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COMPLETED Phase 2

Proof-of-Concept Study of a Selective p38 MAPK Alpha Inhibitor, Neflamapimod, in Subjects With Mild Alzheimer's Disease

NCT03402659 · View on ClinicalTrials.gov ↗

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

FieldValue
Enrollment Target 161 participants
Start Date 2017-12-29
Est. Completion 2019-07-31
Phase Phase 2

Sponsor

EIP Pharma

3 total trials

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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 161 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is EIP Pharma, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03402659 reports 20 study locations spanning 8 distinct geographic areas — top geographies include Florida, California, Other. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03402659?

The interventions under investigation include: placebo (OTHER), neflamapimod (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03402659?

This trial is sponsored by EIP Pharma, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial