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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 is a Phase 2 study that has completed, run by EIP Pharma. The registered enrollment target is 91 participants.
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.
Interventions
- DRUG Neflamapimod
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 91 participants |
| Start Date | 2019-09-30 |
| Est. Completion | 2020-06-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04001517
The ClinicalTrials.gov registry entry for NCT04001517 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 91 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is EIP Pharma, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Neflamapimod is the first listed.
NCT04001517 reports 0 study locations.
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.
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