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Clinical trial

Cognitive Effects of Oral p38 Alpha Kinase Inhibitor Neflamapimod in Dementia With Lewy Bodies (AscenD-LB)

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Last updated:30th Sep 2019
Identifier: NCT04001517

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 Type: Interventional  (Clinical Trial)
Estimated Enrollment: 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date: September 30, 2019
Estimated Primary Completion Date: June 2020
Estimated Study Completion Date: June 2020

Arms:
- Experimental:
Neflamapimod
- Placebo Comparator: Placebo

Category Value
Date last updated at source 2019-10-24
Study type(s) Interventional
Expected enrolment 80
Study start date 2019-09-30
Estimated primary completion date 2020-06-01

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