessed (week 8 and 16) was utilized in the analysis. The difference reported is the mean difference over the entire course of the study. | The Mini-Mental State Examination (MMSE) is a general measure of cognition that assesses orientation, memory, concentration, language, and praxis. Scores range from 0 to 30 with lower scores indicating greater cognitive impairment, i.e. a worse outcome). The MMSE was assessed at Week 8 and Week 16 during the study. |
| Secondary | Neuropsychiatric Inventory (NPI-10) - Mean Change in Hallucinations Domain Score | As the analysis was by Mixed Model for Repeated Measures, all time points at which NPI-10 was assessed (weeks 4, 8 and 16) was utilized in the analysis. The difference reported is the mean difference over the entire course of the study. | The NPI-10 consists evaluates ten domains: delusions, hallucinations, agitation/aggression, dysphoria, anxiety, euphoria, apathy, disinhibition, irritability/lability, and aberrant motor activity. If caregiver reports symptoms within a domain then the caregiver rates the frequency of the symptoms on a 4-point scale, and severity on a 3-point scale. Total score for each domain is the frequency score multiplied by the severity score; i.e. the domain score (e.g. for hallucinations) for any one domain ranges from 0-12, with higher scores indicating worsening. A secondary objective of this study was to evaluate the effect of neflamapimod in four specific domains, specifically depression (dysphoria), anxiety, hallucinations, and agitation/aggression, in neflamapimod-treated subjects compared to placebo-recipients. Of these four, the only domain in which more than one-quarter of the patients reported symptoms is hallucinations, and the result of this analysis is reported. |
| Secondary | International Shopping List Test (ISLT) - Immediate Recall | As the analysis was by Mixed Model for Repeated Measures, both time points at which ISLT was assessed (Weeks 4, 8 and 16) was utilized in the analysis. The difference reported is the mean difference over the entire course of the study. | The International Shopping List Test (ISLT) was developed specifically to assess verbal list learning and memory in people from different language and cultural backgrounds. 12 words, consisting to items typically in a grocery shopping list in the specific culture are provided verbally, and subject asked to recall ask many words as possible. The immediate recall score consists of the number of words that the subject correctly repeats during three consecutive trials immediately following provision of words. The range is then from 0 to 36 (12 words maximum in each of 3 trials), with higher scores (i.e., the more words recalled) reflecting better outcomes. |
| Secondary | Timed Up and Go Test (TUG) | As the analysis was by Mixed Model for Repeated Measures, both time points at which the TUG was assessed (week 8 and 16) was utilized in the analysis. The difference reported is the mean difference over the entire course of the study. | The Timed Up and Go test assesses function mobility, and was included in the study to evaluate the effects of neflamapimod on motor function. The TUG measures the time in seconds that a person takes to rise from a chair, walk three meters, turn around 180 degrees, walk back to the chair, and sit down while turning 180 degrees. The TUG was evaluated at Baseline, and Weeks 8 and 16 of the study. There is no minimum or maximum value for this test, though in Parkinson's disease patients values above 11.5 seconds was associated with an increased risk of falls and each one second increase in the time required to complete the TUG is associated with a 5.4% increase in the risk of falls (Arch Phys Med Rehabil. 2013;94: 1300-1305). That is, an increase in the time required to complete the TUG is a worse outcome. |
| Secondary | Quantitative Electroencephalogram (qEEG)m - Dominant Peak Frequency Over Parietal Lobe | 16 weeks | Change in quantitative electroencephalogram (qEEG) parameters with the subject awake in accordance with the 10-20 International System of Electrode placement was to be evaluated as a potential biomarker for DLB. However, due to COVID19 related restrictions, baseline and week 16 EEG recordings were obtained only in limited number of subjects. As slowing of the dominant frequency band by qEEG over posterior aspects of the brain has been recognized to be prominent in DLB, the change in the dominant frequency band over the parietal lobe in Hz from baseline to week 16 is reported. This is a continuous variable with no minimum or maximum. A decrease in the frequency (i.e., slowing) reflects worsening of disease, while a positive treatment effect would be an increase in the frequency. With the limited number of subjects formal statistical analysis was not conducted. