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NCT03402659 · ClinicalTrials.gov registry record · Phase 2
Proof-of-Concept Study of a Selective p38 MAPK Alpha Inhibitor, Neflamapimod, in Subjects With Mild Alzheimer's Disease
A Phase 2 study of Alzheimer Disease, sponsored by EIP Pharma.
- Completed
- Registry status
- Phase 2
- Development phase
- 161
- Enrollment target
- 20
- Study locations
NCT03402659 is a Phase 2 study of Alzheimer Disease that has completed, run by EIP Pharma. The registered enrollment target is 161 participants, below the 2,750-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (94% lower). The trial reports 20 study locations across 8 states.
The verdict
NCT03402659, a Phase 2 study of Alzheimer Disease, has completed, sponsored by EIP Pharma.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 161 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a phase 2b, double-blind, placebo controlled proof-of-concept study of a an oral small molecule selective inhibitor of p38 alpha kinase, neflamapimod, administered for 24 weeks in subjects with mild Alzheimer's disease. The primary objective is to demonstrate significant improvement relative to placebo-treatment in episodic memory function, as assessed by the Hopkins Verbal Learning Test. Secondary endpoints include Clinical Dementia Rating scale (CDR), Wechsler Memory Scale (WMS), Mini-Mental-Status-Examination (MMSE) and Cerebrospinal fluid (CSF) biomarkers of AD disease activity and progression.
Conditions Studied
Interventions
- OTHER placebo
- DRUG neflamapimod
Study Locations (20)
Florida
- Miami Dade Medical Research Institute - Miami
- Sensible Healthcare, LLC - Ocoee
- Anchor Neuroscience - Pensacola
- Progressive Medical Research - Port Orange
- Suncoast Neuroscience Associates, Inc. - St. Petersburg
- Florida Premier Research Institute - Winter Park
California
- Alliance for Research - Long Beach
- Pacific Research Network - San Diego
- CITrials - Santa Ana
- Southern California Research, LLC - Simi Valley
- Viking Clinical Research - Temecula
Other
- Neuro HK, s.r.o. POLIKLINIKA CHOCEŇ, a.s. - Choceň
- Cerebrovaskulární poradna s.r.o. - Moravská Ostrava
- Clintrial S.R.O - Prague
- Private Psychiatric Centre - Prague
Idaho
- Northwest Clinical Trials - Boise
Massachusetts
- MassGeneral Institute for Neurodegenerative Disease - Charlestown
New York
- Manhattan Behavioral Medicine - New York
North Carolina
- Alzheimer's Memory Center and Research Institute - Charlotte
Washington
- Northwest Clinical Research Center - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 161 participants |
| Start Date | 2017-12-29 |
| Est. Completion | 2019-07-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03402659
The ClinicalTrials.gov registry entry for NCT03402659 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 161 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,750-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (94% lower). The listed sponsor is EIP Pharma, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Alzheimer Disease appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.
NCT03402659 reports 20 study locations spanning 8 distinct geographic areas - top geographies include Florida, California, Other.
Frequently Asked Questions
What is clinical trial NCT03402659 about?
NCT03402659 is a clinical study titled "Proof-of-Concept Study of a Selective p38 MAPK Alpha Inhibitor, Neflamapimod, in Subjects With Mild Alzheimer's Disease". This is a phase 2b, double-blind, placebo controlled proof-of-concept study of a an oral small molecule selective inhibitor of p38 alpha kinase, neflamapimod, administered for 24 weeks in subjects with mild Alzheimer's disease. The primary objective is to demonstrate significant improvement relative...
What is the current status of trial NCT03402659?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 161 participants. The study started on 2017-12-29. Estimated completion is 2019-07-31.
What conditions does trial NCT03402659 study?
This clinical trial studies the following conditions: Alzheimer Disease.
What interventions are being tested in trial NCT03402659?
The interventions under investigation include: placebo (OTHER), neflamapimod (DRUG).
Who is sponsoring clinical trial NCT03402659?
This trial is sponsored by EIP Pharma, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03402659 being conducted?
This trial has 20 study locations across California, Florida, Idaho, Massachusetts, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.