CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 91 enrolled
Drug / intervention
Neflamapimoddrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04001517
NCT04001517Phase 2Completed
CompareCT.gov

A Double-Blind, Placebo-Controlled 16-Week Study of the Cognitive Effects of Oral p38 Alpha Kinase Inhibitor Neflamapimod in Dementia With Lewy Bodies (DLB)

EIP Pharma Inc·interventional·Posted Jun 28, 2019·Updated Jun 29, 2023

In Brief

A Phase 2 clinical trial evaluating Neflamapimod for Dementia With Lewy Bodies (DLB). Completed, enrolled 91 participants across 24 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDementia With Lewy Bodies (DLB)
CountriesNetherlands, United States
CollaboratorsWorldwide Clinical Trials

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedJun 28, 2019
Enrollment StartSep 30, 2019
Primary CompletionJun 30, 2020
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 7.0 years ago

Interventions

Neflamapimoddrug

Double-Blind, Placebo-Controlled