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Composite Z-score of a Study-specific Neuropsychological Test Battery (NTB) Including Tests From Cogstate Battery, Letter Fluency Test and Category Fluency Test | As the analysis was by Mixed Model for Repeated Measures, all time points at which NTB was assessed utilized in the analysis. The difference reported is the mean difference over the entire course of the study. | All subjects with a baseline and at least one on-treatment NTB evaluation. As placebo given twice or three times a day would not be expected to differences in outcome, per the protocol and statistical analysis plan (SAP) the placebo group was considered as one group, regardless of whether they received placebo BID or TID. | Z-Score | MEAN |
| SECONDARY | Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) | As the analysis was by Mixed Model for Repeated Measures, both time points at which CDR-SB was assessed (week 8 and 16) was utilized in the analysis. The difference reported is the mean difference over the entire course of the study. | All subjects with a baseline and at least one on-treatment CDR-SB evaluation. As placebo given twice or three times a day would not be expected to differences in outcome, per the protocol and statistical analysis plan (SAP) the placebo group was considered as one group, regardless of whether they received placebo BID or TID. | Scores on a scale | MEAN |
| SECONDARY | Mini-Mental State Examination (MMSE) | As the analysis was by Mixed Model for Repeated Measures, both time points at which MMSE was assessed (week 8 and 16) was utilized in the analysis. The difference reported is the mean difference over the entire course of the study. | All subjects with a baseline and at least one on-treatment MMSE evaluation. As placebo given twice or three times a day would not be expected to differences in outcome, per the protocol and statistical analysis plan (SAP) the placebo group was considered as one group, regardless of whether they received placebo BID or TID. | Scores on a scale | MEAN |
| SECONDARY | Neuropsychiatric Inventory (NPI-10) - Mean Change in Hallucinations Domain Score | As the analysis was by Mixed Model for Repeated Measures, all time points at which NPI-10 was assessed (weeks 4, 8 and 16) was utilized in the analysis. The difference reported is the mean difference over the entire course of the study. | All subjects with a baseline and at least one on-treatment NPI-10 evaluation. As placebo given twice or three times a day would not be expected to differences in outcome, per the protocol and statistical analysis plan (SAP) the placebo group was considered as one group, regardless of whether they received placebo BID or TID. | Score on a scale | MEAN |
| SECONDARY | International Shopping List Test (ISLT) - Immediate Recall | As the analysis was by Mixed Model for Repeated Measures, both time points at which ISLT was assessed (Weeks 4, 8 and 16) was utilized in the analysis. The difference reported is the mean difference over the entire course of the study. | All participants with at least one on-treatment ISLT immediate recall evaluation available. As placebo given twice or three times a day would not be expected to differences in outcome, per the protocol and statistical analysis plan (SAP) the placebo group was considered as one group, regardless of whether they received placebo BID or TID. | Scores on a scale | MEAN |
| SECONDARY | Timed Up and Go Test (TUG) | As the analysis was by Mixed Model for Repeated Measures, both time points at which the TUG was assessed (week 8 and 16) was utilized in the analysis. The difference reported is the mean difference over the entire course of the study. | All subjects with a baseline and at least one on-treatment TUG evaluation. As placebo given twice or three times a day would not be expected to differences in outcome, per the protocol and statistical analysis plan (SAP) the placebo group was considered as one group, regardless of whether they received placebo BID or TID. | Seconds | MEAN |
| SECONDARY | Quantitative Electroencephalogram (qEEG)m - Dominant Peak Frequency Over Parietal Lobe | 16 weeks | All subjects with a baseline and week 16 EEG recording. | Hz | MEAN |
Source ClinicalTrials.gov
Results by group50
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Composite Z-score of a Study-specific Neuropsychological Test Battery (NTB) Including Tests From Cogstate Battery, Letter Fluency Test and Category Fluency Test | Neflamapimod TID | Baseline | 0.06 | Standard Error 0.17 | Z-Score |
