NCT03402659

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

A Double-Blind, Placebo-Controlled Proof-of-Concept Study of a Selective p38 MAP Kinase Alpha Inhibitor, Neflamapimod, Administered for 24 Weeks in Subjects With Mild Alzheimer's Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 161 (actual)
• Sponsor: EIP Pharma Inc · Industry
• Sex: All
• Age: 55 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Details provided elsewhere.

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DRUG	neflamapimod	40 mg neflamapimod capsule
OTHER	placebo	matching placebo capsule

Timeline

• Start date: 2017-12-29
• Primary completion: 2019-06-30
• Completion: 2019-07-31
• First posted: 2018-01-18
• Last updated: 2021-10-27
• Results posted: 2021-10-27

Locations

38 sites across 5 countries: United States, Czechia, Denmark, Netherlands, United Kingdom

Regulatory

• FDA-regulated drug study