CLINICAL TRIALS PROFILE FOR NEFLAMAPIMOD

Clinical Trials for neflamapimod

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT03402659 ↗	Proof-of-Concept Study of a Selective p38 MAPK Alpha Inhibitor, Neflamapimod, in Subjects With Mild Alzheimer's Disease	Completed	VU University Medical Center	Phase 2	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.
NCT03402659 ↗	Proof-of-Concept Study of a Selective p38 MAPK Alpha Inhibitor, Neflamapimod, in Subjects With Mild Alzheimer's Disease	Completed	Worldwide Clinical Trials	Phase 2	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.
NCT03402659 ↗	Proof-of-Concept Study of a Selective p38 MAPK Alpha Inhibitor, Neflamapimod, in Subjects With Mild Alzheimer's Disease	Completed	EIP Pharma Inc	Phase 2	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.
NCT03402659 ↗	Proof-of-Concept Study of a Selective p38 MAPK Alpha Inhibitor, Neflamapimod, in Subjects With Mild Alzheimer's Disease	Completed	EIP Pharma, LLC	Phase 2	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.
NCT03435861 ↗	Effect of Neflamapimod on Brain Inflammation in Alzheimer's Disease Patients	Recruiting	Fondation Plan Alzheimer	Phase 2	For this project, neflamapimod and placebo will be provided free of charge by the EIP company (www.eippharma.com). Neflamapimod is currently tested in 2 clinical trials in AD, one in Europe (The Netherlands) and one in the USA (clinical trials.gov/VX-745). The company commenced in May 2015 dosing in two phase 2a clinical studies in patients with Early AD: one in the Netherlands that is focused on PET amyloid imaging as the primary biomarker of drug effect, and one in the US (California) that is focused on Cerebrospinal fluid (CSF) evaluation to determine CSF drug concentrations and effects on inflammatory markers and disease biomarkers. Pharmacokinetic evaluation in these patients has demonstrated blood drug concentration levels in the predicted therapeutic range; and importantly, the data from the US study demonstrate that the drug achieves target drug concentrations in CSF, thus confirming the drug robustly enters the brain in humans. The present project offers us a unique chance to test this promising drug in AD patients. The aim of the study is to focus on PET neuroinflammation imaging as the primary biomarker of this drug effect. The chosen biomarker for imaging neuroinflammation in patients is [1 8F]-DPA714.

Clinical Trial Conditions for neflamapimod

Condition Name

Condition Name
Intervention	Trials
Alzheimer Disease	2
Dementia With Lewy Bodies (DLB)	2
Ischaemic Stroke	1
Moderate to Severe Acute Ischaemic Stroke	1

Condition MeSH

Condition MeSH
Intervention	Trials
Dementia	3
Lewy Body Disease	3
Alzheimer Disease	2
Speech	1

Clinical Trial Locations for neflamapimod

Trials by Country

Trials by Country
Location	Trials
United States	27
Australia	3
Netherlands	2
France	2
United Kingdom	2

Trials by US State

Trials by US State
Location	Trials
Florida	3
Pennsylvania	2
Ohio	2
Minnesota	2
Washington	2

Clinical Trial Progress for neflamapimod

Clinical Trial Phase

Clinical Trial Phase
Clinical Trial Phase	Trials
PHASE2	3
Phase 2	5

Clinical Trial Status

Clinical Trial Status
Clinical Trial Phase	Trials
Recruiting	4
Completed	2
Terminated	1

Clinical Trial Sponsors for neflamapimod

Sponsor Name

Sponsor Name
Sponsor	Trials
EIP Pharma Inc	7
CervoMed, Inc	3
Worldwide Clinical Trials	3

Sponsor Type

Sponsor Type
Sponsor	Trials
Industry	11
Other	6
UNKNOWN	3