| Composite Z-score of a Study-specific Neuropsychological Test Battery (NTB) Including Tests From Cogstate Battery, Letter Fluency Test and Category Fluency Test | Neflamapimod BID | Baseline | 0.02 | Standard Error 0.15 | Z-Score |
| Composite Z-score of a Study-specific Neuropsychological Test Battery (NTB) Including Tests From Cogstate Battery, Letter Fluency Test and Category Fluency Test | Placebo | Baseline | 0.05 | Standard Error 0.11 | Z-Score |
| Composite Z-score of a Study-specific Neuropsychological Test Battery (NTB) Including Tests From Cogstate Battery, Letter Fluency Test and Category Fluency Test | Neflamapimod TID | Week 4 | 0.17 | Standard Error 0.14 | Z-Score |
| Composite Z-score of a Study-specific Neuropsychological Test Battery (NTB) Including Tests From Cogstate Battery, Letter Fluency Test and Category Fluency Test | Neflamapimod BID | Week 4 | -0.08 | Standard Error 0.18 | Z-Score |
| Composite Z-score of a Study-specific Neuropsychological Test Battery (NTB) Including Tests From Cogstate Battery, Letter Fluency Test and Category Fluency Test | Placebo | Week 4 | -0.05 | Standard Error 0.13 | Z-Score |
| Composite Z-score of a Study-specific Neuropsychological Test Battery (NTB) Including Tests From Cogstate Battery, Letter Fluency Test and Category Fluency Test | Neflamapimod TID | Week 8 | 0.28 | Standard Error 0.16 | Z-Score |
| Composite Z-score of a Study-specific Neuropsychological Test Battery (NTB) Including Tests From Cogstate Battery, Letter Fluency Test and Category Fluency Test | Neflamapimod BID | Week 8 | -0.12 | Standard Error 0.18 | Z-Score |
| Composite Z-score of a Study-specific Neuropsychological Test Battery (NTB) Including Tests From Cogstate Battery, Letter Fluency Test and Category Fluency Test | Placebo | Week 8 | 0.05 | Standard Error 0.17 | Z-Score |
| Composite Z-score of a Study-specific Neuropsychological Test Battery (NTB) Including Tests From Cogstate Battery, Letter Fluency Test and Category Fluency Test | Neflamapimod TID | Week 16 | 0.21 | Standard Error 0.18 | Z-Score |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Neflamapimod TID | 20 | |
| Overall Study | STARTED | Neflamapimod BID | 26 | |
| Overall Study | STARTED | Placebo TID | 27 | |
| Overall Study | STARTED | Placebo BID | 18 | |
| Overall Study | COMPLETED | Neflamapimod TID | 20 | |
| Overall Study | COMPLETED | Neflamapimod BID | 20 | |
| Overall Study | COMPLETED | Placebo TID | 26 | |
| Overall Study | COMPLETED | Placebo BID | 15 | |
| Overall Study | NOT COMPLETED | Neflamapimod TID | 0 | |
| Overall Study | NOT COMPLETED | Neflamapimod BID | 6 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events36
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhea | Gastrointestinal disorders | Neflamapimod TID | 3 | 20 | 3 |
| other | Diarrhea | Gastrointestinal disorders | Neflamapimod BID | 0 | 26 | 0 |
| other | Diarrhea | Gastrointestinal disorders | Placebo | 5 | 45 | 5 |
| other | Nausea | Gastrointestinal disorders | Neflamapimod TID | 1 | 20 | 1 |
| other | Nausea | Gastrointestinal disorders | Neflamapimod BID | 2 | 26 | 2 |
| other | Nausea | Gastrointestinal disorders | Placebo | 3 | 45 | 3 |
| other | Fall | Injury, poisoning and procedural complications | Neflamapimod TID | 1 | 20 | 1 |
| other | Fall | Injury, poisoning and procedural complications | Neflamapimod BID | 5 | 26 | 5 |
| other | Fall | Injury, poisoning and procedural complications | Placebo | 4 | 45 | 5 |
| other | Headache | Nervous system disorders | Neflamapimod TID | 3 | 20 | 3 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Neflamapimod TID | 0 | 20 |
| Total, all-cause mortality | Neflamapimod BID | 0 | 26 |
| Total, all-cause mortality | Placebo | 2 | 45 |
| Total, other adverse events | Neflamapimod TID | 8 | 20 |
| Total, other adverse events | Neflamapimod BID | 8 | 26 |
| Total, other adverse events | Placebo | 17 | 45 |
| Total, serious adverse events | Neflamapimod TID | 0 | 20 |
| Total, serious adverse events | Neflamapimod BID | 3 | 26 |
| Total, serious adverse events | Placebo | 4 | 45 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests3
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| 1-Back Task | Primary outcome | ConductCognition |
| Category Fluency | Primary outcome | ConductCognition |
| Verbal Fluency | Primary outcome | ConductCognition |
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04001517
GET https://conductscience.org/api/trials/v1/NCT04001517/results?page=2