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NCT04001517 · ClinicalTrials.gov registry record · Phase 2
Cognitive Effects of Oral p38 Alpha Kinase Inhibitor Neflamapimod in Dementia With Lewy Bodies
A Phase 2 study, sponsored by EIP Pharma.
- Completed
- Registry status
- Phase 2
- Development phase
- 91
- Enrollment target
NCT04001517: Completed Phase 2 study, sponsored by EIP Pharma.
NCT04001517 is a Phase 2 study that has completed, run by EIP Pharma. The registered enrollment target is 91 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04001517, a Phase 2 study, has completed, sponsored by EIP Pharma.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 91 participants
- Enrollment target
Study Summary
This is a Phase 2, multi-center, randomized, double-blind, placebo-controlled, proof-of-principle study of neflamapimod versus matching placebo (randomized 1:1) administered with food for 16 weeks in subjects with DLB. The primary objective is to evaluate the effect of neflamapimod on cognitive function as assessed in a study-specific Cogstate Neuropsychological Test Battery (NTB). Secondary endpoints include the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB), Mini-Mental State Examination (MMSE), Neuropsychiatric Inventory (NPI-10), Timed Up and Go Test, and electroencephalogram (EEG) as a potential biomarker for DLB.
Primary Outcome
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
Interventions
- DRUG Neflamapimod
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 91 participants |
| Start Date | 2019-09-30 |
| Est. Completion | 2020-06-30 |
| Phase | Phase 2 |
What the finished NCT04001517 record still lists
NCT04001517 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 91 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% lower).
The record links to 0 conditions, and to 1 intervention - of which Neflamapimod is the first listed.
NCT04001517 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04001517 about?
NCT04001517 is a clinical study titled "Cognitive Effects of Oral p38 Alpha Kinase Inhibitor Neflamapimod in Dementia With Lewy Bodies". This is a Phase 2, multi-center, randomized, double-blind, placebo-controlled, proof-of-principle study of neflamapimod versus matching placebo (randomized 1:1) administered with food for 16 weeks in subjects with DLB. The primary objective is to evaluate the effect of neflamapimod on cognitive func...
What is the current status of trial NCT04001517?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 91 participants. The study started on 2019-09-30. Estimated completion is 2020-06-30.
What interventions are being tested in trial NCT04001517?
The interventions under investigation include: Neflamapimod (DRUG).
Who is sponsoring clinical trial NCT04001517?
This trial is sponsored by EIP Pharma, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04001517's enrollment target sits among peer trials
91 771st of 2000 higher than 1,229 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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