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

NCT03402659 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 161

Last updated 2021-10-27

Study results available
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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

  • Alzheimer Disease

Interventions

DRUG

neflamapimod

40 mg neflamapimod capsule

OTHER

placebo

matching placebo capsule

Sponsors & Collaborators

  • Worldwide Clinical Trials

    collaborator OTHER

  • Amsterdam UMC, location VUmc

    collaborator OTHER

  • EIP Pharma Inc

    lead INDUSTRY

Principal Investigators

  • John Alam, MD · EIP Pharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-29
Primary Completion
2019-06-30
Completion
2019-07-31
FDA Drug
Yes

Countries

  • United States
  • Czechia
  • Denmark
  • Netherlands
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03402659 on ClinicalTrials.gov