Trials / Completed
CompletedNCT04001517
Cognitive Effects of Oral p38 Alpha Kinase Inhibitor Neflamapimod in Dementia With Lewy Bodies
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)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 91 (actual)
- Sponsor
- EIP Pharma Inc · Industry
- Sex
- All
- Age
- 55 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Neflamapimod | Double-Blind, Placebo-Controlled |
Timeline
- Start date
- 2019-09-30
- Primary completion
- 2020-06-30
- Completion
- 2020-06-30
- First posted
- 2019-06-28
- Last updated
- 2023-06-29
- Results posted
- 2021-11-02
Locations
24 sites across 2 countries: United States, Netherlands
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04001517. Inclusion in this directory is not an endorsement.